Status:
UNKNOWN
Tesetaxel for Previously Treated Patients With Bladder Cancer
Lead Sponsor:
Genta Incorporated
Conditions:
Carcinoma, Transitional Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The intravenously administered taxanes, docetaxel and paclitaxel, alone and in combination with other chemotherapy agents are active in patients with advanced and metastatic bladder cancer, and agents...
Eligibility Criteria
Inclusion
- At least 18 years of age
- Histologically confirmed diagnosis of urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis
- Measurable disease (revised RECIST; Version 1.1)
- Karnofsky performance status ≥ 60%
- Previously treated with not more than 1 doublet or triplet regimen and that regimen contained gemcitabine and a platinum agent
- Adequate bone marrow, hepatic, and renal function, as specified in the protocol
- At least 4 weeks and recovery from effects of prior surgery, prior radiotherapy, or other therapy with an approved or investigational agent
- Ability to swallow an oral solid-dosage form of medication
Exclusion
- Known metastasis or symptoms of metastasis to the central nervous system
- Significant medical disease other than cancer
- Presence of neuropathy \> Grade 1 (NCI CTC, Version 4.0)
- Prior treatment with a taxane or other tubulin-targeted agent (eg, indibulin) other than a vinca alkaloid
- Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01215877
Start Date
September 1 2010
End Date
December 1 2012
Last Update
July 11 2012
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
2
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
3
San Camillo Forlanini Hospital
Rome, Italy, 00152