Study to Evaluate the Efficacy and Safety of TT-00420 (Tinengotinib) in Cholangiocarcinoma
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ClinicalTrials.gov Identifier: NCT04919642 |
Recruitment Status :
Completed
First Posted : June 9, 2021
Last Update Posted : April 26, 2024
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Sponsor:
TransThera Sciences (Nanjing), Inc.
Information provided by (Responsible Party):
TransThera Sciences (Nanjing), Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | May 27, 2021 | ||||
First Posted Date ICMJE | June 9, 2021 | ||||
Last Update Posted Date | April 26, 2024 | ||||
Actual Study Start Date ICMJE | December 7, 2021 | ||||
Actual Primary Completion Date | February 28, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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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 |
Genetic Alteration Status [ Time Frame: Through study completion, an average of 9 months ] Evaluation of biomarkers, including but not limited to, FGFR mutation status
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study to Evaluate the Efficacy and Safety of TT-00420 (Tinengotinib) in Cholangiocarcinoma | ||||
Official Title ICMJE | A Phase II, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of TT-00420 (Tinengotinib) Tablet in Adult Patients With Advanced Cholangiocarcinoma | ||||
Brief Summary | This study is an open-label, multicenter study to evaluate the efficacy and safety of TT-00420 tablet in adult patients with advanced cholangiocarcinoma. | ||||
Detailed Description | This is a Phase II, open-label study to evaluate the efficacy and safety of TT00420 in patients with advanced/metastatic and surgically unresectable cholangiocarcinoma (CCA) with 1) FGFR 2 fusions who failed prior FGFR inhibitor treatment, 2) FGFR2 fusions who responded on prior FGFR inhibitor treatment, 3) with other FGFR alterations, or 4) whose tumors do not contain a detectable FGFR alteration. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: TT-00420
TT-00420 tablet, administered orally once daily
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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 |
55 | ||||
Original Estimated Enrollment ICMJE |
80 | ||||
Actual Study Completion Date ICMJE | February 28, 2024 | ||||
Actual Primary Completion Date | February 28, 2024 (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 | NCT04919642 | ||||
Other Study ID Numbers ICMJE | TT420C1206 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | TransThera Sciences (Nanjing), Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | TransThera Sciences (Nanjing), Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | TransThera Sciences (Nanjing), Inc. | ||||
Verification Date | December 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |