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A Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel in Patients With Advanced or Metastatic Solid Tumors

NCT03601897

Description:

This is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination with paclitaxel designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in patients with advanced or metastatic solid tumors.

Related Conditions:
  • Breast Carcinoma
  • Cervical Carcinosarcoma
  • Endometrial Carcinoma
  • Malignant Solid Tumor
  • Ovarian Carcinoma
  • Primary Peritoneal Carcinosarcoma
  • Uterine Corpus Carcinosarcoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel 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 Paclitaxel to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced or Metastatic Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: DCC-2036-01-003
  • NCT ID: NCT03601897

Conditions

  • Locally Advanced or Metastatic Solid Tumor

Interventions

DrugSynonymsArms
rebastinibDCC-2036Part 1
PaclitaxelPart 1

Purpose

This is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination with paclitaxel 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) in combination with paclitaxel administered by IV infusion at 80 mg/m2 in repeated 28-day cycles.
  • rebastinib
  • Paclitaxel
Part 2ExperimentalDose expansion in the following tumor types at the recommended Phase 2 dose (RP2D) of rebastinib in combination with paclitaxel Triple-negative and Stage IV inflammatory breast cancer Ovarian cancer Endometrial cancer
  • rebastinib
  • Paclitaxel

Eligibility Criteria

        Inclusion Criteria:

          1. Male or female patients ≥18 years of age at the time of informed consent.

          2. Part 1 Histologically confirmed diagnosis of a locally advanced or metastatic solid
             tumor for which paclitaxel is considered appropriate treatment.

          3. Part 2

               -  Triple-negative and Stage IV inflammatory breast cancer.

               -  Recurrent ovarian cancer.

               -  Recurrent, metastatic or high-risk endometrial cancer.

          4. ECOG PS 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 prior to the first dose.

          2. Not recovered from prior-treatment toxicities to Grade ≤1.

          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. Venous thrombotic event.

         13. Active infection ≥Grade 3.

         14. 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 1 Day 15 (each cycle is 28 days)
Safety Issue:
Description:Measure the Cmax
Measure:Area under the concentration-time curve (AUC) of rebastinib
Time Frame:Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 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 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 overall survival

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Deciphera Pharmaceuticals LLC

Trial Keywords

  • rebastinib
  • paclitaxel
  • breast cancer
  • ovarian cancer
  • endometrial cancer

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