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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Genta Incorporated.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Genta Incorporated Identifier:
First received: March 26, 2010
Last updated: March 14, 2012
Last verified: March 2012
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.

Condition Intervention Phase
Adenocarcinoma of the Stomach
Adenocarcinoma of Esophagogastric Junction
Drug: Tesetaxel
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Genta Incorporated:

Primary Outcome Measures:
  • Response rate (Response Evaluation Criteria In Solid Tumors (RECIST)) [ Time Frame: 12 months from date of first dose of study medication ]

Secondary Outcome Measures:
  • 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) [ Time Frame: 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) [ Time Frame: 12 months from date of first dose of study medication ]
  • Duration of response [ Time Frame: 12 months from date of first dose of study medication ]
  • Adverse events [ Time Frame: Through 30 days post last dose of study medication ]

Estimated Enrollment: 27
Study Start Date: March 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Tesetaxel

    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.

    Other Name: DJ-927

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01095120

United States, Illinois
Northwestern Medical Faculty Foundation
Chicago, Illinois, United States, 60611
United States, Pennsylvania
Abramson Cancer of the University of Pennsylvania at Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
The University of Texax MD Anderson Cancer Center
Houston, Texas, United States, 77030
Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Genta Incorporated
Study Chair: Jaffer Ajani, MD The University of Texas MD Anderson Cancer Center
  More Information

Responsible Party: Genta Incorporated Identifier: NCT01095120     History of Changes
Other Study ID Numbers: TOG201
Study First Received: March 26, 2010
Last Updated: March 14, 2012

Additional relevant MeSH terms:
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases processed this record on April 26, 2017