Tesetaxel for Previously Treated Patients With Bladder Cancer
Status unconfirmed · Phase 2
Conditions studied: Carcinoma, Transitional Cell
In brief
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 of this class are a promising treatment option for some patients. Tesetaxel is an orally administered taxane that is in development as treatment for subjects with advanced cancers. This study is being conducted to determine the efficacy and safety of tesetaxel administered to patients previously treated with chemotherapy for progressive metastatic transitional cell carcinoma of the urothelium.
Key facts
- Study ID
- NCT01215877
- Run by
- Genta Incorporated
- People needed
- 33
- Starts
- 2010-09-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2012-07-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States (enrolling)
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (enrolling)
- San Camillo Forlanini Hospital — Rome, Italy (enrolling)
Full record on ClinicalTrials.gov
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