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

A Randomized, Double-blind Study of Capecitabine Plus Tesetaxel Versus Capecitabine Plus Placebo as Second-line Therapy in Subjects With Gastric Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Gastric Carcinoma
• Intervention / Treatment: Drug: Tesetaxel; Drug: Capecitabine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 580
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Frankfurt, Germany, 60488
    • Recruiting
    • Krankenhaus Nordwest
    • Contact: Salah-Eddin Al-Batran, PD Dr. med; Phone Number: +49 (0) 69 7601 4420
    • Principal Investigator: Salah-Eddin Al-Batran, PD Dr. med
• Taiwan
  • Tainan, Taiwan, 704
    • Recruiting
    • National Cheng Kung University Hospital
    • Contact: Chia-Jui Yen, MD; Phone Number: +886 6 2353535 4620
    • Principal Investigator: Chia-Jui Yen, MD
• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas MD Anderson Cancer Center
      • Principal Investigator: Jaffer Ajani, MD
      • Contact: Jaffer Ajani, MD; Phone Number: 713-745-3917

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key inclusion criteria:

1. Histologically or cytologically confirmed gastric adenocarcinoma, including gastric or gastroesophageal-junction adenocarcinoma (Histologically confirmed adenocarcinoma of the lower esophagus acceptable with radiographic or endoscopic documentation of gastroesophageal-junction or proximal-stomach involvement.)
2. Measurable disease (revised RECIST) based on computed tomography, or nonmeasurable disease
3. ECOG performance status 0 or 1
4. Treatment with only 1 prior regimen (as first-line therapy) that must have included a fluoropyrimidine and a platinum-containing agent (Prior adjuvant or neo-adjuvant chemotherapy acceptable provided 6 months elapsed between the end of this therapy and the start of first-line therapy.)
5. Disease progression after the start of the 1 prior regimen based on computed tomography
6. Adequate bone marrow, hepatic, and renal function
7. Ability to swallow an oral solid-dosage form of medication

Key exclusion criteria:

1. Squamous cell gastric carcinoma
2. Bone-only metastatic disease
3. History or presence of brain metastasis or leptomeningeal disease
4. Operable gastric or gastroesophageal-junction cancer
5. HER2-positive disease if the patient has not previously been treated with an anti-HER2 agent
6. Uncontrolled diarrhea, nausea, or vomiting
7. Known malabsorptive disorder
8. Significant medical disease other than gastric cancer
9. Presence of neuropathy > Grade 1 (NCI Common Toxicity Criteria)
10. Prior treatment (including adjuvant therapy) with a taxane or other tubulin-targeted agent (indibulin, eribulin, etc.)
11. Prior radiation therapy to more than 25% of the bone marrow
12. Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway
13. Pregnancy or lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Capecitabine-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	Drug: Tesetaxel; Tesetaxel 27 mg/m2 orally once on Day 1 of each cycle; Drug: Capecitabine; Capecitabine 1750 mg/m2/day orally twice daily (in 2 equally divided doses) on Days 1-14 of each cycle; Other Names: Xeloda
Active Comparator: Capecitabine-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	Drug: Capecitabine; Capecitabine 1750 mg/m2/day orally twice daily (in 2 equally divided doses) on Days 1-14 of each cycle; Other Names: Xeloda; Drug: Placebo; Placebo orally once on Day 1 of each cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Disease control rate	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)	Estimated will be assessed 12 months after the date of randomization of the last patient
Progression-free survival	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	Estimated will be assessed 12 months after the date of randomization of the last patient
Response rate in patients with measurable disease	The percentages of patients with complete or partial response (revised RECIST)	Estimated will be assessed 12 months after the date of randomization of the last patient
Incidence of adverse events	The percentages of patients who experience adverse events by specific adverse event term	Through 30 days after the last dose of study medication

Collaborators and Investigators

• Sponsor: Genta Incorporated
• Investigators: Study Chair: Jaffer Ajani, MD, The University of Texas MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Anticipated): July 1, 2014
• Study Completion (Anticipated): August 1, 2014

Study Registration Dates

• First Submitted: April 5, 2012
• First Submitted That Met QC Criteria: April 6, 2012
• First Posted (Estimate): April 9, 2012

Study Record Updates

• Last Update Posted (Estimate): July 24, 2012
• Last Update Submitted That Met QC Criteria: July 20, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine
• Other Study ID Numbers: TOG301; 2010-022164-12 (EudraCT Number)