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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Genta Incorporated.
Recruitment status was  Recruiting
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

April 5, 2012
July 20, 2012
April 2012
July 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01573468 on ClinicalTrials.gov Archive Site
  • 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
  • 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 (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 (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
Not Provided
Not Provided
 
Capecitabine/Tesetaxel Versus Capecitabine/Placebo as Second-line Therapy for Gastric Cancer
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Gastric Carcinoma
  • Drug: Tesetaxel
    Tesetaxel 27 mg/m2 orally once on Day 1 of each cycle
  • 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
  • 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
    Interventions:
    • Drug: Tesetaxel
    • Drug: Capecitabine
  • 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
    Interventions:
    • Drug: Placebo
    • Drug: Capecitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
580
August 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Mansoor Ahmad, MD, PhD 908 286-3113 medinfo@genta.com
United States,   Germany,   Taiwan
 
NCT01573468
TOG301, 2010-022164-12
Yes
Genta Incorporated
Genta Incorporated
Not Provided
Study Chair: Jaffer Ajani, MD The University of Texas MD Anderson Cancer Center
Genta Incorporated
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP