| ClinicalTrials.gov Identifier |
| NCT04203160 |
| Institution Name |
| University of Michigan Rogel Cancer Center |
| Institution Address (Street) |
| 1500 E Medical Center Dr. |
| Institution City |
| Ann Arbor |
| Institution State |
| Michigan |
| Institution ZIP Code |
| 48109 |
| Institution Country |
| United States |
| Institution Phone |
| (800) 865-1125 |
| Institution Website |
| https://clinicaltrials.gov/ct2/show/NCT04203160 |
| Additional Institutions |
- University of Texas Southwestern
- University of Washington
|
| Principal Investigator |
| Vaibhav Sahai, MBBS, MS |
| Principal Investigator Phone |
| (800) 865-1125 |
| Principal Investigator Email |
| CancerAnswerLine@med.umich.edu |
| Additional Principal Investigators |
- Muhammad Shalaan Beg, MD at UT Southwestern
- David Zhen, MD at University of Washington
|
| Study Coordinator |
| Meghan Johnson |
| Study Coordinator Phone |
| (800) 865-1125 |
| Study Coordinator Email |
| CancerAnswerLine@med.umich.edu |
| Study Overview |
| Patients with advanced biliary cancer (gallbladder or cholangiocarcinoma) previously untreated with systemic chemotherapy will receive gemcitabine + cisplatin + CPI-613 (targets enzymes that are involved in cancer cell energy metabolism). |
| Enrollment Information |
| 78 |
| Study Start Date |
| 20200601 |
| Study End Date |
| 20250630 |
| Study Purpose |
- Improve survival of patients with advanced biliary cancer
- Identify safe dose of CPI-613 (devimistat) when given in combination with gemcitabine and cisplatin
|
| Inclusion Criteria |
- Tissue diagnosis of advanced, surgically inoperable biliary cancer
- No prior systemic chemotherapy for advanced cancer
- May have previously undergone radiation, liver directed therapy or surgery
- Must have measurable disease on CT or MR scans
- Age >= 18 years
- Performance status ECOG 0 or 1
- Must be able to tolerate CT or MRI scans
- Adequate organ function (per protocol)
|
| Exclusion Criteria |
- No brain metastasis unless treated and stable for 3 months
- Underwent a major surgical procedure < 4 weeks prior to enrollment
- No prior organ transplantation
- No ongoing or uncontrolled infection
- Must not be pregnant or breast feeding
- No other active cancer (with some exceptions such as localized skin cancer)
- No active heart disease including symptomatic heart failure (NYHA class 3 or 4), unstable angina pectoris, uncontrolled cardiac arrhythmia or interstitial lung disease
- No prisoners or subjects who are involuntarily incarcerated, or compulsorily detained
- Prolonged QTcF interval >480 msec on ECG
- Psychiatric illness, other significant medical illness, or social situation which may limit compliance
|
| Required Tests Prior to Study |
- Blood tests, CT or MR scans
|
| Potential Side Effects |
- Tiredness (fatigue)
- Low blood counts (e.g. anemia)
- Nausea (usually mild to moderate) from cisplatin and/or gemcitabine
- Potential for kidney damage from cisplatin and/or gemcitabine
- Potential for hearing loss / ringing in ears from cisplatin
- Low appetite from gemcitabine and/or cisplatin
|
| Financial Assistance Available |
| No |
