Tesetaxel as Second-line Therapy for Patients With Advanced Melanoma and Normal Serum LDH
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Outcome Measures
Primary Outcome Measures
- Response rate (RECIST) [12 months from date of first dose of study medication]
Secondary Outcome Measures
- Proportion of patients with a confirmed complete or partial response at least 3 months in duration [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) [12 months from date of first dose of study medication]
- Durable response rate (ie, the proportion of patients with a confirmed complete or partial response at least 6 months in duration) [12 months from date of first dose of study medication]
- Duration of response [12 months from date of first dose of study medication]
- Adverse events [Through 30 days post last dose of study medication]
Eligibility Criteria
Criteria
Primary inclusion criteria:
-
Histologically confirmed diagnosis of melanoma
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Progressive disease that is not surgically resectable, or metastatic Stage IV disease
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Measurable disease (revised RECIST; Version 1.1)
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Serum LDH not more than 1.1 times the upper limit of normal
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Eastern Cooperative Oncology Group performance status 0 or 1
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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.)
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Adequate bone marrow, hepatic, and renal function, as specified in the protocol
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At least 3 weeks and recovery from effects of prior surgery or other therapy with an approved or investigational agent
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Ability to swallow an oral solid-dosage form of medication
Primary exclusion criteria:
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History or presence of brain metastasis or leptomeningeal disease
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Primary ocular or mucosal melanoma
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Significant medical disease other than cancer
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Organ allograft
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Presence of neuropathy > Grade 1 (National Cancer Institute Common Toxicity Criteria [NCI CTC]; Version 4.0)
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Prior treatment with a taxane or other tubulin-targeted agent (eg, indibulin) other than a vinca alkaloid
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Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Genta Incorporated
Investigators
- Principal Investigator: Agop Y Bedikian, MD, The University of Texas MD Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TOM202