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A Phase 1 Study Evaluating the Safety, PK, and Clinical Effects of PT-112 in Subjects With Advanced Solid Tumors

NCT02266745

Description:

This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be conducted in two parts: the Dose Escalation Phase and the Dose Expansion Phase. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose(s) (RP2D) of PT-112 Injection and evaluate its safety and tolerability, and PK (pharmacokinetics). The Dose Escalation Phase and is no longer enrolling. The Dose Expansion Phase currently has two cohorts: one for the study of PT-112 in patients with thymoma and thymic carcinoma, and the second in the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC). Condition or disease: Advanced Solid Tumors; Thymoma and Thymic Carcinoma; Metastatic Castrate Resistant Prostate Cancer (mCRPC) Intervention/treatment: Drug: PT-112 Injection Phase: Phase 1/2

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Phase 1 Study Evaluating the Safety, PK, and Clinical Effects of PT-112 in Subjects With Advanced Solid Tumors
  • Official Title: A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: PT-112-101
  • NCT ID: NCT02266745

Conditions

  • Advanced Solid Tumors
  • TET: Thymic Epithelia Tumors
  • CRPC
  • mCRPC
  • Metastatic Castrate-resistant Prostate Cancer
  • PT-112
  • Prostatic Neoplasms
  • Genital Neoplasms, Male
  • Urogenital Neoplasms
  • Neoplasms by Site

Interventions

DrugSynonymsArms
PT-112 InjectionPT-112PT-112 injection

Purpose

This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be conducted in two parts: the Dose Escalation Phase and the Dose Expansion Phase. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose(s) (RP2D) of PT-112 Injection and evaluate its safety and tolerability, and PK (pharmacokinetics). The Dose Escalation Phase and is no longer enrolling. The Dose Expansion Phase currently has two cohorts: one for the study of PT-112 in patients with thymoma and thymic carcinoma, and the second in the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC). Condition or disease: Advanced Solid Tumors; Thymoma and Thymic Carcinoma; Metastatic Castrate Resistant Prostate Cancer (mCRPC) Intervention/treatment: Drug: PT-112 Injection Phase: Phase 1/2

Detailed Description

      This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be
      conducted in two parts: the Dose Escalation Phase, and the Dose Expansion Phase

      The Dose Escalation Phase is no longer enrolling. The Dose Expansion Phase is commencing in
      the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC).
    

Trial Arms

NameTypeDescriptionInterventions
PT-112 injectionExperimentalPT-112 Injection, administered by intravenous infusion
  • PT-112 Injection

Eligibility Criteria

        Key Inclusion Criteria:

          -  Pathologically confirmed advanced solid tumor for which standard therapy proven to
             provide clinical benefit does not exist or is no longer effective.

          -  Eastern Collaborative Oncology Group (ECOG) Performance Status of 0-1.

          -  Progressive disease, either measurable on physical examination or imaging by Response
             Evaluation Criteria in Solid Tumors (RECIST v1.1) or PCWG3 or by informative tumor
             marker(s).

          -  Adequate organ function based on laboratory values.

          -  If there is a known history of brain metastases, either treated or untreated, the
             disease must be stable.

          -  Willing and able to provide written Informed Consent and comply with the requirements
             of the study.

        Key Exclusion Criteria:

          -  Any cytotoxic chemotherapy within 21 days prior to initiation of study drug.

          -  Any immunomodulatory drug therapy, anti-neoplastic hormonal therapy, immunosuppressive
             therapy, corticosteroids, or growth factor treatment within 14 days prior to
             initiation of study drug.

          -  Presence of an acute or chronic toxicity of prior chemotherapy, that has not resolved
             to ≤Grade 1, as determined by CTCAE v 4.0.

          -  Receipt of more than 3 prior regimens of cytotoxic chemotherapy for metastatic
             disease.

          -  Bone marrow reserve which is not adequate for participation in this trial.

          -  Radiotherapy within 28 days prior to baseline.

          -  Fraction of radiotherapy to >25 % of bone marrow.

          -  Major surgery within 28 days prior to initiation of study drug.

          -  Active bacterial, viral, or fungal infection requiring systemic therapy.

          -  Known human immunodeficiency virus or acquired immunodeficiency syndrome related
             illness.

          -  Clinically significant hearing impairment, as judged by the Principal Investigator.

          -  Uncontrolled cardiovascular abnormalities.

          -  Previous malignancy, except for non-squamous-cell carcinoma of skin or carcinoma
             in-situ of the uterine cervix, unless the tumor was treated with curative intent more
             than 2 years prior to study entry.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Determine the safety and tolerability, Dose Limiting Toxicity(ies) (DLT), Maximum Tolerated Dose (MTD), and recommended Phase 2 dose(s) (RP2D)
Time Frame:28-day cycle
Safety Issue:
Description:The primary endpoint is to determine the safety profile and MTD of PT-112 Injection. Assessments will include drug exposure; characterization of DLTs; characterization of the type, incidence, severity, seriousness, and relationship to treatment of adverse events (AEs), and effects on vital signs and laboratory parameters.

Secondary Outcome Measures

Measure:Document any observed anti-tumor effects
Time Frame:Day 1, Day 56 and every 56 days subsequently
Safety Issue:
Description:Subjects will be assessed for clinical activity of PT-112 Injection every 2 cycles by appropriate physical examination or computed tomography imaging techniques, using RECIST v1.1; and, where appropriate, informative tumor markers every cycle.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Phosplatin Therapeutics

Trial Keywords

  • PT-112

Last Updated

October 22, 2020