Condition or disease | Intervention/treatment | Phase |
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Cholangiocarcinoma FGFR2 Fusion FGFR2 Gene Mutation FGFR1 Alteration FGFR3 Alteration | Drug: TT-00420 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of TT-00420 Tablet in Adult Patients With Advanced Cholangiocarcinoma |
Estimated Study Start Date : | October 2021 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | September 2023 |
Arm | Intervention/treatment |
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Experimental: Cohort A1
FGFR2 fusions who have failed at least one previous treatment with an FGFR inhibitor
|
Drug: TT-00420
TT-00420 tablet, administered orally once daily
|
Experimental: Cohort A2
FGFR2 fusions who have previously responded on at least one previous treatment with an FGFR inhibitor and discontinued due to disease progression
|
Drug: TT-00420
TT-00420 tablet, administered orally once daily
|
Experimental: Cohort B
Other FGFR alterations, including FGFR2 mutations and FGFR1/3 alterations, including fusions
|
Drug: TT-00420
TT-00420 tablet, administered orally once daily
|
Experimental: Cohort C
Negative for FGFR alterations (FGFR wild-type)
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Drug: TT-00420
TT-00420 tablet, administered orally once daily
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologically or cytologically documented advanced/metastatic or surgically unresectable cholangiocarcinoma who have received at least one line of prior systemic chemotherapy. Patients will be assigned to 1 of 4 cohorts:
Adequate organ function confirmed at screening and within 10 days of initiating treatment, as evidenced by:
Exclusion Criteria:
Patients with the following mood disorders as judged by the Investigator or a psychiatrist:
Impaired cardiac function or significant diseases, including but not limited to any of the following:
Patients with:
Contact: Peng Peng, Ph.D. | 86-25-86901107 | peng_peng@transtherabio.com | |
Contact: Hui Wang | 86-25-86901159 | wang_hui@transtherabio.com |
United States, California | |
City of Hope | |
Duarte, California, United States, 91010 | |
United States, Texas | |
UT MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Milind Javle, MD | M.D. Anderson Cancer Center |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 27, 2021 | ||||||||
First Posted Date ICMJE | June 9, 2021 | ||||||||
Last Update Posted Date | October 26, 2021 | ||||||||
Estimated Study Start Date ICMJE | October 2021 | ||||||||
Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
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 in Cholangiocarcinoma | ||||||||
Official Title ICMJE | A Phase II, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of TT-00420 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 | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE |
80 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | September 2023 | ||||||||
Estimated Primary Completion Date | December 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 |
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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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Responsible Party | TransThera Sciences (Nanjing), Inc. | ||||||||
Study Sponsor ICMJE | TransThera Sciences (Nanjing), Inc. | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | TransThera Sciences (Nanjing), Inc. | ||||||||
Verification Date | October 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |