Tesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer

Sponsor

Genta Incorporated (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01348009

Collaborator

(none)

Enrollment

Location

Arm

32.1

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Carcinoma	Drug: Tesetaxel-capecitabine-cisplatin	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

63 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I-II Study of Tesetaxel Plus Capecitabine and Cisplatin in Subjects With Advanced Gastric Cancer

Study Start Date :

May 1, 2011

Anticipated Primary Completion Date :

Oct 1, 2013

Anticipated Study Completion Date :

Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tesetaxel-capecitabine-cisplatin	Drug: Tesetaxel-capecitabine-cisplatin 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. Other Names: DJ-927 Xeloda CDDP Platinol Platinol-AQ

Arm

Intervention/Treatment

Experimental: Tesetaxel-capecitabine-cisplatin

Drug: Tesetaxel-capecitabine-cisplatin

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.

Other Names:

DJ-927

Xeloda

CDDP

Platinol

Platinol-AQ

Outcome Measures

Primary Outcome Measures

Progression-free survival rate (in Phase 2 portion of study) [6 months from the date of first dose of study medication]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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