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TT-00420 for Bile Duct Cancer

Phase 2

Waitlist Available

Led By Milind Javle, MD

Research Sponsored by TransThera Sciences (Nanjing), Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

≥ 18 years of age, at the time of signing informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first study drug administration until the date of death from any cause, assessed up to 24 months

Awards & highlights

Study Summary

This trial will study how well TT-00420 works in treating patients with advanced cholangiocarcinoma, as well as assessing its safety.

Who is the study for?

Adults with advanced cholangiocarcinoma (bile duct cancer) who've had prior chemotherapy can join this trial. They must have a certain level of health, confirmed by blood tests and organ function checks, and not be pregnant or breastfeeding. Participants need to use birth control during the study.Check my eligibility

What is being tested?

The trial is testing TT-00420 tablets for safety and effectiveness in treating bile duct cancer. It's an open-label study, meaning everyone knows they're getting the drug, and it involves multiple centers where patients are grouped based on their genetic alterations related to FGFR2.See study design

What are the potential side effects?

While specific side effects of TT-00420 aren't listed here, common ones for cancer treatments include nausea, fatigue, risk of infection due to low blood counts, liver issues shown by blood tests changes, diarrhea or constipation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I am 18 years old or older.

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My blood and organ tests meet the required levels for treatment.

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I have cholangiocarcinoma that can't be removed by surgery and have had chemotherapy.

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My cancer has been tested for FGFR gene changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first study drug administration until the date of death from any cause, assessed up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first study drug administration until the date of death from any cause, assessed up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first study drug administration until the date of death from any cause, assessed up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

ORR in patients with FGFR alterations other than FGFR2 fusions (Cohort B)

ORR in patients with FGFR2 fusions who have responded (CR or PR) on at least one previous treatment with an FGFR inhibitor and discontinued due to progressive disease (Cohort A2)

ORR in patients without FGFR alterations (wild-type FGFR mutation status) (Cohort C)

+1 more

Secondary outcome measures

Concentration of TT-00420 at Protocol-Specified Timepoints (All Cohorts)

Disease Control Rate (DCR) (All Cohorts)

Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment (All Cohorts)

+3 more

Other outcome measures

Genetic Alteration Status

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort CExperimental Treatment1 Intervention

Negative for FGFR alterations (FGFR wild-type)

Group II: Cohort BExperimental Treatment1 Intervention

Other FGFR alterations, including FGFR2 mutations and FGFR1/3 alterations, including fusions

Group III: Cohort A2Experimental Treatment1 Intervention

FGFR2 fusions who have previously responded on at least one previous treatment with an FGFR inhibitor and discontinued due to disease progression

Group IV: Cohort A1Experimental Treatment1 Intervention

FGFR2 fusions who have failed at least one previous treatment with an FGFR inhibitor

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

TransThera Sciences (Nanjing), Inc.Lead Sponsor

13 Previous Clinical Trials

878 Total Patients Enrolled

Milind Javle, MDPrincipal InvestigatorM.D. Anderson Cancer Center

7 Previous Clinical Trials

297 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of individuals involved in this clinical trial?

"Affirmative. Clinicaltrials.gov displays that this research project, initiated on December 7th 2021, is currently accepting applicants. As of now 11 medical centres are recruiting 80 participants for the study."

Answered by AI

Has TT-00420 been accorded official sanction by the FDA?

"The team at Power assigned TT-00420 a safety score of 2, as the clinical trial is in Phase 2. That means there are data points that demonstrate its security but none to prove efficacy."

Answered by AI

Are there any North American healthcare facilities participating in this experimental protocol?

"The current trial is being conducted in Methodist Dallas Medical Center, UT MD Anderson Cancer Centre, New york, Stony Brook University - Long Island Cancer Centre and 11 additional sites."

Answered by AI

Are there still openings for participants in this experiment?

"Affirmative. According to clinicaltrials.gov, this study is currently recruiting patients and has been doing so since December 7th 2021 - the date it was first posted online. Recently updated on November 10th 2022, the trial seeks 80 participants across 11 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate the Efficacy and Safety of TT-00420 (Tinengotinib) in Cholangiocarcinoma

2021. "Study to Evaluate the Efficacy and Safety of TT-00420 (Tinengotinib) in Cholangiocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04919642.

All > Intrahepatic Cholangiocarcinoma > Bile Duct Cancer