Clinical Trials /

A Study of LY2880070 in Participants With Advanced or Metastatic Cancer

NCT02632448

Description:

The main purpose of this two-part study is to evaluate the safety and efficacy of the study drug known as LY2880070 in participants with advanced or metastatic solid tumors.

Related Conditions:
  • Breast Carcinoma
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of LY2880070 in Participants With Advanced or Metastatic Cancer
  • Official Title: A Phase 1b/2a Two-Part Open-Label Multicenter Study to Evaluate the Safety and Efficacy of LY2880070 as Monotherapy and in Combination With Gemcitabine in Patients With Advanced or Metastatic Cancer

Clinical Trial IDs

  • ORG STUDY ID: ESPS-001
  • NCT ID: NCT02632448

Conditions

  • Solid Tumors
  • Colorectal Cancer
  • Breast Cancer
  • Ovarian Cancer
  • Colon Cancer
  • Rectal Cancer
  • Neoplasms
  • Endometrial Cancer
  • Soft Tissue Sarcoma
  • Triple Negative Breast Cancer
  • Pancreas Cancer
  • Pancreatic Cancer

Interventions

DrugSynonymsArms
LY2880070Part A: LY2880070
GemcitabineGemzarPart A: LY2880070 with Gemcitabine

Purpose

The main purpose of this two-part study is to evaluate the safety and efficacy of the study drug known as LY2880070 in participants with advanced or metastatic solid tumors.

Trial Arms

NameTypeDescriptionInterventions
Part A: LY2880070ExperimentalMultiple oral doses of LY2880070 during 21-day cycles
  • LY2880070
Part A: LY2880070 with GemcitabineExperimentalMultiple oral doses of LY2880070, and Gemcitabine administered intravenously during 21-day cycles
  • LY2880070
  • Gemcitabine
Part A: LY2880070 (Metabolism Phenotype)ExperimentalMultiple oral doses of LY2880070 administered during 21 day cycles, to participants who are poor metabolizers
  • LY2880070
Part B: LY2880070 and Gemcitabine (Breast)ExperimentalMultiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
  • LY2880070
  • Gemcitabine
Part B: LY2880070 and Gemcitabine (Colorectal)ExperimentalMultiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
  • LY2880070
  • Gemcitabine
Part B:LY2880070 and Gemcitabine (Ovarian)ExperimentalMultiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
  • LY2880070
  • Gemcitabine
Part B: LY2880070 and Gemcitabine (Endometrial)ExperimentalMultiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
  • LY2880070
  • Gemcitabine
Part B: LY2880070 and Gemcitabine (Soft Tissue Sarcoma (STS))ExperimentalMultiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
  • LY2880070
  • Gemcitabine
Part B: LY2880070 and Gemcitabine (Pancreatic)ExperimentalMultiple oral doses of LY2880070 during 21-day cycles with Gemcitabine (administered intravenously)
  • LY2880070
  • Gemcitabine

Eligibility Criteria

        Inclusion Criteria:

          -  Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
             scale

          -  Have an estimated life expectancy of greater than or equal to (≥)12 weeks

          -  Have adequate organ function

          -  Have received 1-4 prior systemic therapies for locally advanced or metastatic disease

          -  Agree to use medically approved contraceptives during the study and for 3 months
             following the last study treatment

          -  All females must have a negative serum pregnancy test result, and females of
             child-bearing potential must have a negative urine pregnancy test result, prior to the
             first study treatment

          -  Have tumor lesions considered measurable by the Response Evaluation Criteria in Solid
             Tumors (RECIST) v1.1

          -  Must be, in the judgment of the investigator, an appropriate candidate for
             experimental therapy, and no standard therapy would confer clinical benefit

        For Part A

          -  Must have evidence of cancer (solid tumors, excluding glioblastoma and primary brain
             tumor) that is advanced or metastatic

          -  For the Metabolism Phenotype Arm in Part A, participants must have a Cytochrome P450
             (CYP2D6) poor metabolizer phenotype

        For Part B

          -  Have advanced or metastatic colorectal cancer, triple negative breast cancer (per
             American Society of Clinical Oncology-College of American Pathology guidelines),
             epithelial ovarian cancer, endometrial, soft tissue sarcoma, pancreatic cancer

               -  For TNBC:

                    -  Recurrent/refractory Triple Negative Breast Cancer (TNBC) defined as any
                       beast cancer that expresses <1% estrogen receptor (ER) and <1% progesterone
                       receptor (PR) and is Her2 negative

