Clinical Trials /

A Personalized Medicine Study for Patients With Advanced Cancer of the Breast, Prostate, Pancreas or Those With Refractory Acute Myelogenous Leukemia

NCT03878524

Description:

This Phase Ib study assesses feasibility and safety of a personalized medicine approach that utilizes a series of clinical study analytics to characterize the cancer based on DNA mutations, RNA and protein expression, physical and molecular architecture of the cancer tissue, and function of cells. This clinical study analytics will be considered by a tumor board to select therapeutic drug combinations tailored to each individual. The chosen drugs are intended to optimally inhibit and/or perturb biological pathways promoting the growth and/or survival of an individual participant's cancer. Serial biopsies and analytics will allow for the therapy to adapt as the patient's cancer adapts to biological perturbation. The study will include patients with advanced cancer of the breast (BCa), prostate (PCa), or pancreas (PanCa), or those with refractory acute myelogenous leukemia (AML).

Related Conditions:
  • Acute Myeloid Leukemia
  • Breast Carcinoma
  • Pancreatic Carcinoma
  • Prostate Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Personalized Medicine Study for Patients With Advanced Cancer of the Breast, Prostate, Pancreas or Those With Refractory Acute Myelogenous Leukemia
  • Official Title: Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) Trial

Clinical Trial IDs

  • ORG STUDY ID: STUDY00015588
  • NCT ID: NCT03878524

Conditions

  • Breast Cancer
  • Prostate Cancer
  • Pancreatic Cancer
  • Acute Myelogenous Leukemia

Interventions

DrugSynonymsArms
ABIRATERONEZYTIGA®SMMART Therapy (Combination Drug A & B)
ENZALUTAMIDEXtandi®SMMART Therapy (Combination Drug A & B)
VENETOCLAXVenclexta®SMMART Therapy (Combination Drug A & B)
PALBOCICLIBIBRANCE®SMMART Therapy (Combination Drug A & B)
All-trans Retinoic AcidATRA, tretinoin, Vesanoid®SMMART Therapy (Combination Drug A & B)
BORTEZOMIBVelcade®SMMART Therapy (Combination Drug A & B)
CABAZITAXELJevtana®SMMART Therapy (Combination Drug A & B)
OXALIPLATIN1-OHP, L-OHP, oxalatoplatin, oxaliplatinum, Eloxatin®SMMART Therapy (Combination Drug A & B)
FLUOROURACIL5-fluorouracil, 5-FU, Adrucil™, Carac™, Efudex™, Efudix™SMMART Therapy (Combination Drug A & B)
FOLINIC ACIDcalcium folinate, citrovorum factor, Leucovorin®SMMART Therapy (Combination Drug A & B)
CARBOPLATINSMMART Therapy (Combination Drug A & B)
PANOBINOSTATFarydak®SMMART Therapy (Combination Drug A & B)
VORINOSTATZolinza®SMMART Therapy (Combination Drug A & B)
PEMBROLIZUMABKeytrudaSMMART Therapy (Combination Drug A & B)
BEVACIZUMABrhuMAb VEGF, Avastin®SMMART Therapy (Combination Drug A & B)
IPILIMUMABYervoy®SMMART Therapy (Combination Drug A & B)
NIVOLUMABOpdivo®SMMART Therapy (Combination Drug A & B)
EVEROLIMUSSMMART Therapy (Combination Drug A & B)
SIROLIMUSRapamune®SMMART Therapy (Combination Drug A & B)
CELECOXIBCelebrex®SMMART Therapy (Combination Drug A & B)
OLAPARIBLynparza®SMMART Therapy (Combination Drug A & B)
AFATINIBGilotrif®SMMART Therapy (Combination Drug A & B)
CABOZANTINIBCABOMETYX®SMMART Therapy (Combination Drug A & B)
SORAFENIBNexavar®SMMART Therapy (Combination Drug A & B)
DASATINIBSprycel®SMMART Therapy (Combination Drug A & B)
ERLOTINIBTarceva®SMMART Therapy (Combination Drug A & B)
IDELALISIBZydelig®SMMART Therapy (Combination Drug A & B)
IMATINIBGleevac®SMMART Therapy (Combination Drug A & B)
LENVATINIBLenvima®SMMART Therapy (Combination Drug A & B)
PERTUZUMABPerjeta®SMMART Therapy (Combination Drug A & B)
PONATINIBIclusig®SMMART Therapy (Combination Drug A & B)
RUXOLITINIBJakafi®SMMART Therapy (Combination Drug A & B)
SUNITINIBSutent®SMMART Therapy (Combination Drug A & B)
TRAMETINIBMekinist®SMMART Therapy (Combination Drug A & B)
VEMURAFENIBZelbraf®SMMART Therapy (Combination Drug A & B)

Purpose

This Phase Ib study assesses feasibility and safety of a personalized medicine approach that utilizes a series of clinical study analytics to characterize the cancer based on DNA mutations, RNA and protein expression, physical and molecular architecture of the cancer tissue, and function of cells. This clinical study analytics will be considered by a tumor board to select therapeutic drug combinations tailored to each individual. The chosen drugs are intended to optimally inhibit and/or perturb biological pathways promoting the growth and/or survival of an individual participant's cancer. Serial biopsies and analytics will allow for the therapy to adapt as the patient's cancer adapts to biological perturbation. The study will include patients with advanced cancer of the breast (BCa), prostate (PCa), or pancreas (PanCa), or those with refractory acute myelogenous leukemia (AML).

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine the feasibility of implementing an individualized treatment strategy across
      several different cancer types based upon a comprehensive assessment of tumor and patient
      characteristics.

      SECONDARY OBJECTIVES:

      I. To describe the tolerability of implementing an individualized treatment strategy,
      particularly by measuring unanticipated toxicity associated with the administration of
      different combinations of two therapeutic agents given to an individual participant.

      II. To determine the response rate, within each of the four disease cohorts (i.e., BCa, PCa,
      PanCa, AML).

      III. To determine the progression-free survival, within each of the four disease cohorts
      (i.e., BCa, PCa, PanCa, AML).

      IV. To determine overall and disease-specific survival within each of the four disease
      cohorts (i.e., BCa, PCa, PanCa, AML).

      V. To determine the time to decline in a participant's ability to perform activities of daily
      living.

      EXPLORATORY OBJECTIVES:

      I. To measure quality of life among enrolled participants. II. To evaluate immune response
      for participants receiving immunomodulatory therapy.

      III. To correlate baseline and on study clinical parameters with tumor characteristics as
      assessed by clinical and research-based analytics.

      IV. To enhance integration of clinical and basic research activities, so as to advance our
      understanding of cancer biology and how that knowledge can be used to improve patient care.

      V. To assess tumor characteristics and, ultimately, our understanding of human cancer biology
      using of a panel of research-based analytical assays.

      OUTLINE: This is an open-label, Phase Ib that consists of novel combination drug treatment
      regimens derived from a set list of 35 drug agents or chemotherapeutic combinations.

      Participants will undergo an initial tumor tissue/cell biopsy (Biopsy #1) which will be
      performed prior to initiation of their last standard of care therapy. This biopsy will be
      analyzed using Clinical Study Analytics and imaging assessments to derive an in-depth
      cellular and molecular profile of an individual participant's cancer. The findings will be
      presented to a dedicated clinical tumor board that will be convened to exercise its
      collective clinical judgment, following a defined SMMART drug decision logic to assign an
      individualized SMMART therapeutic regimen (Therapy #1). This therapeutic regimen consists of
      a rational combination of two drugs. These drug agents may be administered in combination,
      either concurrently or serially depending on their respective pharmacology.

      Participants that have progressive disease following completion of their standard of care
      therapy may begin their selected SMMART therapeutic regimen (Therapy #1). Participants will
      undergo a second biopsy (Biopsy #2) prior to starting Therapy #1. The biopsy and imaging
      assessments will be analyzed (similar to Biopsy #1) and findings will be presented a second
      clinical tumor board that will determine a second on-study therapeutic regimen (Therapy #2).

