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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Genta Incorporated.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Genta Incorporated
ClinicalTrials.gov Identifier:
NCT01095120
First received: March 26, 2010
Last updated: March 14, 2012
Last verified: March 2012
  Purpose

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: Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 12 months from date of first dose of study medication ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Through 30 days post last dose of study medication ] [ Designated as safety issue: Yes ]

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01095120

Locations
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
Investigators
Study Chair: Jaffer Ajani, MD The University of Texas MD Anderson Cancer Center
  More Information

No publications provided

Responsible Party: Genta Incorporated
ClinicalTrials.gov Identifier: NCT01095120     History of Changes
Other Study ID Numbers: TOG201
Study First Received: March 26, 2010
Last Updated: March 14, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Stomach Diseases

ClinicalTrials.gov processed this record on November 20, 2014