Study of TRIFLURIDINE/TIPIRACIL in Previously Treated Cholangiocarcinoma

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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

47

Start Date

December 11, 2019

Completion Date

September 2022

Primary Completion Date

September 2021

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

, 416-480-4662, [email protected]

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 Pharma Canada, Inc.

Study Sponsor

, , 


Verification Date

March 2020