      Therapy #1 and all subsequent therapies will involve two drugs (Drug A and Drug B), whose
      doses will be escalated within individual patients over time. As described in detail below,
      escalation will occur on a monthly basis and is anticipated to occur as follows: first month
      -- 100% dose Drug A+25% dose Drug B; second month --100% dose Drug A + 50% dose Drug B; third
      month -- 100% dose Drug A + 100% dose Drug B.

      After three months of Therapy #1, participants will undergo Biopsy #3. The tumor biopsy along
      with imaging assessments will be will be used to inform a third clinical tumor board.
      Following the same schema described for choosing Therapies #1 and #2, this tumor board will
      deliberate on the results of to assign a third Therapy #3.

      After 3 cycles (with a cycle equated to 28 days) of Therapy #1, participants demonstrating
      stable disease (SD), partial response (Pr), or complete response (CR) will continue Therapy
      #1 for an additional 3 cycles (i.e., an additional 3 months, for a total of 6 cycles or 6
      months). If participants clinically progress or cannot tolerate their assigned treatment,
      they may be eligible to receive the next assigned therapy (i.e., Therapy #2). This is an
      iterative process and continues with each SMMART therapeutic regimen; thus, if participants
      show PD while receiving Therapy #2, they may be eligible to receive the next ascribed
      treatment regimen (e.g., Therapy #3), and so on. Each therapy will be based on the preceding
      biopsy. In general, there is no limit to the number of serial therapeutic regimens a
      participant can receive and it is possible for participants to experience PD and remain
      on-study. However, participants must continue to meet treatment eligibility criteria.
      Recognizing that participants who fail to respond to serial therapeutic regimens will
      experience a generalized clinical decline, individuals who experience a decline in their
      performance status will not receive any further therapy.

      Participants who discontinue therapy or withdraw may participate in follow up which consists
      of reimaging and history and physical at least every three months.
    

Trial Arms

NameTypeDescriptionInterventions
SMMART Therapy (Combination Drug A & B)ExperimentalFollowing a tumor tissue/cell biopsy, participants will be assigned an individualized therapy involving a combination two drugs (Drug A and Drug B) selected from a list of 35 drugs (ABIRATERONE, ENZALUTAMIDE, VENETOCLAX, PALBOCICLIB, All-trans Retinoic Acid , BORTEZOMIB, CABAZITAXEL, OXALIPLATIN, FLUOROURACIL, FOLINIC ACID, CARBOPLATIN, PANOBINOSTAT, VORINOSTAT, PEMBROLIZUMAB, BEVACIZUMAB, IPILIMUMAB, NIVOLUMAB, EVEROLIMUS, SIROLIMUS, CELECOXIB, OLAPARIB, AFATINIB, CABOZANTINIB, SORAFENIB, DASATINIB, ERLOTINIB, IDELALISIB, IMATINIB, LENVATINIB, PERTUZUMAB, PONATINIB, RUXOLITINIB, SUNITINIB, TRAMETINIB, VEMURAFENIB). Doses will be escalated on a monthly basis and is anticipated to occur as follows: first month -- 100% dose Drug A+25% dose Drug B; second month --100% dose Drug A + 50% dose Drug B; third month -- 100% dose Drug A + 100% dose Drug B. These drug agents may be administered in combination, either concurrently or serially depending on their respective pharmacology.
  • ABIRATERONE
  • ENZALUTAMIDE
  • VENETOCLAX
  • PALBOCICLIB
  • All-trans Retinoic Acid
  • BORTEZOMIB
  • CABAZITAXEL
  • OXALIPLATIN
  • FLUOROURACIL
  • FOLINIC ACID
  • CARBOPLATIN
  • PANOBINOSTAT
  • VORINOSTAT
  • PEMBROLIZUMAB
  • BEVACIZUMAB
  • IPILIMUMAB
  • NIVOLUMAB
  • EVEROLIMUS
  • SIROLIMUS
  • CELECOXIB
  • OLAPARIB
  • AFATINIB
  • CABOZANTINIB
  • SORAFENIB
  • DASATINIB
  • ERLOTINIB
  • IDELALISIB
  • IMATINIB
  • LENVATINIB
  • PERTUZUMAB
  • PONATINIB
  • RUXOLITINIB
  • SUNITINIB
  • TRAMETINIB
  • VEMURAFENIB

Eligibility Criteria

        Inclusion Criteria:

          -  Ability to understand and the willingness to sign a written informed consent document.

          -  Participants ≥ 21 years old at time of informed consent. Both men and women and
             members of all races and ethnic groups will be included.

          -  Participants, both men and women, must agree to use an adequate method of
             contraception prior to Study entry, for the duration of Study participation, and for 4
             months after completion of Study.

          -  Women of childbearing potential must have a negative serum or urine pregnancy test
             within 14 days prior to start of Study drug administration.

          -  Participants must have histologically documented BCa, PCa, or PanCa, or pathologically
             documented AML.

          -  Participants with BCa, PCa, or AML must have progressed following standard therapy, as
             described in detail below for each of these diseases. Patients with PanCa will be
             eligible irrespective of prior treatment, inclusive of those who have not received any
             prior treatment. Participants who due to medical issues cannot receive other standard
             therapy that has been shown to prolong survival will be eligible, if other eligibility
             criteria are met.

          -  Participants in BCa, PCa, or PanCa cohorts must have metastatic disease.

               1. For BCa and PanCa and for PCa participants with soft tissue disease, this is
                  defined by at least one lesion that can be accurately measured in at least one
                  dimension (longest diameter to be recorded for non-nodal lesions and short axis
                  for nodal lesions) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with
                  spiral CT scan, per RECIST (v1.1).

               2. For PCa, participants with lesions on a bone scan that are considered distinctly
                  metastatic will also be included.

          -  Participants in AML cohort must have pathologically confirmed AML per WHO diagnostic
             criteria and have their bone marrow biopsy and aspirate reviewed at OHSU.

          -  Participants in BCa, PanCa, and PCa cohorts, must have lesions meeting the above
             criteria also and must be amenable to image guided or direct vision biopsy.

          -  Participants must not currently be receiving any other investigational agents.

          -  Participants must have ECOG performance status ≤ 1 (Karnofsky ≥ 80%) and a physician
             assessed life expectancy of ≥ 6 months.

          -  Participants must have adequate organ function (defined in protocol) at time of
             registration and within 4 weeks prior to initiating on-protocol treatment.

          -  Any prior therapy, radiotherapy (except palliative radiation therapy of 30 Gy or
             less), or major surgery must have been completed ≥ 4 weeks prior to start of
             treatment. All adverse events due to prior therapy have resolved to a Grade 1 or
             better (except alopecia and lymphopenia and hematologic toxicity in AML) by start of
             treatment. Palliative radiation therapy must have been completed at least 2 weeks
             prior to start of treatment. The radiotherapy must not be to a lesion that is included
             as measurable disease.

          -  All potential participants must be discussed with and specifically approved by the
             Study PI.

        CANCER SPECIFIC INCLUSION CRITERIA: Breast Cancer (BCa)

          -  Participants must have progressive disease.

          -  Participants considered to have hormone receptor positive disease and/or those
             considered to have HER2 positive disease must have failed all prior therapies
             considered to be standard of care based upon hormone receptor and HER2 expression
             status.

          -  Participants who are considered to have failed hormone or HER2 directed therapy but
             are still maintained on those respective lines of agents per standard of care practice
             will be considered on a case-by-case basis for participation in the Study while still
             receiving such agents.

          -  Participants must be about to begin chemotherapy.

          -  Participants with triple negative breast cancer (TNBC) who are about to begin a course
             of chemotherapy are eligible.

        CANCER SPECIFIC INCLUSION CRITERIA: Prostate Cancer (PCa)

          -  Participants must have progressive disease.

          -  Participants must have failed at least one line of hormone therapy in the setting of
             castrate resistant disease (i.e., individuals must have failed initial androgen
             deprivation therapy as well as one line of another hormone therapy).

          -  Participants must have castrate levels of testosterone and are about to begin
             chemotherapy.

        CANCER SPECIFIC INCLUSION CRITERIA: Pancreatic Cancer (PanCa)

          -  Participants with newly diagnosed metastatic disease and are beginning first-line
             treatment with a course of chemotherapy are eligible.

               1. Participants who have failed prior chemotherapy for metastatic disease and are
                  about to begin another line of chemotherapy will be considered on a case-by-case
                  basis.

               2. Adjuvant or neo-adjuvant chemotherapy given in the context of local disease will
                  not count towards number of regimens for metastatic disease.

        CANCER SPECIFIC INCLUSION CRITERIA: Acute Myelogenous Leukemia (AML)

          -  Participants must have primary refractory or relapsed AML with persistent disease
             after receiving two intensive regimens (also termed induction regimens).

          -  Participants who are considered older (i.e., over 60), will be eligible and do not
             have to meet the above requirements. Such individuals will evaluated on a case by case
             basis, but will have failed an initial induction regimen and are not considered bone
             marrow transplant candidates.

          -  Participants may be on hydroxyurea for purposes of controlling WBC counts at the time
             of Study entry (i.e., time of Biopsy #1) and may remain on it during the screening
             part of the study.

               1. Participants may remain on hydroxyurea through the first two cycles of SMMART
                  therapy. It is standard practice to take this approach with refractory AML
                  participants entering onto trials of experimental agents. Continuation of
                  hydroxyurea beyond first two cycles may be allowed on a case by case basis.
                  Hydroxyurea will not count as a SMMART Study drug, i.e., they can remain on
                  hydroxyurea while receiving SMMART Drug A plus Drug B. Co-administration of
                  hydroxyurea will be appropriately documented on treatment plans and relevant case
                  report forms.

        Exclusion Criteria:

          -  Participants with metastases to the central nervous system that are considered
             uncontrolled and/or were diagnosed within the past 4 weeks of screening for this
             Study.

          -  Participants with certain subtypes of cancer will be excluded. The following list
             provides examples but is not all inclusive, and individual situations will be handled
             on a case-by-case basis: neuroendocrine PanCa, small cell PCa, unusual subtypes of
             BCa, acute promyelocytic leukemia (APL).

          -  Participants cannot have an active malignancy of another cancer. Those with a history
             of prior malignancy will be considered on a case-by-case basis. Guiding examples for
             those who can be enrolled include: individuals who have been disease free for >5
             years; individuals who are considered to have a high likelihood of being cured (e.g.,
             prior history of stage 1 rectal cancer and currently otherwise disease free);
             adequately treated localized non-melanomatous skin cancer.

          -  Participants cannot be on other forms of anti-cancer therapy at the same time, except
             as described within this protocol. There must be at least washout period that accounts
             for 5 half-lives of last therapy.

               1. Participants with PCa will continue treatment with androgen deprivation therapy,
                  either by prior castration or treatment with LHRH antagonists or agonists, as is
                  standard practice.

               2. Participants with BCa who are HER2 positive may continue to receive anti-HER2
                  therapy per standard practice guidelines, while participants who are hormone
                  receptor positive may continue to receive hormone therapy per standard practice
                  guidelines.

               3. Participants with AML may continue to receive hydroxyurea for two cycles of
                  SMMART therapy, as described in this protocol.

          -  Participants with medical conditions, inclusive of psychiatric, that in the opinion of
             the investigators would jeopardize the patient or the Study will be excluded.

          -  Participants that are pregnant or breast feeding.

        CANCER SPECIFIC EXCLUSION CRITERIA: Breast Cancer (BCa)

          -  Participants who have already received 3 or more treatment courses with cytotoxic
             agents for metastatic disease typically constitute individuals with compromised organ
             function and performance status and will generally not be considered eligible.

               1. Recognizing that this is not always the case, such individuals will be considered
                  on a case-by-case basis.

               2. Adjuvant chemotherapy will not count towards this number of treatment courses.

        CANCER SPECIFIC EXCLUSION CRITERIA: Prostate Cancer (PCa)

          -  Participants who have already received 2 or more courses with cytotoxic agents
             typically constitute individuals with compromised organ function and performance
             status and will generally not be considered eligible.

               1. Recognizing that this is not always the case, such individuals will be considered
                  on a case-by-case basis.

               2. Chemotherapy administered up front in newly diagnosed metastatic disease (i.e.,
                  at the time of initiation of androgen deprivation therapy, considered standard of
                  care) will not count towards this number.

        CANCER SPECIFIC EXCLUSION CRITERIA: Acute Myelogenous Leukemia (AML)

          -  Participants must not be planning to undergo bone marrow transplant.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:21 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Ability for participants to start on-study treatment based upon on-study measurement after experiencing progressive disease
Time Frame:Within 2 months following progressive disease (PD) from standard of care therapy.
Safety Issue:
Description:Measured as the number of participants to complete first dose of first SMMART therapy (Therapy #1).

Secondary Outcome Measures

Measure:Incidence of Grade 3+ toxicities attributable to assigned study drug(s).
Time Frame:30 days post completion of SMMART Therapy #1 (up to 6 months)
Safety Issue:
Description:Measured with NCI CTCAE Criteria version 5.0
Measure:Response rate for BCa cohort
Time Frame:Completion of SMMART Therapy #1 (up to 6 months)
Safety Issue:
Description:Tumor response will be determined per the investigators' assessment, according to Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and is defined as the sum of Partial response (Pr) and Complete response (CR) divided by the number of all treated participants.
Measure:Response rate for PCa cohort.
Time Frame:Completion of SMMART Therapy #1 (up to 6 months)
Safety Issue:
Description:Tumor response will be determined per the investigators' assessment, according to Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and is defined as the sum of Partial response (Pr) and Complete response (CR) divided by the number of all treated participants.
Measure:Response rate for PanCa cohort
Time Frame:Completion of SMMART Therapy #1 (up to 6 months)
Safety Issue:
Description:Tumor response will be determined per the investigators' assessment, according to Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) and is defined as the sum of Partial response (Pr) and Complete response (CR) divided by the number of all treated participants.
Measure:Response rate for AML cohort.
Time Frame:Completion of SMMART Therapy #1 (up to 6 months)
Safety Issue:
Description:Assessment of clinical response will be made according to revised recommendations of the International Working Group (IWG) for diagnosis, standardization of response criteria, treatment outcomes, and reporting standards for therapeutic Trials in Acute Myeloid Leukemia. Defined as the sum of Partial remission (Pr) and Complete response (CR), CR with incomplete recovery (CRi), Cytogenetic Complete Remission (CRc), molecular CR (CRm), divided by the number of all treated participants.
Measure:Progression Free Survival (PFS) for BCa cohort
Time Frame:Completion of SMMART Therapy #1 (up to 6 months)
Safety Issue:
Description:Average number of days from the start of Therapy #1 to the date of relapse from PR or CR or death from any cause.
Measure:PFS for PCa cohort
Time Frame:Completion of SMMART Therapy #1 (up to 6 months)
Safety Issue:
Description:Average number of days from the start of Therapy #1 to the date of relapse from PR or CR or death from any cause.
Measure:PFS for PanCa cohort
Time Frame:Completion of SMMART Therapy #1 (up to 6 months)
Safety Issue:
Description:Average number of days from the start of Therapy #1 to the date of relapse from PR or CR or death from any cause.
