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

Gastric Carcinoma Clinical Trial

— TESEGAST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01573468
• Other study ID #: TOG301
• Secondary ID: 2010-022164-12
• Status: Recruiting
• Phase: Phase 2
• First received: April 5, 2012
• Last updated: July 20, 2012
• Start date: April 2012
• Est. completion date: August 2014

Study information

• Verified date: July 2012
• Source: Genta Incorporated
• Contact: Mansoor Ahmad, MD, PhD
• Phone: 908 286-3113
• Email: medinfo[@]genta.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesTaiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 580
• Est. completion date: August 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Carcinoma
• Stomach Neoplasms

Intervention

Drug:
• Tesetaxel
Tesetaxel 27 mg/m2 orally once on Day 1 of each cycle
• Placebo
Placebo orally once on Day 1 of each cycle
• Capecitabine
Capecitabine 1750 mg/m2/day orally twice daily (in 2 equally divided doses) on Days 1-14 of each cycle

Locations

Country	Name	City	State
Germany	Krankenhaus Nordwest	Frankfurt
Taiwan	National Cheng Kung University Hospital	Tainan
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Genta Incorporated

Countries where clinical trial is conducted

United States,  Germany,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes