Clinical trial NCT01092585: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Melanoma
Lead sponsor: Genta Incorporated
Sponsor class: INDUSTRY
First posted: 2010-03-25
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Response rate (RECIST)
timeFrame: 12 months from date of first dose of study medication
Secondary outcomes:
measure: Proportion of patients with a confirmed complete or partial response at least 3 months in duration
timeFrame: 12 months from date of first dose of study medication
measure: 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)
timeFrame: 12 months from date of first dose of study medication
measure: Durable response rate (ie, the proportion of patients with a confirmed complete or partial response at least 6 months in duration)
timeFrame: 12 months from date of first dose of study medication
measure: Duration of response
timeFrame: 12 months from date of first dose of study medication
measure: Adverse events
timeFrame: Through 30 days post last dose of study medication
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: The University of Texas MD Anderson Cancer Center
name: Agop Y Bedikian, MD
role: PRINCIPAL_INVESTIGATOR
References: