Study to Evaluate the Efficacy and Safety of TT-00420 (Tinengotinib) in Cholangiocarcinoma (NCT04919642) | Clinical Trial Compass
CompletedPhase 2
Study to Evaluate the Efficacy and Safety of TT-00420 (Tinengotinib) in Cholangiocarcinoma
United States55 participantsStarted 2021-12-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. ≥ 18 years of age, at the time of signing informed consent
✓. 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:
✓. At least one measurable lesion as defined by RECIST V1.1 criteria for solid tumors5
✓. Documentation of FGFR gene alteration status
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
✓. Adequate organ function confirmed at screening and within 10 days of initiating treatment, as evidenced by:
✓. Negative pregnancy test within 72 hours before starting study treatment in all premenopausal women and women \< 12 months after the onset of menopause
✓. Must agree to take sufficient contraceptive methods to avoid pregnancy (including male and female participants) during the study and until at least 6 months after ceasing study treatment
Exclusion criteria
✕. Women who are pregnant or lactating
✕. Women of child-bearing potential (WOCBP) who do not use adequate birth control
✕. Patients with untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed (e.g. evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain/CNS metastases) Note: Patients with treated brain metastases that are off corticosteroids and have been clinically stable for 28 days are eligible for enrollment.
What they're measuring
1
Objective Response Rate (ORR) in patients with FGFR2 fusions who have failed at least one previous treatment with an FGFR inhibitor (Cohort A1)
Timeframe: Through study completion, an average of 9 months.
2
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)
Timeframe: Through study completion, an average of 9 months.
3
ORR in patients with FGFR alterations other than FGFR2 fusions (Cohort B)
Timeframe: Through study completion, an average of 9 months.
4
ORR in patients without FGFR alterations (wild-type FGFR mutation status) (Cohort C)
Timeframe: Through study completion, an average of 9 months.
✕. Patients with a known concurrent malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, carcinoma in situ of the cervix or other noninvasive or indolent malignancy that has previously undergone potentially curative therapy.
✕. 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 uncontrolled hypertension (defined as blood pressure of ≥ 150 mmHg systolic and/or ≥ 90 mmHg diastolic at Screening)