Back to resultsTesetaxel as Second-line Therapy for Patients With Advanced Melanoma and Normal Serum LDH
Primary Purpose
Melanoma
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tesetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma
Eligibility 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
Sites / Locations
- The University of Texas MD Anderson Cancer CenterRecruiting
Outcomes
Primary Outcome Measures
Response rate (RECIST)
Secondary Outcome Measures
Proportion of patients with a confirmed complete or partial response at least 3 months in duration
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)
Durable response rate (ie, the proportion of patients with a confirmed complete or partial response at least 6 months in duration)
Duration of response
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01092585
Brief Title
Tesetaxel as Second-line Therapy for Patients With Advanced Melanoma and Normal Serum LDH
Official Title
A Phase II Study of Tesetaxel as Second-line Therapy for Subjects With Advanced Melanoma and Normal Serum LDH
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
March 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genta Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tesetaxel
Other Intervention Name(s)
DJ-927
Intervention Description
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.
Primary Outcome Measure Information:
Title
Response rate (RECIST)
Time Frame
12 months from date of first dose of study medication
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Duration of response
Time Frame
12 months from date of first dose of study medication
Title
Adverse events
Time Frame
Through 30 days post last dose of study medication
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agop Y Bedikian, MD
Organizational Affiliation
The University of Texas MD Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Woodard
Email
KLWoodard@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Agop Y Bedikian, MD
12. IPD Sharing Statement
Learn more about this trial
Tesetaxel as Second-line Therapy for Patients With Advanced Melanoma and Normal Serum LDH
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