               -  For Colorectal (CRC):

                    -  Must have histologically confirmed advanced or metastatic colorectal cancer

               -  For Ovarian Cancer:

                    -  Must have histologically confirmed advanced or metastatic epithelial ovarian
                       cancer

                    -  Must be eligible to receive Gemzar (GEM) and not refractory to
                       GEM/carboplatin

                    -  Must have the ability to tolerate GEM

                    -  May have received GEM as previous therapy

               -  For Endometrial cancer:

                    -  Must have histologically confirmed endometrial cancer that is metastatic or
                       locally advanced

                    -  Must have failed at least 1 prior chemotherapy

               -  For STS:

                    -  Must have histologically confirmed STS that is metastatic or locally
                       advanced

                    -  Patients with gastrointestinal stromal tumors (GIST) must have failed a KIT
                       inhibitor

                    -  Must have failed at least 1 prior chemotherapy

               -  For Pancreatic Cancer:

                    -  Must have histologically confirmed pancreatic cancer that is metastatic or
                       locally advanced

                    -  Must have failed at least 1 prior chemotherapy regimen

        Exclusion Criteria:

          -  Have received treatment with an investigational drug which has not received regulatory
             approval within 21 days of first study treatment

          -  Have symptomatic central nervous system (CNS) metastasis

          -  Females who are pregnant or nursing

          -  Have known positive test results of human immunodeficiency virus, or have chronic
             active hepatitis A, B or C

          -  Have a corrected QT interval (QTcB) greater than (>) 470 milliseconds (msec) (female)
             or >450 msec (male), or a history of congenital long QT syndrome

          -  Have had a bone marrow transplant

          -  Have participated in this study, or are currently enrolled in another clinical study
             of an investigational medicinal product

          -  Have had radiation therapy to >25% of bone marrow

          -  For Part B

               -  Have a history of another active cancer within the past year, except cervical
                  cancer in situ, in situ carcinoma of the bladder, basal cell carcinoma of the
                  skin, or another in situ carcinoma that is considered cured
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Tolerated Dose(s)
Time Frame:Baseline through Cycle 1 (Estimated up to 21 days)
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Number of dose limiting toxicities (DLTs)
Time Frame:Baseline through Cycle 1 (Estimated up to 21 days)
Safety Issue:
Description:
Measure:Area under the plasma concentration versus time curve from time zero to 24 hours post-dose (AUC0-24)
Time Frame:Baseline to 24-hours post dose (up to Day 20 in Cycle 1)
Safety Issue:
Description:
Measure:Peak plasma concentration (Cmax)
Time Frame:Baseline to 24 hours post-dose (up to Day 20 in Cycle 1)
Safety Issue:
Description:
Measure:Time to reach maximum plasma concentration (tmax)
Time Frame:Baseline to 24 hours post dose (up to Day 20 in Cycle 1)
Safety Issue:
Description:
Measure:Change from baseline in white blood cell count
Time Frame:Baseline to 24 hours post dose (up to Day 20 in Cycle 1)
Safety Issue:
Description:
Measure:Change from baseline in neutrophil count
Time Frame:Baseline to 24 hours post dose (up to Day 20 in Cycle 1)
Safety Issue:
Description:
Measure:Change from baseline in lymphocyte count
Time Frame:Baseline to 24 hours post dose (up to Day 20 in Cycle 1)
Safety Issue:
Description:
Measure:Number of participants with tumor response (objective response rate) as measured by the Response Evaluable Criteria in Solid Tumors (RECIST v.1.1)
Time Frame:Baseline to study completion (estimated up to 4 years)
Safety Issue:
Description:
Measure:Duration of objective response
Time Frame:Baseline to study completion (estimated up to 4 years)
Safety Issue:
Description:
Measure:Best response
Time Frame:Baseline to study completion (estimated up to 4 years)
Safety Issue:
Description:
Measure:Progression free survival
Time Frame:Baseline to study completion (estimated up to 4 years)
Safety Issue:
Description:
Measure:Overall survival
Time Frame:Baseline up to 1 year
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Esperas Pharma Inc.

Trial Keywords

  • Metastatic cancer
  • Advanced cancer
  • Recurrent cancer
  • Colorectal neoplasms
  • Triple negative breast cancer
  • Ovarian neoplasms
  • Colon neoplasms
  • Rectal neoplasms
  • Triple negative breast neoplasms
  • Gastrointestinal stromal tumor
  • Pancreatic Neoplasms
  • Pancreatic Cancer

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