- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01092585
Tesetaxel as Second-line Therapy for Patients With Advanced Melanoma and Normal Serum LDH
November 4, 2011 updated by: Genta Incorporated
A Phase II Study of Tesetaxel as Second-line Therapy for Subjects With Advanced Melanoma and Normal Serum LDH
Tesetaxel is an orally administered chemotherapy agent of the taxane class.
This study is being undertaken to evaluate the efficacy and safety of tesetaxel administered as second-line therapy to patients with advanced melanoma and normal serum lactate dehydrogenase (LDH).
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
27
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- The University of Texas MD Anderson Cancer Center
-
Contact:
- Karen Woodard
- Email: KLWoodard@mdanderson.org
-
Principal Investigator:
- Agop Y Bedikian, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Primary inclusion criteria:
- Histologically confirmed diagnosis of melanoma
- Progressive disease that is not surgically resectable, or metastatic Stage IV disease
- Measurable disease (revised RECIST; Version 1.1)
- Serum LDH not more than 1.1 times the upper limit of normal
- Eastern Cooperative Oncology Group performance status 0 or 1
- Treatment with 1 prior regimen (including cytotoxic chemotherapy, immunotherapy, radiation therapy, or cytokine, biologic, or vaccine therapy) as first-line treatment for metastatic disease (Administration of interleukin-2 or interferon as adjuvant therapy is allowed and is not to be considered in determining the 1 prior treatment regimen administered as first-line treatment for metastatic disease.)
- Adequate bone marrow, hepatic, and renal function, as specified in the protocol
- At least 3 weeks and recovery from effects of prior surgery or other therapy with an approved or investigational agent
- Ability to swallow an oral solid-dosage form of medication
Primary exclusion criteria:
- History or presence of brain metastasis or leptomeningeal disease
- Primary ocular or mucosal melanoma
- Significant medical disease other than cancer
- Organ allograft
- Presence of neuropathy > Grade 1 (National Cancer Institute Common Toxicity Criteria [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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rate (RECIST)
Time Frame: 12 months from date of first dose of study medication
|
12 months from date of first dose of study medication
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Durable response rate (ie, the proportion of patients with a confirmed complete or partial response at least 6 months in duration)
Time Frame: 12 months from date of first dose of study medication
|
12 months from date of first dose of study medication
|
Duration of response
Time Frame: 12 months from date of first dose of study medication
|
12 months from date of first dose of study medication
|
Adverse events
Time Frame: Through 30 days post last dose of study medication
|
Through 30 days post last dose of study medication
|
Proportion of patients with a confirmed complete or partial response at least 3 months in duration
Time Frame: 12 months from date of first dose of study medication
|
12 months from date of first dose of study medication
|
Disease control rate (ie, the proportion of patients with a confirmed complete or partial response of any duration or stable disease at least 3 months in duration)
Time Frame: 12 months from date of first dose of study medication
|
12 months from date of first dose of study medication
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Agop Y Bedikian, MD, The University of Texas MD Anderson Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Anticipated)
March 1, 2012
Study Completion (Anticipated)
March 1, 2012
Study Registration Dates
First Submitted
March 23, 2010
First Submitted That Met QC Criteria
March 24, 2010
First Posted (Estimate)
March 25, 2010
Study Record Updates
Last Update Posted (Estimate)
November 8, 2011
Last Update Submitted That Met QC Criteria
November 4, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TOM202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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