Tesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer
This study is currently recruiting participants.
Verified March 2012 by Genta Incorporated
Sponsor:
Genta Incorporated
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
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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:
|
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
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 Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 19, 2013