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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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 - Advanced (stage III or IV), or recurrent gynecological carcinosarcoma - Homologous or heterologous type carcinosarcoma (malignant mixed Mullerian tumor [MMMT] allowed 4. Eastern Cooperative Oncology Group Performance Status (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 central nervous system (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. QT interval corrected by Fridericia's formula (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. Human immunodeficiency virus (HIV) or hepatitis C (HCV) infection only if taking medications excluded per protocol, active hepatitis B (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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1 Arm 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 		Dose escalation of rebastinib 50 milligram (mg) twice daily (BID) orally (PO) in combination with paclitaxel administered by intravenous (IV) infusion at 80 mg/meter squared (m^2) on days 1, 8, and 15 of repeated 28-day cycles.
  • Drug: Rebastinib
    Administered orally
    Other names:
    • DCC-2036
  • Drug: Paclitaxel
    Paclitaxel administered by IV infusion at 80 mg/m^2
Experimental
Part 1 Arm 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 		Dose escalation of rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
  • Drug: Rebastinib
    Administered orally
    Other names:
    • DCC-2036
  • Drug: Paclitaxel
    Paclitaxel administered by IV infusion at 80 mg/m^2
Experimental
Part 2 Cohort 1 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 		Dose expansion in triple-negative breast cancer (TNBC). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
  • Drug: Rebastinib
    Administered orally
    Other names:
    • DCC-2036
  • Drug: Paclitaxel
    Paclitaxel administered by IV infusion at 80 mg/m^2
Experimental
Part 2 Cohort 1 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 		Dose expansion in TNBC. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
  • Drug: Rebastinib
    Administered orally
    Other names:
    • DCC-2036
  • Drug: Paclitaxel
    Paclitaxel administered by IV infusion at 80 mg/m^2
Experimental
Part 2 Cohort 2 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 		Dose expansion in inflammatory breast cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
  • Drug: Rebastinib
    Administered orally
    Other names:
    • DCC-2036
  • Drug: Paclitaxel
    Paclitaxel administered by IV infusion at 80 mg/m^2
Experimental
Part 2 Cohort 2 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 		Dose expansion in inflammatory breast cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
  • Drug: Rebastinib
    Administered orally
    Other names:
    • DCC-2036
  • Drug: Paclitaxel
    Paclitaxel administered by IV infusion at 80 mg/m^2
Experimental
Part 2 Cohort 3 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 		Dose expansion in ovarian cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 repeated 28-day cycles.
  • Drug: Rebastinib
    Administered orally
    Other names:
    • DCC-2036
  • Drug: Paclitaxel
    Paclitaxel administered by IV infusion at 80 mg/m^2
Experimental
Part 2 Cohort 3 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 		Dose expansion in ovarian cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
  • Drug: Rebastinib
    Administered orally
    Other names:
    • DCC-2036
  • Drug: Paclitaxel
    Paclitaxel administered by IV infusion at 80 mg/m^2
Experimental
Part 2 Cohort 4 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 		Dose expansion in endometrial cancer. Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
  • Drug: Rebastinib
    Administered orally
    Other names:
    • DCC-2036
  • Drug: Paclitaxel
    Paclitaxel administered by IV infusion at 80 mg/m^2
Experimental
Part 2 Cohort 4 Rebastinib 100 mg + Paclitaxel 80 mg/m^2 		Dose expansion in endometrial cancer. Rebastinib 100 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
  • Drug: Rebastinib
    Administered orally
    Other names:
    • DCC-2036
  • Drug: Paclitaxel
    Paclitaxel administered by IV infusion at 80 mg/m^2
Experimental
Part 2 Cohort 5 Rebastinib 50 mg + Paclitaxel 80 mg/m^2 		Dose expansion in gynecological carcinosarcoma (GCS). Rebastinib 50 mg BID PO in combination with paclitaxel IV infusion at 80 mg/m^2 on days 1, 8, and 15 of repeated 28-day cycles.
  • Drug: Rebastinib
    Administered orally
    Other names:
    • DCC-2036
  • Drug: Paclitaxel
    Paclitaxel administered by IV infusion at 80 mg/m^2

More Details

Status
Terminated
Sponsor
Deciphera Pharmaceuticals, LLC

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.