Carcinoma, Transitional Cell
Conditions
Keywords
Bladder cancer, Previously treated patients, Tesetaxel, Oral taxane
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 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.
Interventions
DRUGTesetaxel
Tesetaxel capsules orally once every 21 days; duration of therapy not to exceed 12 months In Cycle 1, a dose of 27 mg/m2 will be administered. In subsequent cycles, * the dose will be increased to 35 mg/m2 in Cycle 2 for subjects who did not have an ANC \< 1,500/mm3, a platelet count \< 100,000/mm3, or a Grade 3 (or higher grade) nonhematologic adverse event considered by the Investigator to be related to protocol therapy (excluding alopecia, nausea, and vomiting) in Cycle 1. The dose is not to exceed the dose of 35 mg/m2 in any cycle subsequent to Cycle 2. * for all other subjects, the dose administered in Cycle 1 (27 mg/m2) will be administered in all subsequent cycles.
Sponsors
Genta Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate (revised RECIST) | 12 months from date of first dose of study medication for last patient enrolled | Proportion of patients with a confirmed complete or partial response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate | 12 months from date of first dose of study medication for last patient enrolled | Proportion of patients with a confirmed complete or partial response of any duration or stable disease ≥ 3 months in duration |
| Durable response rate | 12 months from date of first dose of study medication for last patient enrolled | Proportion of subjects with a confirmed complete or partial response ≥ 6 months in duration |
| ≥ 3-month response rate | 12 months from date of first dose of study medication for last patient enrolled | Proportion of patients with a confirmed complete or partial response ≥ 3 months in duration |
| Time to progression | 12 months from date of first dose of study medication for last patient enrolled | Date of first dose of study medication to the date when progression is first documented |
| Safety | Up to 30 days after the last dose of study medication for a specific patient | Adverse events and clinical laboratory tests |
| Duration of response | 12 months from date of first dose of study medication for last patient enrolled | Date when response criteria are first met to the date when progression is first documented |
Countries
Italy, United States
Outcome results
None listed