Tesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer
Phase 1
- Conditions
- Gastric Carcinoma
- Interventions
- Drug: Tesetaxel-capecitabine-cisplatin
- Registration Number
- NCT01348009
- Lead Sponsor
- Genta Incorporated
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 63
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tesetaxel-capecitabine-cisplatin Tesetaxel-capecitabine-cisplatin -
- Primary Outcome Measures
Name Time Method Progression-free survival rate (in Phase 2 portion of study) 6 months from the date of first dose of study medication
- Secondary Outcome Measures
Name Time Method Recommended dose of tesetaxel for Phase 2 (in Phase 1 portion of study) Up to 21 days after first dose of study medication The dose of tesetaxel in mg/m2 will be determined for Phase 2 based on the occurrence of dose-limiting toxicities in Phase 1.
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 Durable response rate, which is defined as the percentage of patients with a response at least 6 months in duration (in Phase 2 portion of study) Up to 12 months following the date of first dose of study medication Progression-free survival (in Phase 2 portion of study) Up to 12 months following the date of first dose of study medication Overall survival (in Phase 2 portion of study) Up to 12 months following the date of first dose of study medication Percentage of patients with adverse events (in Phase 1 and Phase 2 portions) Up to 30 days after the last dose of study medication
Trial Locations
- Locations (1)
Yonsei Cancer Center, Yonsei University College of Medicine
🇰🇷Seoul, Korea, Republic of