Phase II Study of Tesetaxel in Metastatic Melanoma
Condition: Advanced Melanoma; Cancer
MeSH terms: Melanoma
Intervention: Tesetaxel
Intervention description: Cohort A: 40 mg by mouth every 21 days.
Cohort B. 50 mg by mouth every 21 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tesetaxel; Second-line therapy; Metastatic melanoma; Normal serum LDH

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.
    

Eligibility 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 </= 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 [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. 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.