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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

Tracking Information
First Submitted Date  ICMJE October 19, 2018
First Posted Date  ICMJE October 24, 2018
Last Update Posted Date September 17, 2019
Actual Study Start Date  ICMJE January 2, 2019
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2018)
  • Adverse Events (Part 1 and Part 2) [ Time Frame: Approximately 24 months ]
  • Objective response rate (ORR) (Part 2) [ Time Frame: Approximately 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03717415 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • Maximum observed concentration (Cmax) of rebastinib [ Time Frame: Cycle 1 Day 1, Cycle 2 Day 1 (each cycle is 21 days) ]
    Measure the Cmax
  • 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
  • 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
  • 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
  • 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
  • Overall survival (OS) [ Time Frame: Approximately 24 months ]
    Measure of the interval between Cycle 1 Day 1 until date of death from any cause
Original Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2018)
  • Maximum observed concentration (Cmax) of rebastinib [ Time Frame: Cycle 1 Day 1, Cycle 2 Day 1 (each cycle is 21 days) ]
    Measure the Cmax
  • 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
  • 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
  • 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
  • Duration of response (DOR) [ Time Frame: Approximately 24 months ]
    Measure of time from PR, CR to disease progression or death due to any cause
  • Overall survival (OS) [ Time Frame: Approximately 24 months ]
    Measure of overall survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Rebastinib (DCC-2036) in Combination With Carboplatin in Patients With Advanced or Metastatic Solid Tumors
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Locally Advanced or Metastatic Solid Tumor
Intervention  ICMJE
  • Drug: rebastinib
    25 mg tablets or 75 mg tablets
    Other Name: DCC-2036
  • Drug: Carboplatin
    Carboplatin administered by IV infusion at AUC5 or AUC6
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: rebastinib
    • Drug: Carboplatin
  • 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
    Interventions:
    • Drug: rebastinib
    • Drug: Carboplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 22, 2018)
117
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2020
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trials 785-830-2100 clinicaltrials@deciphera.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03717415
Other Study ID Numbers  ICMJE DCC-2036-01-004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Deciphera Pharmaceuticals LLC
Study Sponsor  ICMJE Deciphera Pharmaceuticals LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Deciphera Pharmaceuticals LLC
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP