Phase II Study of Tesetaxel in Metastatic Melanoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genta Incorporated
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01064713
First received: February 5, 2010
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Advanced Melanoma
Cancer
Drug: Tesetaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Tesetaxel as Second-line Therapy for Subjects With Advanced Melanoma and Normal Serum LDH

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Response rate (ie, the percentage of subjects with a confirmed complete or partial response) [ Time Frame: Baseline to Day 84 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 54
Study Start Date: February 2010
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tesetaxel
Therapy initiated at a flat dose of 40 mg for subjects in Cohort A and at a flat dose of 50 mg for subjects in Cohort B. Tesetaxel administered orally once every 21 days until the subject meets a withdrawal criterion or initiates nonstudy therapy for melanoma. Duration of protocol therapy will not exceed 12 months.
Drug: Tesetaxel

Cohort A: 40 mg by mouth every 21 days.

Cohort B. 50 mg by mouth every 21 days.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 [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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064713

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Genta Incorporated
Investigators
Study Chair: Agop Y. Bedikian, MD, BS UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01064713     History of Changes
Other Study ID Numbers: 2009-0624
Study First Received: February 5, 2010
Last Updated: April 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Tesetaxel
Second-line therapy
Metastatic melanoma
Normal serum LDH

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on April 16, 2014