Tesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer

March 11, 2012 updated by: Genta Incorporated

A Phase I-II Study of Tesetaxel Plus Capecitabine and Cisplatin in Subjects With Advanced Gastric Cancer

Cisplatin, an intravenously administered platinum agent, in combination with an intravenously administered taxane and capecitabine has been shown to improve time to disease progression and overall survival in previously untreated patients with gastric cancer.

This study is being performed to evaluate an orally administered taxane (tesetaxel) in combination with cisplatin and capecitabine in previously untreated patients with gastric cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

63

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Yonsei Cancer Center, Yonsei University College of Medicine
        • Contact:
          • Sun Young Rha, MD
          • Phone Number: 82-2-2228-8050

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Primary Inclusion Criteria:

  • At least 20 years of age
  • Histologically or cytologically confirmed gastric carcinoma, including gastric or gastroesophageal-junction adenocarcinoma.
  • Measurable disease (revised RECIST) based on computed tomography, or nonmeasurable disease
  • Previously untreated, unresectable advanced (M0) or unresectable metastatic (M1) disease except for prior adjuvant (or neo-adjuvant) chemotherapy.
  • ECOG performance status 0 or 1
  • At least 4 weeks and recovery from effects of prior major surgery
  • Adequate bone marrow, hepatic, and renal function

Primary Exclusion Criteria:

  • Operable gastric or gastroesophageal-junction cancer
  • Known brain metastasis
  • Second cancer
  • Previous adjuvant or neo-adjuvant chemotherapy with capecitabine and cisplatin in combination. (Previous adjuvant or neo-adjuvant monotherapy with capecitabine or S-1 or therapy with S-1 and cisplatin in combination or 5-FU and cisplatin in combination is allowed.)
  • Uncontrolled diarrhea
  • Nausea or vomiting for at least 3 consecutive days within the 14 days prior to registration despite the administration of standard antiemetic therapy
  • Symptomatic peripheral neuropathy ≥ Grade 2
  • Malabsorption syndrome or other disease that significantly affects gastrointestinal function
  • Other uncontrolled systemic illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tesetaxel-capecitabine-cisplatin
Drug: Tesetaxel-capecitabine-cisplatin

Phase 1: Tesetaxel orally on Day 1 of each cycle at dose of 18, 21, 24, or 27 mg/m2. If no dose-limiting toxicity, at least 3 subjects will be treated at each dose level until the maximum tolerated dose or the maximum dose of 27 mg/m2 is reached. At each tesetaxel dose level, capecitabine orally at a dose of 2000 mg/m2/day (administered in 2 equally divided doses) on Day 1-Day 14 and cisplatin intravenously at a dose of 60 mg/m2 on Day 1.

Phase 2: Tesetaxel orally on Day 1 of each cycle at dose determined in Phase 1. Capecitabine orally at a dose of 2000 mg/m2/day (administered in 2 equally divided doses) on Day 1-Day 14 and cisplatin intravenously at a dose of 60 mg/m2 on Day 1.

Other Names:
  • CDDP
  • Xeloda
  • Platinol
  • Platinol-AQ
  • DJ-927

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival rate (in Phase 2 portion of study)
Time Frame: 6 months from the date of first dose of study medication
6 months from the date of first dose of study medication

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recommended dose of tesetaxel for Phase 2 (in Phase 1 portion of study)
Time Frame: Up to 21 days after first dose of study medication
The dose of tesetaxel in mg/m2 will be determined for Phase 2 based on the occurrence of dose-limiting toxicities in Phase 1.
Up to 21 days after first dose of study medication
Response rate, as defined in revised RECIST (in Phase 2 portion of study)
Time Frame: Up to 12 months following the date of first dose of study medication
Up to 12 months following the date of first dose of study medication
Duration of response (in Phase 2 portion of study)
Time Frame: Up to 12 months following the date of first dose of study medication
Up to 12 months following the date of first dose of study medication
Rate of responses at least 3 months in duration (in Phase 2 portion of study)
Time Frame: Up to 12 months following the date of first dose of study medication
Up to 12 months following the date of first dose of study medication
Disease control rate, which is defined as the percentage of patients with a response of any duration or stable disease at least 6 weeks in duration (in Phase 2 portion of study)
Time Frame: Up to 12 months following the date of first dose of study medication
Up to 12 months following the date of first dose of study medication
Durable response rate, which is defined as the percentage of patients with a response at least 6 months in duration (in Phase 2 portion of study)
Time Frame: Up to 12 months following the date of first dose of study medication
Up to 12 months following the date of first dose of study medication
Progression-free survival (in Phase 2 portion of study)
Time Frame: Up to 12 months following the date of first dose of study medication
Up to 12 months following the date of first dose of study medication
Overall survival (in Phase 2 portion of study)
Time Frame: Up to 12 months following the date of first dose of study medication
Up to 12 months following the date of first dose of study medication
Percentage of patients with adverse events (in Phase 1 and Phase 2 portions)
Time Frame: Up to 30 days after the last dose of study medication
Up to 30 days after the last dose of study medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genta Incorporated

Investigators

  • Principal Investigator: Sun Young Rha, MD, PhD, Yonsei Cancer Center, Yonsei University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

January 1, 2014

Study Registration Dates

First Submitted

April 18, 2011

First Submitted That Met QC Criteria

May 3, 2011

First Posted (Estimate)

May 5, 2011

Study Record Updates

Last Update Posted (Estimate)

March 13, 2012

Last Update Submitted That Met QC Criteria

March 11, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOPK105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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