Pancreatic NeoplasmsPhase 1NCT02950064
A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations
A Phase 1 study testing BTP-114 in people with Pancreatic Neoplasms and Ovarian Neoplasms, run by Placon Therapeutics at 8 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms, Ovarian Neoplasms, Breast Neoplasms
- What is being tested?
- BTP-114
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 8 sitesUnited States
- Study dates
- Sep 2016to Aug 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Placon Therapeutics Clinical Trial Site
Boston, Massachusetts, 02114
Placon Therapeutics Clinical Trial Site
Boston, Massachusetts, 02215
Placon Therapeutics Clinical Trial Site
Cleveland, Ohio, 44106
Placon Therapeutics Clinical Trial Site
Houston, Texas, 77030
Placon Therapeutics Clinical Trial Site
Nashville, Tennessee, 37203
Placon Therapeutics Clinical Trial Site
Oklahoma City, Oklahoma, 73104
Placon Therapeutics Clinical Trial Site
Sarasota, Florida, 34232
Placon Therapeutics Clinical Trial Site
St Louis, Missouri, 63110
About this study
Official title: Escalation Study of BTP-114 in Patients With Advanced Solid Tumors and BRCA or DNA Repair Mutation
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.
- Being tested
- BTP-114
- Keywords
- BRCA, BRCA1, BRCA2, Pancreatic cancer, Ovarian cancer, Castrate resistant prostate cancer, Triple negative breast cancer, Breast cancer, DNA repair mutation-positive solid tumors
- Medical subject headings
- Pancreatic Neoplasms, Ovarian Neoplasms, Breast Neoplasms, Prostatic Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| BTP-114 | Experimental | Intravenous (IV) treatment n 21-day cycles Receives: Drug: BTP-114 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed up to approximately 52 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionApr 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Placon Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erika P Hamilton, MD, Principal investigator, Tennessee Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950064
- Sponsor's protocol ID
- BTP-114-001
- Status last verified
- Jan 2019
- First submitted
- 5 Oct 2016
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Escalation Study of BTP-114 in Patients With Advanced Solid Tumors and BRCA or DNA Repair Mutation
- ClinicalTrials.gov ID
- NCT02950064
- Acronym / sponsor ID
- BTP-114-001
- Keywords
- BRCA, BRCA1, BRCA2, Pancreatic cancer, Ovarian cancer, Castrate resistant prostate cancer, Triple negative breast cancer, Breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Placon TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BTP-114 | Experimental | Drug: BTP-114Intravenous (IV) treatment n 21-day cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BTP-114Part 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. | Drug | BTP-114 |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erika P Hamilton, MD principal investigator
Tennessee Oncology
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BTP-114 in people with Pancreatic Neoplasms and Ovarian Neoplasms, run by Placon Therapeutics at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019.