| Study Name |
|
Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver |
| ClinicalTrials.gov Identifier (if applicable) |
|
NCT04175912 |
| Clinical Trial Category (check all that apply) |
|
- Beyond First Line Therapy
- Chemotherapy
- Targeted Therapy
|
| Study Center |
| Institution Name |
|
ECOG-ACRIN Cancer Research Group |
| State |
|
– Please Select – |
| Country |
|
United States |
| Website |
|
https://clinicaltrials.gov/ct2/show/NCT04175912?term=ea2187&draw=2&rank=1#contacts |
| Study Contacts |
| Principal Investigator |
|
Dustin A. Deming, MD |
| P.I. Phone |
|
(608) 265-1042 |
| P.I. Email |
|
ddeming@medicine.wisc.edu |
| List additional Principal Investigators (include phone number and email) |
|
Anita Turk, MD
(317) 274-0335
aaturk@iu.edu |
| Study Coordinator |
|
Sarah Milardo |
| Study Coordinator Phone |
|
(857) 504-2995 |
| Study Coordinator Email |
|
smilardo@ecog-acrin.org |
| OVERVIEW – in layman’s terms (150 words max) |
|
This phase II trial studies how well the drug pevonedistat—when given alone or in combination with chemotherapy (paclitaxel and carboplatin)—works in treating patients with bile duct cancer of the liver. Pevonedistat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. |
| Enrollment |
|
52 patients |
| Study Start Date |
|
01/31/2020 |
| Estimated Completion Date |
|
11/01/2022 |
| Purpose of the Study – in Layman’s Terms (use the “+” to add more list items) |
|
- To find out whether the drug pevonedistat can stop your bile duct cancer from getting worse when taken alone and in combination with chemotherapy
- To evaluate the safety profile of pevonedistat alone and in combination with carboplatin and paclitaxel in patients with bile duct cancer
|
| Inclusion Criteria – Patients Must: |
|
- Have histologically confirmed intrahepatic cholangiocarcinoma or biphasic hepatocellular carcinoma and cholangiocarcinoma that is metastatic or unresectable and who have progressed on or been intolerant of one prior line of systemic gemcitabine-containing chemotherapy regimen. Prior immunotherapy/targeted therapies are allowed and will not be considered a line of therapy unless administered with cytotoxic chemotherapy.
- Have measurable disease
- Have an Eastern Cooperative Oncology Group (ECOG performance status of 0 or 1
- Be 18 years or older
|
| Exclusion Criteria – Patients Must NOT: |
|
- Have had major surgery within 14 days before randomization. Patients with surgery planned during study period are ineligible
- Have received chemotherapy or radiotherapy within 2 weeks prior to randomization.
- Have received immunotherapy within 8 weeks prior to randomization
- Have persistent >= grade 2 diarrhea lasting more than 3 days within 14 weeks of randomization
- Be receiving any other investigational agents
- Have chronic obstructive pulmonary disease, interstitial lung disease, and pulmonary fibrosis
- Have known central nervous system (CNS) involvement
- Be pregnant or breastfeeding
|
| POTENTIAL SIDE-EFFECTS – in layman’s terms |
|
- Pevonedistat: Diarrhea, nausea, vomiting, tiredness, fever, loss of appetite, pain
- Carboplatin: Infection, especially when white blood cell count is low; bruising, bleeding; anemia which may cause tiredness, or may require blood transfusions; vomiting, nausea, pain, hair loss
- Paclitaxel: Allergic reaction which may cause rash, low blood pressure, wheezing, shortness of breath, swelling of the face or throat; infection, especially when white blood cell count is low; bruising, bleeding; anemia which may cause tiredness, or may require blood transfusions; pain; mouth sores; diarrhea, nausea, vomiting; muscle weakness; numbness, tingling or pain of the arms and legs; hair loss
|
