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Report for Clinical Trial NCT02535650

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

An Open Label Phase II Study of Tipifarnib in Patients With Previously-Treated, Advanced, HRAS Mutant Urothelial Carcinoma

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.

NCT02535650 Urothelial Carcinoma
MeSH:Carcinoma Carcinoma, Transitional Cell

1 Interventions

Name: tipifarnib

Description: 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.
Type: Drug
Group Labels: 1


Primary Outcomes

Measure: 6-month progression-free survival

Time: Up to 6 months for each subject

Secondary Outcomes

Measure: Duration of response

Time: Up to 12 months for each subject

Measure: Overall survival

Time: Until the date of death from any cause, whichever came first, assessed up to 1 year 6 months.

Description: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0(Common Toxicity Criteria for Adverse Effects )

Measure: Safety and Tolerability

Time: Up to 12 months for each subject

Purpose: Treatment

Allocation: N/A

Single Group Assignment

There is one SNP


1 rs2075606

(missence non-synonymous HRAS mutation and/or STK11: rs2075606 (T>C))HRAS status may have been assessed either in primary tumor tissue, recurrent or metastatic disease. 5. Subject has consented to provide at least 10 unstained tumor slides for retrospective testing of HRAS gene tumor status.

HPO Nodes