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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

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ClinicalTrials.gov Identifier: NCT03601897
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : October 15, 2018
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 paclitaxel 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: Paclitaxel Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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 : September 19, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
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 Name: 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

  • Breast cancer
  • Ovarian cancer
  • Endometrial cancer
Drug: rebastinib
25 mg tablets or 75 mg tablets
Other Name: DCC-2036

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




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 1 Day 15 (each cycle is 28 days) ]
    Measure the Cmax

  2. 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

  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 PR, CR to disease progression or death due to any cause

  6. Overall survival (OS) [ Time Frame: Approximately 24 months ]
    Measure of overall survival



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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 Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor for which paclitaxel or nab-paclitaxel are considered appropriate treatment.
  3. Part 2

    • Previously treated, metastatic breast cancer.
    • Recurrent ovarian cancer.
    • Recurrent, metastatic or high-risk endometrial cancer.
  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 14 days or 5× the half-life (within 28 days for biologics) prior to the first dose.
  2. Not recovered from prior-treatment toxicities to Grade ≤1. Peripheral neuropathy of any etiology >Grade 1.
  3. Concurrent malignancy.
  4. Known active CNS metastases.
  5. Use of systemic corticosteroids.
  6. Known retinal neovascularization, macular edema or macular degeneration.
  7. History or presence of clinically relevant cardiovascular abnormalities.
  8. QTcF >450 ms in males or >470 ms in females.
  9. Left ventricular ejection fraction (LVEF) <50% at screening.
  10. Arterial thrombotic or embolic events.
  11. Venous thrombotic event.
  12. Active infection ≥Grade 3.
  13. HIV or HCV infection only if taking medications excluded per protocol, active HBV, or active HCV infection.
  14. Use of proton pump inhibitors.
  15. If female, the patient is pregnant or lactating.
  16. Major surgery 4 weeks prior to the first dose of study drug
  17. Malabsorption syndrome or other illness which could affect oral absorption.
  18. Known allergy or hypersensitivity to any component of rebastinib or any of its excipients.
  19. 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): NCT03601897


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

Locations
United States, Alabama
University of Alabama Comprehensive Cancer Center Not yet recruiting
Birmingham, Alabama, United States, 35233
United States, New York
Montefiore Medical Center Not yet recruiting
Bronx, New York, United States, 10467
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Fox Chase Cancer Center Not yet recruiting
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Deciphera Pharmaceuticals LLC

Responsible Party: Deciphera Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT03601897     History of Changes
Other Study ID Numbers: DCC-2036-01-003
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
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

Additional relevant MeSH terms:
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action