Tesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer

This study is currently recruiting participants.

Verified March 2012 by Genta Incorporated

Sponsor:

Information provided by (Responsible Party):

Genta Incorporated

ClinicalTrials.gov Identifier:

NCT01348009

First received: April 18, 2011

Last updated: March 11, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 18, 2011

Last Updated Date

March 11, 2012

Start Date ^ICMJE

May 2011

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Progression-free survival rate (in Phase 2 portion of study) [ Time Frame: 6 months from the date of first dose of study medication ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01348009 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Recommended dose of tesetaxel for Phase 2 (in Phase 1 portion of study) [ Time Frame: Up to 21 days after first dose of study medication ] [ Designated as safety issue: Yes ]
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) [ Time Frame: Up to 12 months following the date of first dose of study medication ] [ Designated as safety issue: No ]
Duration of response (in Phase 2 portion of study) [ Time Frame: Up to 12 months following the date of first dose of study medication ] [ Designated as safety issue: No ]
Rate of responses at least 3 months in duration (in Phase 2 portion of study) [ Time Frame: Up to 12 months following the date of first dose of study medication ] [ Designated as safety issue: No ]
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) [ Time Frame: Up to 12 months following the date of first dose of study medication ] [ Designated as safety issue: No ]
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) [ Time Frame: Up to 12 months following the date of first dose of study medication ] [ Designated as safety issue: No ]
Progression-free survival (in Phase 2 portion of study) [ Time Frame: Up to 12 months following the date of first dose of study medication ] [ Designated as safety issue: No ]
Overall survival (in Phase 2 portion of study) [ Time Frame: Up to 12 months following the date of first dose of study medication ] [ Designated as safety issue: No ]
Percentage of patients with adverse events (in Phase 1 and Phase 2 portions) [ Time Frame: Up to 30 days after the last dose of study medication ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Tesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Gastric Carcinoma

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Tesetaxel-capecitabine-cisplatin

Intervention: Drug: Tesetaxel-capecitabine-cisplatin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2014

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01348009

Other Study ID Numbers ^ICMJE

TOPK105

Has Data Monitoring Committee

Yes

Responsible Party

Genta Incorporated

Study Sponsor ^ICMJE

Genta Incorporated

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Sun Young Rha, MD, PhD

Yonsei Cancer Center, Yonsei University College of Medicine

Information Provided By

Genta Incorporated

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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