Measure:PFS for AML cohort
Time Frame:Completion of SMMART Therapy #1 (up to 6 months)
Safety Issue:
Description:Average number of days from the start of Therapy #1 to the date of relapse from PR or CR or CR with incomplete recovery (Cri), Cytogenetic Complete Remission (CRc), molecular CR (CRm), or death from any cause
Measure:Overall survival (OS) for entire treatment cohort
Time Frame:Completion of SMMART Therapy #1 (up to 6 months)
Safety Issue:
Description:Overall Survival (OS) is defined as the time (days) from start of treatment (Day 1) to death due to any cause.
Measure:OS for BCa cohort
Time Frame:Completion of SMMART Therapy #1 (up to 6 months)
Safety Issue:
Description:Overall Survival (OS) is defined as the time (days) from start of treatment (Day 1) to death due to any cause.
Measure:OS for PCa cohort
Time Frame:Completion of SMMART Therapy #1 (up to 6 months)
Safety Issue:
Description:Overall Survival (OS) is defined as the time (days) from start of treatment (Day 1) to death due to any cause.
Measure:OS for PanCa cohort
Time Frame:Completion of SMMART Therapy #1 (up to 6 months)
Safety Issue:
Description:Overall Survival (OS) is defined as the time (days) from start of treatment (Day 1) to death due to any cause.
Measure:OS for AML cohort
Time Frame:Completion of SMMART Therapy #1 (up to 6 months)
Safety Issue:
Description:Overall Survival (OS) is defined as the time (days) from start of treatment (Day 1) to death due to any cause.
Measure:Disease specific survival (DSS) for entire treatment cohort
Time Frame:Completion of SMMART Therapy #1 (up to 12 months)
Safety Issue:
Description:DSS is defined as the time from the first day of treatment with Drug A to death as a result of the disease at time of last follow-up at 12 months. Participants that die of causes other than Study disease being assessed will be censored at the time of death.
Measure:DSS for PCa cohort
Time Frame:Completion of SMMART Therapy #1 (up to 12 months)
Safety Issue:
Description:DSS is defined as the time from the first day of treatment with Drug A to death as a result of the disease at time of last follow-up at 12 months. Participants that die of causes other than Study disease being assessed will be censored at the time of death.
Measure:DSS for PanCa cohort
Time Frame:Completion of SMMART Therapy #1 (up to 12 months)
Safety Issue:
Description:DSS is defined as the time from the first day of treatment with Drug A to death as a result of the disease at time of last follow-up at 12 months. Participants that die of causes other than Study disease being assessed will be censored at the time of death.
Measure:DSS for AML cohort
Time Frame:Completion of SMMART Therapy #1 (up to 12 months)
Safety Issue:
Description:DSS is defined as the time from the first day of treatment with Drug A to death as a result of the disease at time of last follow-up at 12 months. Participants that die of causes other than Study disease being assessed will be censored at the time of death.
Measure:Determine Time to Decline (TTD) for BCa cohort
Time Frame:Completion of SMMART Therapy #1 (up to 6 months)
Safety Issue:
Description:Average number of days subjects reach a Easter Cooperative Oncology Group (ECOG) performance status ≥ 3. assessed using cumulative incidence methods.
Measure:Determine Time to Decline (TTD) for PCa cohort
Time Frame:Completion of SMMART Therapy #1 (up to 6 months)
Safety Issue:
Description:Average number of days subjects reach a Easter Cooperative Oncology Group (ECOG) performance status ≥ 3. assessed using cumulative incidence methods.
Measure:Determine Time to Decline (TTD) for PanCa cohort
Time Frame:Completion of SMMART Therapy #1 (up to 6 months)
Safety Issue:
Description:Average number of days subjects reach a Easter Cooperative Oncology Group (ECOG) performance status ≥ 3. assessed using cumulative incidence methods.
Measure:Determine Time to Decline (TTD) for AML cohort
Time Frame:Completion of SMMART Therapy #1 (up to 6 months)
Safety Issue:
Description:Average number of days subjects reach a Easter Cooperative Oncology Group (ECOG) performance status ≥ 3. assessed using cumulative incidence methods.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:OHSU Knight Cancer Institute

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