CholangiocarcinomaPhase 2MOCHANCT04076761
Study of TRIFLURIDINE/TIPIRACIL in Previously Treated Cholangiocarcinoma
A Phase 2 study testing Trifluridine/Tipiracil in people with Cholangiocarcinoma and Bile Duct Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma, Bile Duct Cancer
- What is being tested?
- Trifluridine/Tipiracil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 11 Dec 2019to 30 Sep 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Presence of measurable disease as assessed by CT scan of the chest, abdomen and pelvis based on RECIST 1.1.
- ECOG performance status of 0 or 1.
- Expected life expectancy of ≥ 3 months.
- Age 18 years and above
- Able to swallow and retain oral medication.
Show all 16Show fewer
- Adequate hematologic function defined by the following laboratory parameter:
- Hemoglobin ≥ 9g/dL
- Absolute neutrophil count ≥1.5 x 109/L
- Platelet count ≥75x 109/L
- Adequate hepatic and renal function as defined by:
- AST and ALT ≤ 3.0 X ULN (≤ 5 if liver metastasis present)
- Total bilirubin ≤ 1.5X ULN
- Calculated creatinine clearance ≥50 ml/min using Cockcroft-Gault formula
- 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.
- Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and procedures.
Who cannot join
- 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
- Chemotherapy, radiotherapy, immunotherapy, or other anti-cancer therapy including investigational drugs within 28 days prior to enrolment.
- Patients with unresolved Grade 3/4 toxicities from prior therapies.
- Any major surgery within the last four weeks.
- 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)
- Patients with locally or centrally known FGFR2 fusion (Sunnybrook, Ottawa and PMCC sites only).
Show all 9Show fewer
- 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.
- Women who are breastfeeding
- Patients with suspected or documented leptomeningeal disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Centre, Open-Label Phase 2 Study of TRIFLURIDINE/TIPIRACIL in Previously Treated Cholangiocarcinoma (The MOCHA Trial)
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.
- Conditions
- Cholangiocarcinoma, Bile Duct Cancer
- Being tested
- Trifluridine/Tipiracil
- Keywords
- Cholangiocarcinoma, Bile Duct Cancer, FTD/TPI, TRIFLURIDINE/TIPIRACIL
- Medical subject headings
- Cholangiocarcinoma, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trifluridine/TipiracilDrug
Also called FTD/TPI, Lonsurf
FTD/TPI is an orally administered combination of a thymidine-based nucleic acid analogue, trifluridine, and a thymidine phosphorylase inhibitor, tipiracil hydrochloride. Trifluridine is the active cytotoxic component of FTD/TPI; its triphosphate form is incorporated into DNA, with such incorporation appearing to result in its anti- tumor effects. Tipiracil hydrochloride is a potent inhibitor of thymidine phosphorylase and, when combined with trifluridine to form FTD/TPI, prevents the rapid degradation of the trifluridine, allowing for the maintenance of adequate plasma levels of the active drug.
| Study group | Role | What they receive |
|---|---|---|
| Trifluridine/Tipiracil | Experimental | 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. Receives: Drug: Trifluridine/Tipiracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median progression-free survival (PFS)
As measured on the basis of RECIST v1.1 criteria
Measured: From enrolment until the date of objective radiological disease progression according to RECIST v1.1 or death (by any cause in the absence of progression) up to 1 year
Secondary outcomes (5)
Safety and tolerability of FTD/TPI: CTCAE version 5.0
Assessed by using CTCAE version 5.0 and tolerability
Measured: Day 1 of each new treatment cycle (each cycle is 28 days), and at the end of treatment visit (up to 1 year after enrolment)
Disease Control Rate (Complete Response, Partial Response, Stable Disease) of FTD/TPI
As measured on the basis of RECIST v1.1 criteria
Measured: From enrolment until the date of objective radiological disease progression according to RECIST v1.1 or death (by any cause in the absence of progression) up to 1 year
Duration of response of FTD/TPI
As measured on the basis of RECIST v1.1 criteria
Measured: From enrolment until the date of objective radiological disease progression according to RECIST v1.1 or death (by any cause in the absence of progression) up to 1 year
Median overall survival of patients with cholangiocarcinoma treated with FTD/TPI.
As measured on the basis of RECIST v1.1 criteria
Measured: From enrolment until the date of objective radiological disease progression according to RECIST v1.1 or death (by any cause in the absence of progression) up to 1 year
Quality of life: European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30
As measured by the European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ C30) Functioning, symptoms, and global health status scores will be calculated, graphed, and summarized at baseline and each follow-up visit. General linear mixed model will be conducted to detect significant changing over time for functioning, symptoms and global health status scores. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems
Measured: Baseline, and Day 1 of each new treatment cycle (each cycle is 28 days), and at the end of treatment visit (up to 1 year after enrolment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start11 Dec 2019
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Why it stopped: Lack of Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Taiho Oncology, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076761
- Sponsor's protocol ID
- CTO 1645
- Acronym
- MOCHA
- Status last verified
- Nov 2022
- First submitted
- 22 Aug 2019
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Open-Label Phase 2 Study of TRIFLURIDINE/TIPIRACIL in Previously Treated Cholangiocarcinoma (The MOCHA Trial)
- ClinicalTrials.gov ID
- NCT04076761
- Acronym / sponsor ID
- MOCHA / CTO 1645
- Conditions
- Cholangiocarcinoma, Bile Duct Cancer
- Keywords
- Cholangiocarcinoma, Bile Duct Cancer, FTD/TPI, TRIFLURIDINE/TIPIRACIL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Funding
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Taiho Oncology, Inc.
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 3 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trifluridine/Tipiracil | Experimental | Drug: Trifluridine/TipiracilFTD/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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
- Presence of measurable disease as assessed by CT scan of the chest, abdomen and pelvis based on RECIST 1.1.
- ECOG performance status of 0 or 1.
- Expected life expectancy of ≥ 3 months.
- Age 18 years and above
Key exclusion criteria (9 listed)
- 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
- Chemotherapy, radiotherapy, immunotherapy, or other anti-cancer therapy including investigational drugs within 28 days prior to enrolment.
- Patients with unresolved Grade 3/4 toxicities from prior therapies.
- Any major surgery within the last four weeks.
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trifluridine/TipiracilAlso: FTD/TPI, LonsurfFTD/TPI is an orally administered combination of a thymidine-based nucleic acid analogue, trifluridine, and a thymidine phosphorylase inhibitor, tipiracil hydrochloride. Trifluridine is the active cytotoxic component of FTD/TPI; its triphosphate form is incorporated into DNA, with such incorporation appearing to result in its anti- tumor effects. Tipiracil hydrochloride is a potent inhibitor of thymidine phosphorylase and, when combined with trifluridine to form FTD/TPI, prevents the rapid degradation of the trifluridine, allowing for the maintenance of adequate plasma levels of the active drug. | Drug | Trifluridine/Tipiracil |
Primary outcome
Median progression-free survival (PFS)
Time frame: From enrolment until the date of objective radiological disease progression according to RECIST v1.1 or death (by any cause in the absence of progression) up to 1 year
As measured on the basis of RECIST v1.1 criteria
5 secondary outcomes
Safety and tolerability of FTD/TPI: CTCAE version 5.0
Time frame: Day 1 of each new treatment cycle (each cycle is 28 days), and at the end of treatment visit (up to 1 year after enrolment)
Disease Control Rate (Complete Response, Partial Response, Stable Disease) of FTD/TPI
Time frame: From enrolment until the date of objective radiological disease progression according to RECIST v1.1 or death (by any cause in the absence of progression) up to 1 year
Duration of response of FTD/TPI
Time frame: From enrolment until the date of objective radiological disease progression according to RECIST v1.1 or death (by any cause in the absence of progression) up to 1 year
Median overall survival of patients with cholangiocarcinoma treated with FTD/TPI.
Time frame: From enrolment until the date of objective radiological disease progression according to RECIST v1.1 or death (by any cause in the absence of progression) up to 1 year
Quality of life: European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30
Time frame: Baseline, and Day 1 of each new treatment cycle (each cycle is 28 days), and at the end of treatment visit (up to 1 year after enrolment)
Results and safety
The study was stopped early (reason given: Lack of Funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
Related trials for Cholangiocarcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingObservational study
Liver Cancer Registry Platform
Hepatocellular Carcinoma (HCC), Cholangiocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trifluridine/Tipiracil in people with Cholangiocarcinoma and Bile Duct Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of Funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median progression-free survival (PFS) (time frame: From enrolment until the date of objective radiological disease progression according to RECIST v1.1 or death (by any cause in the absence of progression) up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.