Study of Tipifarnib in Patients With Previously-Treated, Advanced, HRAS Mutant Urothelial Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02535650|
Recruitment Status : Recruiting
First Posted : August 28, 2015
Last Update Posted : September 25, 2019
Platinum-based chemotherapy is now regarded a standard first-line treatment for patients with advanced urothelial carcinoma (UC). However, patients who failed to response or experienced progression after platinum-based chemotherapy have a grim prognosis and a standard salvage treatment is not available.
UC is known to harbor multiple mutations. In the investigators' own high-throughput molecular profiling study, the most commonly observed mutations included TP53, FGFR3(fibroblast growth factor receptor 3 ) and HRAS. Since RAS signaling can be attenuated using selective farnesyl transferase (FTase) inhibitors, tipifarnib, a highly potent and selective inhibitor of FTase, was proposed to be an effective therapeutic approach in the treatment of UC.
|Condition or disease||Intervention/treatment||Phase|
|Urothelial Carcinoma||Drug: tipifarnib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Phase II Study of Tipifarnib in Patients With Previously-Treated, Advanced, HRAS Mutant Urothelial Carcinoma|
|Actual Study Start Date :||November 12, 2015|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||March 2020|
Tipifarnib will be administered at a starting dose of 900 mg, po, bid on days 1-7 and 15-21 of 28-day treatment cycles.
Tipifarnib will be administered at a starting dose of 900 mg, po, bid on days 1-7 and 15-21 of 28-day treatment cycles. In the absence of unmanageable toxicities, subjects may continue to receive tipifarnib treatment for up to 12 months as long as the Investigator considers that the treatment is providing clinical benefit.
- 6-month progression-free survival [ Time Frame: Up to 6 months for each subject ]
- Duration of response [ Time Frame: Up to 12 months for each subject ]
- Overall survival [ Time Frame: Until the date of death from any cause, whichever came first, assessed up to 1 year 6 months. ]
- Safety and Tolerability [ Time Frame: Up to 12 months for each subject ]Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0(Common Toxicity Criteria for Adverse Effects )
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02535650
|Contact: Se hoon Park, MD,Ph.D.||2-3410-3459 ext email@example.com|
|Contact: yoon jeong Ahn||221487395 ext firstname.lastname@example.org|
|Korea, Republic of|
|Samsung Medical Center||Recruiting|
|Seoul, Korea, Republic of, 135710|
|Contact: Se Hoon Park, MD +82 2 3410 3459 email@example.com|