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A Study of Rebastinib (DCC-2036) in Combination With Carboplatin in Patients With Advanced or Metastatic Solid Tumors

NCT03717415

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.

Related Conditions:
  • Breast Carcinoma
  • Malignant Pleural Mesothelioma
  • Malignant Solid Tumor
  • Ovarian Carcinoma
  • Peritoneal Mesothelioma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
rebastinibDCC-2036Part 1
CarboplatinPart 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

NameTypeDescriptionInterventions
Part 1ExperimentalDose 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
  • rebastinib
  • Carboplatin
Part 2ExperimentalDose expansion in the following tumor types at the recommended Phase 2 dose (RP2D) of rebastinib in combination with carboplatin Triple-negative breast cancer Ovarian cancer Mesothelioma
  • rebastinib
  • Carboplatin

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 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:Recruiting
Lead Sponsor:Deciphera Pharmaceuticals LLC

Trial Keywords

  • rebastinib
  • breast cancer
  • ovarian cancer
  • mesothelioma

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