Clinical trial NCT01573468: Capecitabine/Tesetaxel Versus Capecitabine/Placebo as Second-line Therapy for Gastric Cancer
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Carcinoma
Lead sponsor: Genta Incorporated
Sponsor class: INDUSTRY
First posted: 2012-04-09
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Overall survival
timeFrame: 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 outcomes:
measure: Disease control rate
timeFrame: Estimated will be assessed 12 months after the date of randomization of the last patient
measure: Progression-free survival
timeFrame: Estimated will be assessed 12 months after the date of randomization of the last patient
measure: Response rate in patients with measurable disease
timeFrame: Estimated will be assessed 12 months after the date of randomization of the last patient
measure: Incidence of adverse events
timeFrame: Through 30 days after the last dose of study medication
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: The University of Texas MD Anderson Cancer Center
name: Jaffer Ajani, MD
role: STUDY_CHAIR
References: