Recruiting
Phase 2

Tesetaxel

Sponsor:

Genta Incorporated

Code:

NCT01092585

Conditions

Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tesetaxel

Study Details

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).

Conditions

Melanoma

Study ID

NCT01092585

Start date

Feb, 2010

Status verified date

Nov, 2011

Completion date

Mar, 2012

Anticipated

Primary completion date

Mar, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

27 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Tesetaxel

Tesetaxel capsules will be administered orally once every 21 days until the patient meets a withdrawal criterion or initiates nonstudy therapy for melanoma. The duration of protocol therapy will not exceed 12 months.

In Cycle 1, a flat dose of 40 mg will be administered to patients of relatively normal weight. For patients who weigh at least 25% below their ideal body weight, a flat dose of 35 mg will be administered. For patients who weigh at least 25% above their ideal body weight, a flat dose of 45 mg will be administered. Dose escalation by 5 mg in Cycle 2 and an additional 5 mg in Cycle 3 is permitted provided protocol-specified criteria are met.

Primary outcome measure

  • Response rate (RECIST) [ Time Frame: 12 months from date of first dose of study medication ]

Central Contacts and Locations

Locations

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Karen Woodard

KLWoodard@mdanderson.org

Principal Investigator:

Agop Y Bedikian, MD

More Information

Sponsor

Genta Incorporated

Last update posted

Nov 8, 2011

Last verified

Nov, 2011

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Genta Incorporated on 2011-11-08.