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Tesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Genta Incorporated.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01348009
First Posted: May 5, 2011
Last Update Posted: March 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genta Incorporated
  Purpose

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 Intervention Phase
Gastric Carcinoma Drug: Tesetaxel-capecitabine-cisplatin Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Genta Incorporated:

Primary Outcome Measures:
  • Progression-free survival rate (in Phase 2 portion of study) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Up to 12 months following the date of first dose of study medication ]
  • Duration of response (in Phase 2 portion of study) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Up to 12 months following the date of first dose of study medication ]
  • Progression-free survival (in Phase 2 portion of study) [ Time Frame: Up to 12 months following the date of first dose of study medication ]
  • Overall survival (in Phase 2 portion of study) [ Time Frame: 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) [ Time Frame: Up to 30 days after the last dose of study medication ]

Estimated Enrollment: 63
Study Start Date: May 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01348009


Locations
Korea, Republic of
Yonsei Cancer Center, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of
Contact: Sun Young Rha, MD    82-2-2228-8050      
Principal Investigator: Sun Young Rha, MD, PhD         
Sponsors and Collaborators
Genta Incorporated
Investigators
Principal Investigator: Sun Young Rha, MD, PhD Yonsei Cancer Center, Yonsei University College of Medicine
  More Information

Responsible Party: Genta Incorporated
ClinicalTrials.gov Identifier: NCT01348009     History of Changes
Other Study ID Numbers: TOPK105
First Submitted: April 18, 2011
First Posted: May 5, 2011
Last Update Posted: March 13, 2012
Last Verified: March 2012

Keywords provided by Genta Incorporated:
Gastric cancer
First-line therapy
Tesetaxel
Taxane
Capecitabine
Oral fluoropyrimidine
Cisplatin
Platinum

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Cisplatin
Capecitabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action


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