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

A Phase II Study of Tesetaxel Administered at a Flat Dose Once Every 21 Days as Second-line Therapy to Subjects With Advanced Gastric Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Adenocarcinoma of the Stomach; Adenocarcinoma of Esophagogastric Junction
• Intervention / Treatment: Drug: Tesetaxel

• Study Type: Interventional
• Enrollment (Anticipated): 27
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital, Yonsei University Health System
• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medical Faculty Foundation
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Abramson Cancer of the University of Pennsylvania at Perelman Center for Advanced Medicine
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texax MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Primary inclusion criteria:

• 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

Primary exclusion criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response rate (Response Evaluation Criteria In Solid Tumors (RECIST))	12 months from date of first dose of study medication

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Genta Incorporated
• Investigators: Study Chair: Jaffer Ajani, MD, The University of Texas MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Anticipated): September 1, 2012
• Study Completion (Anticipated): October 1, 2012

Study Registration Dates

• First Submitted: March 26, 2010
• First Submitted That Met QC Criteria: March 26, 2010
• First Posted (Estimate): March 29, 2010

Study Record Updates

• Last Update Posted (Estimate): March 15, 2012
• Last Update Submitted That Met QC Criteria: March 14, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: TOG201