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

• Sponsor: Genta Incorporated (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT01573468
• Collaborator: (none)
• Enrollment: 580
• Locations: 3
• Arms: 2
• Duration (Months): 28
• Patients Per Site: 193.3
• Patients Per Site Per Month: 6.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Carcinoma	Drug: Tesetaxel; Drug: Placebo; Drug: Capecitabine	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 580 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind Study of Capecitabine Plus Tesetaxel Versus Capecitabine Plus Placebo as Second-line Therapy in Subjects With Gastric Cancer
• Study Start Date: Apr 1, 2012
• Anticipated Primary Completion Date: Jul 1, 2014
• Anticipated Study Completion Date: Aug 1, 2014

Arms and Interventions

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: Placebo; Placebo 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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

2. 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

3. 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)

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030
2	Krankenhaus Nordwest	Frankfurt		Germany	60488
3	National Cheng Kung University Hospital	Tainan		Taiwan	704

Sponsors and Collaborators

• Genta Incorporated

Investigators

• Study Chair: Jaffer Ajani, MD, The University of Texas MD Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Genta Incorporated
• ClinicalTrials.gov Identifier: NCT01573468
• Other Study ID Numbers: TOG301; 2010-022164-12
• First Posted: Apr 9, 2012
• Last Update Posted: Jul 24, 2012
• Last Verified: Jul 1, 2012

• Additional relevant MeSH terms: Stomach Neoplasms; Capecitabine

Study Results

No Results Posted as of Jul 24, 2012