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

Primary Purpose

Adenocarcinoma of the Stomach, Adenocarcinoma of Esophagogastric Junction

Status

Unknown status

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Tesetaxel

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Stomach

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Northwestern Medical Faculty Foundation
Abramson Cancer of the University of Pennsylvania at Perelman Center for Advanced Medicine
The University of Texax MD Anderson Cancer Center
Severance Hospital, Yonsei University Health System

Outcomes

Primary Outcome Measures

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

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)

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

Duration of response

Adverse events

Full Information

NCT ID

NCT01095120

First Posted

March 26, 2010

Last Updated

March 14, 2012

Sponsor

Genta Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT01095120

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Unknown status

Study Start Date

March 2010 (undefined)

Primary Completion Date

September 2012 (Anticipated)

Study Completion Date

October 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genta Incorporated

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenocarcinoma of the Stomach, Adenocarcinoma of Esophagogastric Junction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

27 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Tesetaxel

Other Intervention Name(s)

DJ-927

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

12 months from date of first dose of study medication

Secondary Outcome Measure Information:

Title

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

Title

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

Title

Duration of response

Time Frame

12 months from date of first dose of study medication

Title

Adverse events

Time Frame

Through 30 days post last dose of study medication

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jaffer Ajani, MD

Organizational Affiliation

The University of Texas MD Anderson Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

Northwestern Medical Faculty Foundation

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

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

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

The University of Texax MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Severance Hospital, Yonsei University Health System

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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