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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Genta Incorporated
Sponsor:
Information provided by (Responsible Party):
Genta Incorporated
ClinicalTrials.gov Identifier:
NCT01573468
First received: April 5, 2012
Last updated: July 20, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Gastric Carcinoma
Drug: Tesetaxel
Drug: Placebo
Drug: Capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Genta Incorporated:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease control rate [ Time Frame: Estimated will be assessed 12 months after the date of randomization of the last patient ] [ Designated as safety issue: No ]
    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 [ Time Frame: Estimated will be assessed 12 months after the date of randomization of the last patient ] [ Designated as safety issue: No ]
    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 [ Time Frame: Estimated will be assessed 12 months after the date of randomization of the last patient ] [ Designated as safety issue: No ]
    The percentages of patients with complete or partial response (revised RECIST)

  • Incidence of adverse events [ Time Frame: Through 30 days after the last dose of study medication ] [ Designated as safety issue: Yes ]
    The percentages of patients who experience adverse events by specific adverse event term


Estimated Enrollment: 580
Study Start Date: April 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Xeloda

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573468

Contacts
Contact: Mansoor Ahmad, MD, PhD 908 286-3113 medinfo@genta.com

Locations
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jaffer Ajani, MD    713-745-3917      
Principal Investigator: Jaffer Ajani, MD         
Germany
Krankenhaus Nordwest Recruiting
Frankfurt, Germany, 60488
Contact: Salah-Eddin Al-Batran, PD Dr. med    +49 (0) 69 7601 4420      
Principal Investigator: Salah-Eddin Al-Batran, PD Dr. med         
Taiwan
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 704
Contact: Chia-Jui Yen, MD    +886 6 2353535 4620      
Principal Investigator: Chia-Jui Yen, MD         
Sponsors and Collaborators
Genta Incorporated
Investigators
Study Chair: Jaffer Ajani, MD The University of Texas MD Anderson Cancer Center
  More Information

No publications provided

Responsible Party: Genta Incorporated
ClinicalTrials.gov Identifier: NCT01573468     History of Changes
Other Study ID Numbers: TOG301, 2010-022164-12
Study First Received: April 5, 2012
Last Updated: July 20, 2012
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Taiwan : Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014