Phase II Study of Tesetaxel in Metastatic Melanoma

NCT01064713 | Completed Phase 2 Results

• 2 other identifiers: 2009-0624NCI-2011-00557
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Melanoma; Cancer

Keywords

Tesetaxel; Second-line therapy; Metastatic melanoma; Normal serum LDH

Outcome Measures

Primary Outcomes (2)

• Response Rate (ie, the Percentage of Subjects With a Confirmed Complete or Partial Response)

  Determination of response performed according to the revised Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 using computed tomography (CT). Complete response: Disappearance of all target lesions; if pathologic lymph node, reduction in shortest axis to \< 10 mm; Partial response: ≥ 30% decrease in sum of diameters of target lesions relative to baseline sum diameters; Stable disease: Neither a sufficient reduction to qualify as partial response nor a sufficient increase to qualify as progression; Progressive disease ≥ 20% increase in sum diameters relative to smallest sum diameters recorded (including baseline sum diameters) in conjunction with increase of least 5 mm in that smallest sum diameters, or appearance of one or more new lesions.

  Day 84

• Number of Participants With Response

  Determination of response performed according to the revised Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 using computed tomography (CT). Complete response: Disappearance of all target lesions; if pathologic lymph node, reduction in shortest axis to \< 10 mm; Partial response: ≥ 30% decrease in sum of diameters of target lesions relative to baseline sum diameters; Stable disease: Neither a sufficient reduction to qualify as partial response nor a sufficient increase to qualify as progression; Progressive disease ≥ 20% increase in sum diameters relative to smallest sum diameters recorded (including baseline sum diameters) in conjunction with increase of least 5 mm in that smallest sum diameters, or appearance of one or more new lesions.

  Day 84

Study Arms (1)

Tesetaxel

EXPERIMENTAL

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

Interventions

Tesetaxel DRUG

Cohort A: 40 mg by mouth every 21 days. Cohort B. 50 mg by mouth every 21 days.

Tesetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age.
• Histologically confirmed diagnosis of melanoma.
• Progressive disease that is not surgically resectable, or metastatic Stage IV disease.
• Measurable disease.
• Serum LDH \</= 1.1 times the upper limit of normal (x ULN).
• 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 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;
• (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.
• 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.
• 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).
• 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
• Written informed consent and authorization to use and disclose health information.
• Ability to comprehend and to comply with the requirements of the study.

You may not qualify if:

• History or presence of brain metastasis or leptomeningeal disease.
• Primary ocular or mucosal melanoma.
• 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)
• Human immunodeficiency virus infection based on history of positive serology.
• 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
• Organ allograft.
• Presence of neuropathy \> Grade 1.
• Prior treatment with a taxane or other tubulin-targeted agent (eg, indibulin) other than a vinca alkaloid.
• Need for other anticancer treatment (such as chemotherapy, radiation therapy, or biologic therapy with an approved or investigational agent) while receiving protocol therapy.
• Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity.
• 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.
• Pregnancy or lactation.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Genta Incorporated: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Neoplasms; Melanoma

Interventions

tesetaxel

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Agop Y. Bedikian, MD/Professor
• Organization: University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Agop Y. Bedikian, MD, BS

  M.D. Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2010
• First Posted: February 8, 2010
• Study Start: February 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 17, 2018
• Results First Posted: July 17, 2018

Record last verified: 2018-07

Locations

US (1)