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Trial Title: Tesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer

NCT ID: NCT01348009

Condition: Gastric Carcinoma

Conditions: Official terms:
Stomach Neoplasms
Cisplatin
Capecitabine

Conditions: Keywords:
Gastric cancer
First-line therapy
Tesetaxel
Taxane
Capecitabine
Oral fluoropyrimidine
Cisplatin
Platinum

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Unknown status

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Tesetaxel-capecitabine-cisplatin
Description: 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.
Arm group label: Tesetaxel-capecitabine-cisplatin

Other name: DJ-927

Other name: Xeloda

Other name: CDDP

Other name: Platinol

Other name: Platinol-AQ

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.

Criteria for eligibility:
Criteria:
Primary Inclusion Criteria: - 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 Primary Exclusion Criteria: - 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

Gender: All

Minimum age: 20 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Yonsei Cancer Center, Yonsei University College of Medicine

Address:
City: Seoul
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Sun Young Rha, MD

Phone: 82-2-2228-8050

Investigator:
Last name: Sun Young Rha, MD, PhD
Email: Principal Investigator

Start date: May 2011

Completion date: January 2014

Lead sponsor:
Agency: Genta Incorporated
Agency class: Industry

Source: Genta Incorporated

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01348009

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