Phase II Study of Tesetaxel in Metastatic Melanoma

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to learn if tesetaxel can help to control metastatic melanoma. The safety of this drug will also be studied.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Genta Incorporated

Criteria

Inclusion Criteria:

1. At least 18 years of age.

2. Histologically confirmed diagnosis of melanoma.

3. Progressive disease that is not surgically resectable, or metastatic Stage IV disease.

4. Measurable disease.

5. Serum LDH

6. Eastern Cooperative Oncology Group performance status 0 or 1.

7. 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.)

8. Adequate bone marrow, hepatic, and renal function, as evidenced by: a) Absolute neutrophil count (ANC) >/= 1500/mm^3; b) Platelet count >/= 100,000/mm^3; c) Hemoglobin >/= 9 g/dL without need for hematopoietic growth factor or transfusion support; d) Aspartate aminotransferase (AST)liver metastasis,the presence of liver metastasis,

9. (Continued # 8) g) Alkaline phosphatasemetastasis,creatinine/= 3.0 g/dL; j) Prothrombin time (PT)1.5 x ULN (or international normalized ratio [international normalized ratio (INR)]

10. At least 3 weeks and recovery from effects of prior surgery or other therapy with an approved or investigational agent.

11. Ability to swallow an oral solid-dosage form of medication.

12. A negative serum pregnancy test within 7 days prior to the first dose of study medication in women of childbearing potential (that is, all women except for those who are post menopause for > 1 year or who have a history of hysterectomy or surgical sterilization).

13. Agreement to use a highly effective form of contraception (ie, one that has a failure rate of < 1%) throughout the treatment phase of the study in women of childbearing potential (that is, all women excluding those who are post menopause for > 1 year or who have a history of hysterectomy or surgical sterilization) and sexually active men

14. Written informed consent and authorization to use and disclose health information.

15. Ability to comprehend and to comply with the requirements of the study.

Exclusion Criteria:

1. History or presence of brain metastasis or leptomeningeal disease.

2. Primary ocular or mucosal melanoma.

3. Second cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for 5 or more years)

4. Human immunodeficiency virus infection based on history of positive serology.

5. Significant medical disease other than cancer, including but not limited to uncontrolled diabetes mellitus, active angina or heart failure, uncontrolled hypertension, or an active psychiatric condition that would prevent consistent and compliant participation in the study

6. Organ allograft.

7. Presence of neuropathy > Grade 1.

8. Prior treatment with a taxane or other tubulin-targeted agent (eg, indibulin) other than a vinca alkaloid.

9. Need for other anticancer treatment (such as chemotherapy, radiation therapy, or biologic therapy with an approved or investigational agent) while receiving protocol therapy.

10. Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity.

11. Less than 2 weeks since use of a medication or ingestion of an agent that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein.

12. Pregnancy or lactation.