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Trial record 2 of 3 for:    Rebastinib

A Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel in Patients With Advanced or Metastatic Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03601897
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Deciphera Pharmaceuticals LLC

Tracking Information
First Submitted Date  ICMJE July 5, 2018
First Posted Date  ICMJE July 26, 2018
Last Update Posted Date October 23, 2020
Actual Study Start Date  ICMJE September 19, 2018
Estimated Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2020)
  • Adverse Events (Part 1 and Part 2) [ Time Frame: Approximately 36 months ]
  • Objective response rate (ORR) (Part 2) [ Time Frame: Approximately 36 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 25, 2018)
Incidence of Adverse Events [ Time Frame: Approximately 24 months ]
Identify the observed adverse events, serious adverse events and discontinuation of study drug due to toxicity to inform determination of recommended phase 2 dose
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2020)
  • Maximum observed concentration (Cmax) of rebastinib [ Time Frame: Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days) ]
    Measure the Cmax
  • Area under the concentration-time curve (AUC) of rebastinib [ Time Frame: Cycle 1 Day 1, Cycle 1 Day 15 (each cycle is 28 days) ]
    Measure the AUC
  • Progression-free-survival (PFS) [ Time Frame: Approximately 36 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 36 months ]
    Measure of the time from Cycle 1 Day 1 to the first documentation of progressive disease
  • Duration of response (DOR) [ Time Frame: Approximately 36 months ]
    Measure of time from PR, CR to disease progression or death due to any cause
  • Overall survival (OS) [ Time Frame: Approximately 36 months ]
    Measure of overall survival
Original Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2018)
  • Time to maximum observed concentration at steady state (Tmax,ss) of rebastinib [ Time Frame: Cycle 1 Day 1 (each cycle is 28 days), Cycle 1 Day 15, ≥ Cycle 2 Day 1 (at the following time points: pre-dose; 1, 2, 4, 6, hours post-dose; and pre- and post- paclitaxel infusion) through study completion ]
    Measure the time to maximum observed concentration at steady state
  • Maximum observed concentration (Cmax) of rebastinib [ Time Frame: Cycle 1 Day 1 (each cycle is 28 days), Cycle 1 Day 15, ≥ Cycle 2 Day 1 (at the following time points: pre-dose; 1, 2, 4, 6, hours post-dose; and pre- and post- paclitaxel infusion) through study completion ]
    Measure the Cmax
  • Maximum observed concentration at steady state of rebastinib [ Time Frame: Cycle 1 Day 1 (each cycle is 28 days), Cycle 1 Day 15, ≥ Cycle 2 Day 1 (at the following time points: pre-dose; 1, 2, 4, 6, hours post-dose; and pre- and post- paclitaxel infusion) through study completion ]
    Measure the maximum observed concentration at steady state
  • Concentration observed at the end of the dosing interval (Cmin) of rebastinib in combination with paclitaxel [ Time Frame: Cycle 1 Day 1 (each cycle is 28 days), Cycle 1 Day 15, ≥ Cycle 2 Day 1 (at the following time points: pre-dose; 1, 2, 4, 6, hours post-dose; and pre- and post- paclitaxel infusion) through study completion ]
    Measure the concentration observed at the end of the dosing interval
  • Concentration observed at the end of the dosing interval at steady state (Cmin, ss) of rebastinib in combination with paclitaxel [ Time Frame: Cycle 1 Day 1 (each cycle is 28 days), Cycle 1 Day 15, ≥ Cycle 2 Day 1 (at the following time points: pre-dose; 1, 2, 4, 6, hours post-dose; and pre- and post- paclitaxel infusion) through study completion ]
    Measure the concentration observed at the end of the dosing interval at steady state
  • Area under the concentration-time curve (AUC) of rebastinib in combination with paclitaxel [ Time Frame: Cycle 1 Day 1 (each cycle is 28 days), Cycle 1 Day 15, ≥ Cycle 2 Day 1 (at the following time points: pre-dose; 1, 2, 4, 6, hours post-dose; and pre- and post- paclitaxel infusion) through study completion ]
    Measure the AUC
  • Half-life (T1/2) of rebastinib in combination with paclitaxel [ Time Frame: Cycle 1 Day 1 (each cycle is 28 days), Cycle 1 Day 15, ≥ Cycle 2 Day 1 (at the following time points: pre-dose; 1, 2, 4, 6, hours post-dose; and pre- and post- paclitaxel infusion) through study completion ]
    Measure the half-life
  • Objective response rate (ORR) [ Time Frame: at 8 weeks of the combination therapy, and in the event of disease progression ]
    Objective response rate as determined by confirmed CR + confirmed PR
  • Disease control rate (DCR) [ Time Frame: at 8 weeks of the combination therapy, and in the event of disease progression ]
    DCR as determined by complete response [CR] + partial response [PR] + stable disease
  • Time to best response [ Time Frame: Approximately 24 months ]
    Measure of time from Cycle 1 Day 1 to PR or CR
  • 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 Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel 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 Paclitaxel 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 paclitaxel 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: Paclitaxel
    Paclitaxel administered by IV infusion at 80 mg/m2
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: rebastinib
    • Drug: Paclitaxel
  • 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
    Interventions:
    • Drug: rebastinib
    • Drug: Paclitaxel
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: March 27, 2020)
201
Original Estimated Enrollment  ICMJE
 (submitted: July 25, 2018)
30
Estimated Study Completion Date  ICMJE November 1, 2021
Estimated Primary Completion Date November 1, 2021   (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 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. 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 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
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 NCT03601897
Other Study ID Numbers  ICMJE DCC-2036-01-003
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 October 2020

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