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

Adenocarcinoma of the Stomach Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01095120
• Other study ID #: TOG201
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 26, 2010
• Last updated: March 14, 2012
• Start date: March 2010
• Est. completion date: October 2012

Study information

• Verified date: March 2012
• Source: Genta Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 27
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Esophagogastric Junction
• Adenocarcinoma of the Stomach

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
United States	Northwestern Medical Faculty Foundation	Chicago	Illinois
United States	The University of Texax MD Anderson Cancer Center	Houston	Texas
United States	Abramson Cancer of the University of Pennsylvania at Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Genta Incorporated

Countries where clinical trial is conducted

United States,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate (Response Evaluation Criteria In Solid Tumors (RECIST))		12 months from date of first dose of study medication	No
Secondary	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	No
Secondary	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	No
Secondary	Duration of response		12 months from date of first dose of study medication	No
Secondary	Adverse events		Through 30 days post last dose of study medication	Yes