Description:
This is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination
with carboplatin designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in
patients with advanced or metastatic solid tumors.
Title
- Brief Title: A Study of Rebastinib (DCC-2036) in Combination With Carboplatin in Patients With Advanced or Metastatic Solid Tumors
- Official Title: An Open Label, Multicenter, Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Carboplatin to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced or Metastatic Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
DCC-2036-01-004
- NCT ID:
NCT03717415
Conditions
- Locally Advanced or Metastatic Solid Tumor
Interventions
Drug | Synonyms | Arms |
---|
rebastinib | DCC-2036 | Part 1 |
Carboplatin | | Part 1 |
Purpose
This is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination
with carboplatin designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in
patients with advanced or metastatic solid tumors.
Trial Arms
Name | Type | Description | Interventions |
---|
Part 1 | Experimental | Dose comparison between 50 or 100 mg BID of rebastinib orally (PO) dosed in 21-day cycles in combination with carboplatin administered by IV infusion at either AUC5 or AUC6 once every 3 weeks | |
Part 2 | Experimental | Dose expansion in the following tumor types at the recommended Phase 2 dose (RP2D) of rebastinib in combination with carboplatin
Triple-negative breast cancer
Platinum-sensitive Ovarian cancer
Mesothelioma | |
Eligibility Criteria
Inclusion Criteria:
1. Male or female patients ≥18 years of age at the time of informed consent.
2. Part 1 (Dose Escalation). Histologically confirmed diagnosis of a locally advanced or
metastatic solid tumor for which carboplatin is considered appropriate treatment.
3. Part 2 (Dose Expansion)
- Previously treated, triple-negative breast cancer.
- Recurrent platinum-sensitive ovarian cancer.
- Histologically confirmed pleural or peritoneal malignant mesothelioma.
4. ECOG performance status of ≤2.
5. Able to provide an archival tumor tissue sample.
6. Adequate organ function and bone marrow reserve.
7. If a female of childbearing potential, must have a negative pregnancy test prior to
enrollment.
8. Patient must provide signed consent to participate in the study and is willing to
comply with study-specific procedures.
Exclusion Criteria:
1. Received prior anticancer or other investigational therapy within 28 days or 5× the
half-life (whichever is shorter) prior to the first dose.
2. Not recovered from prior-treatment toxicities to Grade ≤1 or baseline.
3. Peripheral neuropathy of any etiology >Grade 1.
4. Concurrent malignancy.
5. Known active CNS metastases.
6. Use of systemic corticosteroids.
7. Known retinal neovascularization, macular edema or macular degeneration.
8. History or presence of clinically relevant cardiovascular abnormalities.
9. QTcF >450 ms in males or >470 ms in females.
10. Left ventricular ejection fraction (LVEF) <50% at screening.
11. Arterial thrombotic or embolic events.
12. Symptomatic venous thrombotic event.
13. Active infection ≥Grade 3.
14. Known HIV or HCV infection only if taking medications excluded per protocol, active
HBV, or active HCV infection.
15. Use of proton pump inhibitors.
16. If female, the patient is pregnant or lactating.
17. Major surgery 4 weeks prior to the first dose of study drug.
18. Malabsorption syndrome or other illness which could affect oral absorption.
19. Known allergy or hypersensitivity to any component of rebastinib or any of its
excipients.
20. Any other clinically significant comorbidities.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Adverse Events (Part 1 and Part 2) |
Time Frame: | Approximately 24 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Maximum observed concentration (Cmax) of rebastinib |
Time Frame: | Cycle 1 Day 1, Cycle 2 Day 1 (each cycle is 21 days) |
Safety Issue: | |
Description: | Measure the Cmax |
Measure: | Area under the concentration-time curve (AUC) of rebastinib |
Time Frame: | Cycle 1 Day 1, Cycle 2 Day 1 (each cycle is 21 days) |
Safety Issue: | |
Description: | Measure the AUC |
Measure: | Progression-free-survival (PFS) |
Time Frame: | Approximately 24 months |
Safety Issue: | |
Description: | Measure of the time from Cycle 1 Day 1 to disease progression or death due to any cause |
Measure: | Time to progression (TTP) |
Time Frame: | Approximately 24 months |
Safety Issue: | |
Description: | Measure of the time from Cycle 1 Day 1 to the first documentation of progressive disease |
Measure: | Duration of response (DOR) |
Time Frame: | Approximately 24 months |
Safety Issue: | |
Description: | Measure of time from first PR, CR to disease progression or death due to any cause |
Measure: | Overall survival (OS) |
Time Frame: | Approximately 24 months |
Safety Issue: | |
Description: | Measure of the interval between Cycle 1 Day 1 until date of death from any cause |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Deciphera Pharmaceuticals LLC |
Trial Keywords
- rebastinib
- breast cancer
- ovarian cancer
- mesothelioma
Last Updated
August 11, 2021