Tesetaxel as Second-line Therapy for Patients With Advanced Gastric Cancer

NCT01095120 | Unknown Phase 2

• 1 other identifier: TOG201
• Study Type: interventional
• Target: 27
• Locations: 2 countries
• Sites: 4

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 gastric cancer.

Conditions

Adenocarcinoma of the Stomach; Adenocarcinoma of Esophagogastric Junction

Outcome Measures

Primary Outcomes (1)

• Response rate (Response Evaluation Criteria In Solid Tumors (RECIST))

  12 months from date of first dose of study medication

Secondary Outcomes (4)

• Disease control rate (ie, the percentage of patients with a confirmed complete or partial response [of any duration] or stable disease at least 6 weeks in duration)

  12 months from date of first dose of study medication

• Durable response rate (ie, the proportion of patients with a confirmed complete or partial response at least 6 months in duration)

  12 months from date of first dose of study medication

• Duration of response

  12 months from date of first dose of study medication

• Adverse events

  Through 30 days post last dose of study medication

Interventions

Tesetaxel DRUG

For subjects in Cohort A, a flat dose of 40 mg will be administered in Cycle 1; the dose will be adjusted based on body weight. In subsequent cycles, depending on tolerability, the Cycle 1 flat dose may be increased by 5 mg in Cycle 2, and the Cycle 2 flat dose may again be increased by 5 mg in Cycle 3. For subjects in Cohort B, a flat dose of 50 mg will be administered in Cycle 1; the dose will be adjusted based on body weight. In subsequent cycles, depending on tolerability, the dose may be increased by 10 mg in Cycle 2. For subjects in Cohort C, a dose of 27 mg/m2 will be administered in Cycle 1. In subsequent cycles, depending on tolerability, the dose will be increased to 35 mg/m2 in Cycle 2.

Also known as: DJ-927

Eligibility Criteria

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

You may qualify if:

• Confirmed diagnosis of adenocarcinoma of the stomach or esophagogastric junction
• Measurable disease (revised RECIST; Version 1.1) based on computed tomography
• Eastern Cooperative Oncology Group performance status 0 or 1
• Treatment with only 1 prior regimen (as first-line therapy) and that regimen included a fluoropyrimidine and/or a platinum analogue
• Documented disease progression within 4 months of the last dose of the 1 prior regimen
• Adequate bone marrow, hepatic, and renal function, as defined in the protocol
• At least 4 weeks and recovery from effects of prior surgery or other therapy, including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy, with an approved or investigational agent
• Ability to swallow an oral solid-dosage form of medication

You may not qualify if:

• Nonmeasurable disease only (revised RECIST; Version 1.1)
• History or presence of brain metastasis or leptomeningeal disease
• Operable gastric cancer or operable cancer of the esophagogastric junction
• Uncontrolled diarrhea, defined as more than 3 loose bowel movements above the patient's usual number of bowel movements on at least 2 days within the 14 days prior to enrollment
• Uncontrolled nausea or vomiting within the 14 days prior to enrollment despite the administration of standard antiemetic therapy
• Known malabsorptive disorder
• Significant medical disease other than cancer, as defined in the protocol
• 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

Sponsors & Collaborators

• Genta Incorporated: lead

Study Sites (4)

Northwestern Medical Faculty Foundation

Chicago, Illinois, 60611, United States

Location

Abramson Cancer of the University of Pennsylvania at Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

The University of Texax MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Severance Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

tesetaxel

Study Officials

• Jaffer Ajani, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: March 26, 2010
• First Posted: March 29, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 15, 2012

Record last verified: 2012-03

Locations

US (3); KR (1)