Brief Title
Study of TRIFLURIDINE/TIPIRACIL in Previously Treated Cholangiocarcinoma
Official Title
A Multi-Centre, Open-Label Phase 2 Study of TRIFLURIDINE/TIPIRACIL in Previously Treated Cholangiocarcinoma (The MOCHA Trial)
Brief Summary
This is a multi-centre, open-label, single arm phase 2 study to assess the efficacy of
TRIFLURIDINE/TIPIRACIL, in patients with advanced cholangiocarcinoma as measured by median
progression-free survival (PFS).
This study will enroll a total of 47 patients over a 12-month period, according to a two
stage enrollment design. Nine patients will be enrolled during the first stage and the trial
will be terminated if 4 or more out of the 9 have disease progression. If the trial goes on
to the second stage, a total of 47 patients (38 in second stage) will be required.
Patients will be seen prior to enrolment (within 28 days of treatment), every 4 weeks while
on treatment, at the end of treatment, and 30 days post-treatment. Patients will remain on
long-term follow-up and will be seen every 12 weeks (+/- 14 days) until 1 year post-treatment
when they will enter into the survival follow-up period and will be contacted every 12 weeks
by phone until progression or toxicity.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Median progression-free survival (PFS)
Secondary Outcome
Safety and tolerability of FTD/TPI: CTCAE version 5.0
Condition
Cholangiocarcinoma
Intervention
Trifluridine/Tipiracil
Study Arms / Comparison Groups
Trifluridine/Tipiracil
Description: FTD/TPI at 35 mg/m2 (based on BSA) that is administered in tablet form, orally, twice daily, within one hour of morning and evening meals, on days 1-5 and days 8-12 of a 28 day cycle.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
8
Start Date
December 11, 2019
Completion Date
September 30, 2022
Primary Completion Date
September 30, 2022
Eligibility Criteria
Inclusion Criteria:
1. Histologically documented locally advanced or metastatic biliary tract cancer (intra
or extrahepatic cholangiocarcinoma or gallbladder cancer) previously treated with
first line standard chemotherapy (gemcitabine-based chemotherapy at least one cycle).
Patients who develop a recurrence after adjuvant capecitabine therapy must have
subsequently received at least one cycle of a gemcitabine-based therapy to be
eligible. Patients who have received gemcitabine in the adjuvant setting but
progressed within 6 months of their last cycle will be eligible for the study.
2. Presence of measurable disease as assessed by CT scan of the chest, abdomen and pelvis
based on RECIST 1.1.
3. ECOG performance status of 0 or 1.
4. Expected life expectancy of ≥ 3 months.
5. Age 18 years and above
6. Able to swallow and retain oral medication.
7. Adequate hematologic function defined by the following laboratory parameter:
1. Hemoglobin ≥ 9g/dL
2. Absolute neutrophil count ≥1.5 x 109/L
3. Platelet count ≥75x 109/L
8. Adequate hepatic and renal function as defined by:
1. AST and ALT ≤ 3.0 X ULN (≤ 5 if liver metastasis present)
2. Total bilirubin ≤ 1.5X ULN
3. Calculated creatinine clearance ≥50 ml/min using Cockcroft-Gault formula
9. Patients who have treated brain metastasis (via local radiation standards or surgical
resection or local techniques) and who are either off steroids or on a stable dose of
steroids for at least one month (30 days), AND who are off anticonvulsants, AND have
radiological documented stability of lesions for at least 3 months may be eligible.
10. Patients must have the ability to read, understand, and sign an informed consent and
must be willing to comply with study treatment and procedures.
Exclusion Criteria:
1. Any malignancy related to HIV, history of HIV, history of known HBV surface antigen
positivity (subjects with documented laboratory evidence of HBV clearance may be
enrolled) or positive HCV antibody. Testing for these diseases is not mandatory unless
clinically indicated
2. Chemotherapy, radiotherapy, immunotherapy, or other anti-cancer therapy including
investigational drugs within 28 days prior to enrolment.
3. Patients with unresolved Grade 3/4 toxicities from prior therapies.
4. Any major surgery within the last four weeks.
5. Previous or concurrent malignancies, excluding curatively treated in situ carcinoma of
the cervix or uterus or non-melanoma skin cancer or in-situ carcinoma of the prostate
(Gleason score ≤ 7, with all treatment being completed 6 months prior to enrollment,
unless at least 5 years have elapsed since last treatment and the patient is
considered cured)
6. Patients with locally or centrally known FGFR2 fusion (Sunnybrook, Ottawa and PMCC
sites only).
7. Female patients of childbearing potential and men able to father children who do not
agree to use adequate methods of contraception from time of enrolment until 6 months
after the last date of treatment administration.
8. Women who are breastfeeding
9. Patients with suspected or documented leptomeningeal disease.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT04076761
Organization ID
CTO 1645
Responsible Party
Sponsor
Study Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Taiho Oncology, Inc.
Study Sponsor
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Verification Date
November 2022