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 :
Completed
First Posted : July 26, 2018
Last Update Posted : September 21, 2023
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Sponsor:
Deciphera Pharmaceuticals LLC
Information provided by (Responsible Party):
Deciphera Pharmaceuticals LLC
Tracking Information | |||||
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First Submitted Date ICMJE | July 5, 2018 | ||||
First Posted Date ICMJE | July 26, 2018 | ||||
Last Update Posted Date | September 21, 2023 | ||||
Actual Study Start Date ICMJE | October 25, 2018 | ||||
Actual Primary Completion Date | May 23, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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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 |
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Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Locally Advanced or Metastatic Solid Tumor | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
177 | ||||
Original Estimated Enrollment ICMJE |
30 | ||||
Actual Study Completion Date ICMJE | May 23, 2022 | ||||
Actual Primary Completion Date | May 23, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
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 |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Deciphera Pharmaceuticals LLC | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Deciphera Pharmaceuticals LLC | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Deciphera Pharmaceuticals LLC | ||||
Verification Date | September 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |