Tesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer

NCT01348009 | Unknown Phase 1 DMC

• 1 other identifier: TOPK105
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Cisplatin, an intravenously administered platinum agent, in combination with an intravenously administered taxane and capecitabine has been shown to improve time to disease progression and overall survival in previously untreated patients with gastric cancer. This study is being performed to evaluate an orally administered taxane (tesetaxel) in combination with cisplatin and capecitabine in previously untreated patients with gastric cancer.

Conditions

Gastric Carcinoma

Keywords

Gastric cancer; First-line therapy; Tesetaxel; Taxane; Capecitabine; Oral fluoropyrimidine; Cisplatin; Platinum

Outcome Measures

Primary Outcomes (1)

• Progression-free survival rate (in Phase 2 portion of study)

  6 months from the date of first dose of study medication

Secondary Outcomes (9)

• Recommended dose of tesetaxel for Phase 2 (in Phase 1 portion of study)

  Up to 21 days after first dose of study medication

• Response rate, as defined in revised RECIST (in Phase 2 portion of study)

  Up to 12 months following the date of first dose of study medication

• Duration of response (in Phase 2 portion of study)

  Up to 12 months following the date of first dose of study medication

• Rate of responses at least 3 months in duration (in Phase 2 portion of study)

  Up to 12 months following the date of first dose of study medication

• Disease control rate, which is defined as the percentage of patients with a response of any duration or stable disease at least 6 weeks in duration (in Phase 2 portion of study)

  Up to 12 months following the date of first dose of study medication

Study Arms (1)

Tesetaxel-capecitabine-cisplatin

EXPERIMENTAL

Drug: Tesetaxel-capecitabine-cisplatin

Interventions

Tesetaxel-capecitabine-cisplatin DRUG

Phase 1: Tesetaxel orally on Day 1 of each cycle at dose of 18, 21, 24, or 27 mg/m2. If no dose-limiting toxicity, at least 3 subjects will be treated at each dose level until the maximum tolerated dose or the maximum dose of 27 mg/m2 is reached. At each tesetaxel dose level, capecitabine orally at a dose of 2000 mg/m2/day (administered in 2 equally divided doses) on Day 1-Day 14 and cisplatin intravenously at a dose of 60 mg/m2 on Day 1. Phase 2: Tesetaxel orally on Day 1 of each cycle at dose determined in Phase 1. Capecitabine orally at a dose of 2000 mg/m2/day (administered in 2 equally divided doses) on Day 1-Day 14 and cisplatin intravenously at a dose of 60 mg/m2 on Day 1.

Also known as: DJ-927, Xeloda, CDDP, Platinol, Platinol-AQ

Tesetaxel-capecitabine-cisplatin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 20 years of age
• Histologically or cytologically confirmed gastric carcinoma, including gastric or gastroesophageal-junction adenocarcinoma.
• Measurable disease (revised RECIST) based on computed tomography, or nonmeasurable disease
• Previously untreated, unresectable advanced (M0) or unresectable metastatic (M1) disease except for prior adjuvant (or neo-adjuvant) chemotherapy.
• ECOG performance status 0 or 1
• At least 4 weeks and recovery from effects of prior major surgery
• Adequate bone marrow, hepatic, and renal function

You may not qualify if:

• Operable gastric or gastroesophageal-junction cancer
• Known brain metastasis
• Second cancer
• Previous adjuvant or neo-adjuvant chemotherapy with capecitabine and cisplatin in combination. (Previous adjuvant or neo-adjuvant monotherapy with capecitabine or S-1 or therapy with S-1 and cisplatin in combination or 5-FU and cisplatin in combination is allowed.)
• Uncontrolled diarrhea
• Nausea or vomiting for at least 3 consecutive days within the 14 days prior to registration despite the administration of standard antiemetic therapy
• Symptomatic peripheral neuropathy ≥ Grade 2
• Malabsorption syndrome or other disease that significantly affects gastrointestinal function
• Other uncontrolled systemic illness

Sponsors & Collaborators

• Genta Incorporated: lead

Study Sites (1)

Yonsei Cancer Center, Yonsei University College of Medicine

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

tesetaxel; Capecitabine; Cisplatin

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; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Sun Young Rha, MD, PhD

  Yonsei Cancer Center, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2011
• First Posted: May 5, 2011
• Study Start: May 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: January 1, 2014
• Last Updated: March 13, 2012

Record last verified: 2012-03

Locations

KR (1)