Phase II Study of Tesetaxel in Metastatic Melanoma

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 </= 1.1 times the upper limit of normal (x ULN).
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) </= 2.5 x ULN or, in the presence of liver metastasis, </= 5 x ULN; e) Alanine aminotransferase (ALT) </= 2.5 x ULN or, in the presence of liver metastasis, </= 5 x ULN f. Total bilirubin </= 1.5 x ULN;
9. (Continued # 8) g) Alkaline phosphatase </= 2.5 x ULN or, in the presence of liver metastasis, </= 5 x ULN or, in the presence of bone metastasis, </= 10 x ULN; h) Serum creatinine </= 1.5 x ULN; i) Serum albumin >/= 3.0 g/dL; j) Prothrombin time (PT) </= 1.5 x ULN (or international normalized ratio [INR] </=1.3); k) Partial thromboplastin time (PTT) </= 1.5 x ULN.
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. 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 </= 1.1 times the upper limit of normal (x ULN).
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) </= 2.5 x ULN or, in the presence of liver metastasis, </= 5 x ULN; e) Alanine aminotransferase (ALT) </= 2.5 x ULN or, in the presence of liver metastasis, </= 5 x ULN f. Total bilirubin </= 1.5 x ULN;
9. (Continued # 8) g) Alkaline phosphatase </= 2.5 x ULN or, in the presence of liver metastasis, </= 5 x ULN or, in the presence of bone metastasis, </= 10 x ULN; h) Serum creatinine </= 1.5 x ULN; i) Serum albumin >/= 3.0 g/dL; j) Prothrombin time (PT) </= 1.5 x ULN (or international normalized ratio [INR] </=1.3); k) Partial thromboplastin time (PTT) </= 1.5 x ULN.
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.