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Trial record 2 of 4 for:    Rebastinib

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

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ClinicalTrials.gov Identifier: NCT03717415
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Deciphera Pharmaceuticals LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Locally Advanced or Metastatic Solid Tumor Drug: rebastinib Drug: Carboplatin Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 117 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 Carboplatin to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced or Metastatic Solid Tumors
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2020


Arm Intervention/treatment
Experimental: Part 1
Dose 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
Drug: rebastinib
25 mg tablets or 75 mg tablets
Other Name: DCC-2036

Drug: Carboplatin
Carboplatin administered by IV infusion at AUC5 or AUC6

Experimental: Part 2

Dose 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
Drug: rebastinib
25 mg tablets or 75 mg tablets
Other Name: DCC-2036

Drug: Carboplatin
Carboplatin administered by IV infusion at AUC5 or AUC6




Primary Outcome Measures :
  1. Adverse Events (Part 1 and Part 2) [ Time Frame: Approximately 24 months ]
  2. Objective response rate (ORR) (Part 2) [ Time Frame: Approximately 24 months ]

Secondary Outcome Measures :
  1. Maximum observed concentration (Cmax) of rebastinib [ Time Frame: Cycle 1 Day 1, Cycle 2 Day 1 (each cycle is 21 days) ]
    Measure the Cmax

  2. Area under the concentration-time curve (AUC) of rebastinib [ Time Frame: Cycle 1 Day 1, Cycle 2 Day 1 (each cycle is 21 days) ]
    Measure the AUC

  3. Progression-free-survival (PFS) [ Time Frame: Approximately 24 months ]
    Measure of the time from Cycle 1 Day 1 to disease progression or death due to any cause

  4. Time to progression (TTP) [ Time Frame: Approximately 24 months ]
    Measure of the time from Cycle 1 Day 1 to the first documentation of progressive disease

  5. Duration of response (DOR) [ Time Frame: Approximately 24 months ]
    Measure of time from first PR, CR to disease progression or death due to any cause

  6. Overall survival (OS) [ Time Frame: Approximately 24 months ]
    Measure of the interval between Cycle 1 Day 1 until date of death from any cause



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717415


Contacts
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Contact: Clinical Trials 785-830-2100 clinicaltrials@deciphera.com

Locations
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United States, California
University of California San Francisco (UCSF) Recruiting
San Francisco, California, United States, 94115
UCLA Medical Center Recruiting
Santa Monica, California, United States, 90404
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
Deciphera Pharmaceuticals LLC

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Responsible Party: Deciphera Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT03717415     History of Changes
Other Study ID Numbers: DCC-2036-01-004
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
breast cancer
ovarian cancer
mesothelioma
Additional relevant MeSH terms:
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Neoplasms
Carboplatin
Rebastinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action