Tesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Genta Incorporated.
Recruitment status was  Recruiting
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
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ 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 ]

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Genta Incorporated
ClinicalTrials.gov Identifier: NCT01348009     History of Changes
Other Study ID Numbers: TOPK105
Study First Received: April 18, 2011
Last Updated: March 11, 2012
Health Authority: United States: Food and Drug Administration
Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Carcinoma
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014