Tesetaxel for Previously Treated Patients With Bladder Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | September 2010 |
| End Date: | December 2012 |
A Phase II Study of Tesetaxel in Subjects Previously Treated With Chemotherapy for Metastatic Transitional Cell Carcinoma of the Urothelium
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.
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.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
2
sites
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
Click here to add this to my saved trials
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
Click here to add this to my saved trials