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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BTP-114 | Experimental | Intravenous (IV) treatment n 21-day cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTP-114 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
INCLUSION:
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Erika P Hamilton, MD | Tennessee Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Placon Therapeutics Clinical Trial Site | Sarasota | Florida | 34232 | United States | ||
| Placon Therapeutics Clinical Trial Site |
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|
| Assessed up to approximately 52 weeks. |
| 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. |
| 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. | Assessed up to approximately 52 weeks. |
| Part 1 - Plasma Pharmacokinetics (PK) estimates of platinum concentration, Area under plasma Concentration (AUC) 0 to t. | 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 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 points on Day 1, Day 3 or Day 4, Day 15 of Cycle 1 and Day 1 of subsequent cycles |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Placon Therapeutics Clinical Trial Site | Boston | Massachusetts | 02215 | United States |
| Placon Therapeutics Clinical Trial Site | St Louis | Missouri | 63110 | United States |
| Placon Therapeutics Clinical Trial Site | Cleveland | Ohio | 44106 | United States |
| Placon Therapeutics Clinical Trial Site | Oklahoma City | Oklahoma | 73104 | United States |
| Placon Therapeutics Clinical Trial Site | Nashville | Tennessee | 37203 | United States |
| Placon Therapeutics Clinical Trial Site | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D010051 | Ovarian Neoplasms |
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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