Capecitabine/Tesetaxel Versus Capecitabine/Placebo as Second-line Therapy for Gastric Cancer

Phase 2

• Conditions: Gastric Carcinoma
• Interventions: Drug: Placebo; Drug: Tesetaxel; Drug: Capecitabine

• Registration Number: NCT01573468
• Lead Sponsor: Genta Incorporated

Brief Summary

This study is being performed to evaluate the efficacy and safety of capecitabine in combination with tesetaxel versus capecitabine in combination with placebo as second-line treatment for patients with gastric cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-05
• Study First Submitted QC: 2012-04-06
• Study First Posted: 2012-04-09
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-20
• Last Update Posted: 2012-07-24
• Primary Completion: 2014-07
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 580

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Capecitabine-placebo	Placebo	21-day cycle; placebo orally once on Day 1; capecitabine 1750 mg/m2/day orally in 2 equally divided doses on Days 1-14
Capecitabine-tesetaxel	Capecitabine	21-day cycle; tesetaxel 27 mg/m2 orally once on Day 1; capecitabine 1750 mg/m2/day orally in 2 equally divided doses on Days 1-14
Capecitabine-placebo	Capecitabine	21-day cycle; placebo orally once on Day 1; capecitabine 1750 mg/m2/day orally in 2 equally divided doses on Days 1-14
Capecitabine-tesetaxel	Tesetaxel	21-day cycle; tesetaxel 27 mg/m2 orally once on Day 1; capecitabine 1750 mg/m2/day orally in 2 equally divided doses on Days 1-14

Primary Outcome Measures

Name	Time	Method
Overall survival	When at least 508 events of death have occurred, which is estimated will occur 12 months after the date of randomization of the last patient

Secondary Outcome Measures

Name	Time	Method
Disease control rate	Estimated will be assessed 12 months after the date of randomization of the last patient	The percentages of patients with complete or partial response of any duration or stable disease lasting at least 6 weeks from the date of randomization (revised RECIST)
Progression-free survival	Estimated will be assessed 12 months after the date of randomization of the last patient	Calculated from the date of randomization to the date when disease progression is first documented or when the patient dies within 60 days of the last lesion assessment
Response rate in patients with measurable disease	Estimated will be assessed 12 months after the date of randomization of the last patient	The percentages of patients with complete or partial response (revised RECIST)
Incidence of adverse events	Through 30 days after the last dose of study medication	The percentages of patients who experience adverse events by specific adverse event term

Trial Locations

Locations (3)

Krankenhaus Nordwest; 🇩🇪 Frankfurt, Germany

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan