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 Genders
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
  4. Triple-negative and Stage IV inflammatory breast cancer.
  5. Recurrent ovarian cancer.
  6. Recurrent, metastatic or high-risk endometrial cancer.
  7. ECOG PS of ≤2.
  8. Able to provide an archival tumor tissue sample
  9. Adequate organ function and bone marrow reserve
  10. If a female of childbearing potential, must have a negative pregnancy test prior to enrollment.
  11. 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

Study Design

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

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1
Dose 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.
  • Drug: rebastinib
    25 mg tablets or 75 mg tablets
    Other names:
    • DCC-2036
  • Drug: Paclitaxel
    Paclitaxel administered by IV infusion at 80 mg/m2
Experimental
Part 2
Dose 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
  • Drug: rebastinib
    25 mg tablets or 75 mg tablets
    Other names:
    • DCC-2036
  • Drug: Paclitaxel
    Paclitaxel administered by IV infusion at 80 mg/m2

Recruiting Locations

Montefiore-Einstein Center for Cancer Care
Bronx, New York 10461
Contact:
Sanjay Goel

More Details

NCT ID
NCT03601897
Status
Recruiting
Sponsor
Deciphera Pharmaceuticals LLC

Study Contact

Clinical Trials
785-830-2100
clinicaltrials@deciphera.com

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.