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

NCT01573468 | Unknown Phase 2 DMC

• 2 other identifiers: TOG3012010-022164-12
• Study Type: interventional
• Target: 580
• Locations: 3 countries
• Sites: 3

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.

Conditions

Gastric Carcinoma

Outcome Measures

Primary Outcomes (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 Outcomes (4)

• Disease control rate

  Estimated will be assessed 12 months after the date of randomization of the last patient

• Progression-free survival

  Estimated will be assessed 12 months after the date of randomization of the last patient

• Response rate in patients with measurable disease

  Estimated will be assessed 12 months after the date of randomization of the last patient

• Incidence of adverse events

  Through 30 days after the last dose of study medication

Study Arms (2)

Capecitabine-tesetaxel

EXPERIMENTAL

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; Drug: Capecitabine

Capecitabine-placebo

ACTIVE COMPARATOR

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; Drug: Capecitabine

Interventions

Tesetaxel DRUG

Tesetaxel 27 mg/m2 orally once on Day 1 of each cycle

Capecitabine-tesetaxel

Placebo DRUG

Placebo orally once on Day 1 of each cycle

Capecitabine-placebo

Capecitabine DRUG

Capecitabine 1750 mg/m2/day orally twice daily (in 2 equally divided doses) on Days 1-14 of each cycle

Also known as: Xeloda

Capecitabine-placebo; Capecitabine-tesetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)
• Measurable disease (revised RECIST) based on computed tomography, or nonmeasurable disease
• ECOG performance status 0 or 1
• 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.)
• Disease progression after the start of the 1 prior regimen based on computed tomography
• Adequate bone marrow, hepatic, and renal function
• Ability to swallow an oral solid-dosage form of medication

You may not qualify if:

• Squamous cell gastric carcinoma
• Bone-only metastatic disease
• History or presence of brain metastasis or leptomeningeal disease
• Operable gastric or gastroesophageal-junction cancer
• HER2-positive disease if the patient has not previously been treated with an anti-HER2 agent
• Uncontrolled diarrhea, nausea, or vomiting
• Known malabsorptive disorder
• Significant medical disease other than gastric cancer
• Presence of neuropathy \> Grade 1 (NCI Common Toxicity Criteria)
• Prior treatment (including adjuvant therapy) with a taxane or other tubulin-targeted agent (indibulin, eribulin, etc.)
• Prior radiation therapy to more than 25% of the bone marrow
• Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway
• Pregnancy or lactation

Sponsors & Collaborators

• Genta Incorporated: lead

Study Sites (3)

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Krankenhaus Nordwest

Frankfurt, 60488, Germany

RECRUITING

National Cheng Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

tesetaxel; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jaffer Ajani, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Central Study Contacts

Mansoor Ahmad, MD, PhD

CONTACT

908 286-3113; medinfo@genta.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2012
• First Posted: April 9, 2012
• Study Start: April 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: August 1, 2014
• Last Updated: July 24, 2012

Record last verified: 2012-07

Locations

DE (1); TW (1); US (1)