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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

Sponsor
Deciphera Pharmaceuticals LLC (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03601897
Collaborator
(none)
201
Enrollment
14
Locations
2
Arms
48.4
Anticipated Duration (Months)
14.4
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
201 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 19, 2018
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1 - Completed

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 Gynecological Carcinosarcoma

    Drug: rebastinib
    25 mg tablets or 75 mg tablets
    Other Names:
  • DCC-2036

    • Drug: Paclitaxel
    Paclitaxel administered by IV infusion at 80 mg/m2

    Outcome Measures

    Primary Outcome Measures

    1. Adverse Events (Part 1 and Part 2) [Approximately 36 months]

    2. Objective response rate (ORR) (Part 2) [Approximately 36 months]

    Secondary Outcome Measures

    1. Maximum observed concentration (Cmax) of rebastinib [Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days)]

      Measure the Cmax

    2. Area under the concentration-time curve (AUC) of rebastinib [Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days)]

      Measure the AUC

    3. Progression-free-survival (PFS) [Approximately 36 months]

      Measure of the time from Cycle 1 Day 1 to disease progression or death due to any cause

    4. Time to progression (TTP) [Approximately 36 months]

      Measure of the time from Cycle 1 Day 1 to the first documentation of progressive disease

    5. Duration of response (DOR) [Approximately 36 months]

      Measure of time from PR, CR to disease progression or death due to any cause

    6. Overall survival (OS) [Approximately 36 months]

      Measure of overall survival

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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

    1. ECOG PS of ≤2.

    2. Able to provide an archival tumor tissue sample

    3. Adequate organ function and bone marrow reserve

    4. If a female of childbearing potential, must have a negative pregnancy test prior to enrollment.

    5. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama Comprehensive Cancer Center Birmingham Alabama United States 35233
    2 University of Colorado Denver- Anschutz Medical Center Aurora Colorado United States 80045
    3 Northwestern University Feinberg School of Medicine Chicago Illinois United States 60611
    4 The University of Kansas Clinical Research Center Kansas City Kansas United States 66160
    5 Dana-Farber Boston Massachusetts United States 02215
    6 Montefiore Medical Center Bronx New York United States 10467
    7 Northwell Health/Monter Cancer Center Lake Success New York United States 11042
    8 Ohio State University Wexner Medical Center Columbus Ohio United States 43210
    9 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    10 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    11 Women & Infants Hospital Providence Rhode Island United States 02905
    12 Sarah Cannon Research Institute Nashville Tennessee United States 37203
    13 MD Anderson Cancer Center Houston Texas United States 77030
    14 Oncology Consultants- Texas Medical Center Houston Texas United States 77030

    Sponsors and Collaborators

    • Deciphera Pharmaceuticals LLC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Deciphera Pharmaceuticals LLC
    ClinicalTrials.gov Identifier:
    NCT03601897
    Other Study ID Numbers:
    • DCC-2036-01-003
    First Posted:
    Jul 26, 2018
    Last Update Posted:
    Sep 30, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Deciphera Pharmaceuticals LLC
    rebastinib
    paclitaxel
    breast cancer
    ovarian cancer
    endometrial cancer
    gynecological carcinosarcoma
    malignant mixed Mullerian tumor (MMMT)
    Additional relevant MeSH terms:
    Neoplasms
    Paclitaxel
    Rebastinib

    Study Results

    No Results Posted as of Sep 30, 2021