Clinical trial NCT01215877: Tesetaxel for Previously Treated Patients With Bladder Cancer
Official title: A Phase II Study of Tesetaxel in Subjects Previously Treated With Chemotherapy for Metastatic Transitional Cell Carcinoma of the Urothelium
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carcinoma, Transitional Cell
Keywords: Bladder cancer
Previously treated patients
Tesetaxel
Oral taxane
Lead sponsor: Genta Incorporated
Sponsor class: INDUSTRY
First posted: 2010-10-07
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Response rate (revised RECIST)
timeFrame: 12 months from date of first dose of study medication for last patient enrolled
Secondary outcomes:
measure: ≥ 3-month response rate
timeFrame: 12 months from date of first dose of study medication for last patient enrolled
measure: Disease control rate
timeFrame: 12 months from date of first dose of study medication for last patient enrolled
measure: Durable response rate
timeFrame: 12 months from date of first dose of study medication for last patient enrolled
measure: Duration of response
timeFrame: 12 months from date of first dose of study medication for last patient enrolled
measure: Time to progression
timeFrame: 12 months from date of first dose of study medication for last patient enrolled
measure: Safety
timeFrame: Up to 30 days after the last dose of study medication for a specific patient
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Rome
country: Italy
facility: San Camillo Forlanini Hospital
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Dean F Bajorin, MD
role: PRINCIPAL_INVESTIGATOR
References: