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A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02950064
Recruitment Status : Active, not recruiting
First Posted : October 31, 2016
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Placon Therapeutics

Tracking Information
First Submitted Date  ICMJE October 5, 2016
First Posted Date  ICMJE October 31, 2016
Last Update Posted Date January 14, 2019
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2016)
  • Part 1 - Maximum tolerated dose (MTD) of BTP-114 determined during the dose escalation phase of study based on number of patients experiencing a dose-limiting toxicity. [ Time Frame: From the date of the first dose up to approximately 52 weeks. ]
  • Part 1 - Recommended Phase 2 Dose (RP2D) of BTP-114 based on the MTD, review of adverse event data and review of AUC, Tmax and t1/2 obtained from PK data during the dose escalation phase of the study. [ Time Frame: From the date of the first dose up to approximately 52 weeks. ]
  • Part 1 - Number of patients experiencing treatment-related adverse events as assessed by CTCAE v4.3 during the study. [ Time Frame: From the date of first dose up to approximately 52 weeks. ]
  • Part 2 - Proportion of patients with an objective response (ORR) using the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 or the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria. [ Time Frame: From the date of the first dose to documented disease progression assessed up to approximately 52 weeks. ]
  • Part 2 - Proportion of patients whose disease is controlled (DCR) using RECIST, Version 1.1 or PCWG2 criteria. [ Time Frame: From the date of the first dose to documented disease progression assessed up to approximately 52 weeks. ]
  • Part 2 - Duration of response (DOR) measured from the date of first CR or PR until the first date of progressive disease or death from any cause. [ Time Frame: Assessed up to approximately 52 weeks. ]
  • Part 2 - Progression-free survival (PFS) measured as the time from the date of initiation of BTP-114 treatment to the documented disease progression (PD) or death from any cause. [ Time Frame: Assessed up to approximately 52 weeks. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: October 28, 2016)
  • Part 1 - Proportion of patients with an objective response (ORR) using the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 or the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria. [ Time Frame: From the date of the first dose to documented disease progression assessed up to approximately 52 weeks. ]
  • Part 1 - Proportion of patients whose disease is controlled (DCR) using RECIST, Version 1.1 or PCWG2 criteria. [ Time Frame: From the date of the first dose to documented disease progression assessed up to approximately 52 weeks. ]
  • Part 1 - Duration of response (DOR) measured from the date of first CR or PR until the first date of progressive disease or death from any cause. [ Time Frame: Assessed up to approximately 52 weeks. ]
  • Part 1 - Progression-free survival (PFS) measured as the time from the date of initiation of BTP-114 treatment to the documented disease progression (PD) or death from any cause. [ Time Frame: Assessed up to approximately 52 weeks. ]
  • Part 1 - Plasma Pharmacokinetics (PK) estimates of platinum concentration, Area under plasma Concentration (AUC) 0 to t. [ Time Frame: Time points on Day 1, Day 3 or Day 4, Day 15 of Cycle 1 and Day 1 of subsequent cycles. ]
  • Part 1 - Plasma Pharmacokinetics (PK) estimates of platinum concentration, time of Maximum concentration (Tmax). [ Time Frame: Time points on Day 1, Day 3 or Day 4, Day 15 of Cycle 1 and Day 1 of subsequent cycles. ]
  • Part 1 - Plasma Pharmacokinetics (PK) estimates of platinum concentration Half-life (T1/2). [ Time Frame: Time points on Day 1, Day 3 or Day 4, Day 15 of Cycle 1 and Day 1 of subsequent cycles ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations
Official Title  ICMJE Escalation Study of BTP-114 in Patients With Advanced Solid Tumors and BRCA or DNA Repair Mutation
Brief Summary This is a phase 1, Open-label, multicenter Dose Escalation study of BTP-114, a novel platinum product, in patients with advanced solid tumors and BRCA or other DNA repair mutation. This clinical study is comprised of 2 sequential parts: Part 1 (Dose Escalation) and Part 2 (Expansion). The purpose of this study is to evaluate the safety, pharmacokinetics and the anti-cancer activity of BTP-114.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pancreatic Neoplasms
  • Ovarian Neoplasms
  • Breast Neoplasms
  • Prostatic Neoplasms
Intervention  ICMJE Drug: BTP-114

Part 1 (Escalation) IV treatment of BTP-114 in 21-day cycles. Doses will be increased in sequential cohorts until the maximum tolerated dose is determined which will lead to the recommended phase 2 dose

Part 2 (Expansion) 5 cohorts of patients will be treated at the RP2D of IV BTP-114 in 21-day cycles for the tumor types pancreatic cancer, castration-resistant prostate cancer, ovarian cancer, triple-negative breast cancer and deoxyribonucleic acid (DNA) repair mutation-positive advanced solid tumors.

Study Arms  ICMJE Experimental: BTP-114
Intravenous (IV) treatment n 21-day cycles
Intervention: Drug: BTP-114
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 28, 2016)
95
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

INCLUSION:

All Patients

  1. Male or female aged ≥18 years.
  2. ECOG PS score of 0-1.
  3. Adequate organ function.
  4. Ability to understand and willingness to sign informed consent form prior to initiation of study procedures.
  5. Measurable disease per RECIST, OR for patients with a primary diagnosis of castration resistant prostate cancer, progressive disease (PD) by prostate surface antigen (PSA) or imaging in the setting of medical or surgical castration.
  6. Documented BRCA mutation, with the following exceptions: a) Patient is intended to be enrolled in a Single-patient Cohort; b) Patient has an advanced DNA repair mutation-positive solid tumor and is intended to be enrolled in Expansion Cohort 5.

    Patients in the Dose-escalation Phase:

  7. Locally advanced solid tumor other than a primary central nervous system (CNS) tumor for which the patient has received ≤3 prior lines
  8. Confirmed solid tumor in one of the following categories:

    • BRCA mutation-positive pancreatic cancer for which the patient received up to 1 prior line of cytotoxic chemotherapy in the advanced disease setting.
    • Advanced BRCA mutation-positive castration-resistant prostate cancer (CRPC) for which the patient received up to 2 prior lines of cytotoxic chemotherapy in the advanced disease setting.
    • Advanced BRCA mutation-positive ovarian cancer for which the patient received up to 3 prior lines of cytotoxic chemotherapy in the advanced disease setting.
    • Advanced BRCA mutation-positive triple-negative breast cancer (TNBC) for which the patient received up to 3 prior lines of cytotoxic chemotherapy in the advanced disease setting.
    • Advanced DNA repair mutation-positive solid tumors, including, but not limited to BRCA and non-BRCA DNA mutations, who have received up to 3 prior lines of cytotoxic chemotherapy in the advanced disease setting. DNA-repair mutations may include, but are not limited to ATM, CHEK2, PALB2, and RAD51D. Abnormal homologous repair deficiency (HRD) tests will also be allowed.

Note that in both dose escalation and dose expansion portions of the study, prior targeted therapy including prior poly ADP ribose polymerase (PARP) inhibitor therapy, prior immunotherapy, or prior hormonal therapy is permissible. Patients with castration resistant prostate cancer may have received unlimited prior hormonal therapies.

EXCLUSION:

  1. History of leptomeningeal disease or spinal cord compression.
  2. Underwent major surgery within 4 weeks before first treatment.
  3. Received cancer-directed therapy 14 days (6 weeks for mitomycin C and nitrosoureas) before start of treatment.
  4. Grade 2 or greater peripheral neuropathy at start of treatment.
  5. If female, pregnant or breast-feeding.
  6. Known human immunodeficiency virus (HIV) infection or hepatitis B or C infection
  7. Any primary brain tumor (e.g., astrocytoma, glioblastoma).
  8. Hypersensitivity or history of anaphylactic reaction to any platinum-containing agents.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02950064
Other Study ID Numbers  ICMJE BTP-114-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Placon Therapeutics
Study Sponsor  ICMJE Placon Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Erika P Hamilton, MD Tennessee Oncology, PLLC
PRS Account Placon Therapeutics
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP