Tesetaxel as Second-line Therapy for Patients With Advanced Melanoma and Normal Serum LDH

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Genta Incorporated.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Genta Incorporated
ClinicalTrials.gov Identifier:
NCT01092585
First received: March 23, 2010
Last updated: November 4, 2011
Last verified: November 2011
  Purpose

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).


Condition Intervention Phase
Melanoma
Drug: Tesetaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: 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 Genta Incorporated:

Primary Outcome Measures:
  • Response rate (RECIST) [ Time Frame: 12 months from date of first dose of study medication ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with a confirmed complete or partial response at least 3 months in duration [ Time Frame: 12 months from date of first dose of study medication ] [ Designated as safety issue: No ]
  • Disease control rate (ie, the proportion of patients with a confirmed complete or partial response of any duration or stable disease at least 3 months in duration) [ Time Frame: 12 months from date of first dose of study medication ] [ Designated as safety issue: No ]
  • Durable response rate (ie, the proportion of patients with a confirmed complete or partial response at least 6 months in duration) [ Time Frame: 12 months from date of first dose of study medication ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 12 months from date of first dose of study medication ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Through 30 days post last dose of study medication ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 27
Study Start Date: February 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 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.

    Other Name: DJ-927
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092585

Locations
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Karen Woodard       KLWoodard@mdanderson.org   
Principal Investigator: Agop Y Bedikian, MD         
Sponsors and Collaborators
Genta Incorporated
Investigators
Principal Investigator: Agop Y Bedikian, MD The University of Texas MD Anderson Cancer Center
  More Information

No publications provided

Responsible Party: Genta Incorporated
ClinicalTrials.gov Identifier: NCT01092585     History of Changes
Other Study ID Numbers: TOM202
Study First Received: March 23, 2010
Last Updated: November 4, 2011
Health Authority: United States: Food and Drug Administration

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 July 24, 2014