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

This study is currently recruiting participants.
Verified October 2017 by Placon Therapeutics
Sponsor:
ClinicalTrials.gov Identifier:
NCT02950064
First Posted: October 31, 2016
Last Update Posted: October 17, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Placon Therapeutics
  Purpose
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.

Condition Intervention Phase
Pancreatic Neoplasms Ovarian Neoplasms Breast Neoplasms Prostatic Neoplasms Drug: BTP-114 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Escalation Study of BTP-114 in Patients With Advanced Solid Tumors and BRCA or DNA Repair Mutation

Resource links provided by NLM:


Further study details as provided by Placon Therapeutics:

Primary Outcome Measures:
  • 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. ]

Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 95
Study Start Date: September 2016
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BTP-114
Intravenous (IV) treatment n 21-day cycles
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.


  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02950064


Contacts
Contact: Placon Clinical Information Center clinical.information@placontx.com

Locations
United States, Florida
Placon Therapeutics Clinical Trial Site Recruiting
Sarasota, Florida, United States, 34232
United States, Massachusetts
Placon Therapeutics Clinical Trial Site Recruiting
Boston, Massachusetts, United States, 02114
Placon Therapeutics Clinical Trial Site Recruiting
Boston, Massachusetts, United States, 02215
United States, Missouri
Placon Therapeutics Clinical Trial Site Recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
Placon Therapeutics Clinical Trial Site Withdrawn
New York, New York, United States, 10065
United States, Ohio
Placon Therapeutics Clinical Trial Site Recruiting
Cleveland, Ohio, United States, 44106
United States, Oklahoma
Placon Therapeutics Clinical Trial Site Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Placon Therapeutics Clinical Trial Site Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Placon Therapeutics Clinical Trial Site Recruiting
Houston, Texas, United States, 77030
Contact: Apostolia Tsimberidou, MD, PhD       atsimber@mdanderson.org   
Contact: Kshipra Gharpure, MS       kmgharpure@mdanderson.org   
Sponsors and Collaborators
Placon Therapeutics
Investigators
Principal Investigator: Erika P Hamilton, MD Tennessee Oncology, PLLC
  More Information

Responsible Party: Placon Therapeutics
ClinicalTrials.gov Identifier: NCT02950064     History of Changes
Other Study ID Numbers: BTP-114-001
First Submitted: October 5, 2016
First Posted: October 31, 2016
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Placon Therapeutics:
BRCA
BRCA1
BRCA2
Pancreatic cancer
Ovarian cancer
Castrate resistant prostate cancer
Triple negative breast cancer
Breast cancer
DNA repair mutation-positive solid tumors

Additional relevant MeSH terms:
Neoplasms
Breast Neoplasms
Prostatic Neoplasms
Pancreatic Neoplasms
Ovarian Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders