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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Sep 2016

Longer than P75 for phase_1

Geographic Reach

1 country

8 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.9 years study duration

Study Start

First participant enrolled

September 1, 2016

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

October 5, 2016

Completed

26 days until next milestone

First Posted

Study publicly available on registry

October 31, 2016

Completed

3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed

Last Updated

January 14, 2019

Status Verified

January 1, 2019

Enrollment Period

3.6 years

First QC Date

October 5, 2016

Last Update Submit

January 11, 2019

Conditions

Pancreatic Neoplasms Ovarian Neoplasms Breast Neoplasms Prostatic Neoplasms

Keywords

BRCABRCA1BRCA2Pancreatic cancerOvarian cancerCastrate resistant prostate cancerTriple negative breast cancerBreast cancerDNA repair mutation-positive solid tumors

Outcome Measures

Primary Outcomes (7)

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.
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.
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.
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.
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.
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.
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.
Assessed up to approximately 52 weeks.

Other Outcomes (7)

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.
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.
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.
Assessed up to approximately 52 weeks.
+4 more other outcomes

Study Arms (1)

BTP-114

EXPERIMENTAL

Intravenous (IV) treatment n 21-day cycles

Drug: BTP-114

Interventions

BTP-114DRUG

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.

BTP-114

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

All Patients
Male or female aged ≥18 years.
ECOG PS score of 0-1.
Adequate organ function.
Ability to understand and willingness to sign informed consent form prior to initiation of study procedures.
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.
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:
Locally advanced solid tumor other than a primary central nervous system (CNS) tumor for which the patient has received ≤3 prior lines
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.
+1 more criteria

You may not qualify if:

History of leptomeningeal disease or spinal cord compression.
Underwent major surgery within 4 weeks before first treatment.
Received cancer-directed therapy 14 days (6 weeks for mitomycin C and nitrosoureas) before start of treatment.
Grade 2 or greater peripheral neuropathy at start of treatment.
If female, pregnant or breast-feeding.
Known human immunodeficiency virus (HIV) infection or hepatitis B or C infection
Any primary brain tumor (e.g., astrocytoma, glioblastoma).
Hypersensitivity or history of anaphylactic reaction to any platinum-containing agents.

Contact the study team to confirm eligibility.