Study of Tesetaxel in Japanese Patients With Solid Tumors

Genta Incorporated

Status and phase: Unknown; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: Tesetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01337310

TOPK106

Details and patient eligibility

About

Tesetaxel is an orally active tubulin-binding inhibitor of the taxane class. Evaluation of tesetaxel in Japanese patients has been limited. This study is being conducted to determine the maximum tolerated dose and safety of tesetaxel administered orally once every 21 days to Japanese patients.

Enrollment: 12 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Primary inclusion criteria:

• At least 20 years of age
• Morphologic or cytologic confirmation of an advanced or metastatic solid tumor malignancy, not to include lymphoma, for which no standard therapy exists or for which resistance or intolerance to standard therapy has developed
• ECOG performance status not more than 1
• Adequate bone marrow, hepatic, and renal function
• Willing to remain hospitalized for at least 10 days following tesetaxel administration in Cycle 1
• At least 4 weeks and recovery from effects of prior surgery or other therapy with an approved or investigational agent, with resolution of any toxicity to not more than Grade 1

Primary exclusion criteria:

• Brain metastasis or leptomeningeal disease
• Significant medical disease other than cancer
• Neuropathy greater than Grade 1

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Tesetaxel

Experimental group

Description:

Tesetaxel administered orally once every 21 days for at least 2 cycles

Treatment:

Drug: Tesetaxel