Tesetaxel Plus Capecitabine and Cisplatin in Advanced Gastric Cancer

Gastric Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01348009
• Other study ID #: TOPK105
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: April 18, 2011
• Last updated: March 11, 2012
• Start date: May 2011
• Est. completion date: January 2014

Study information

• Verified date: March 2012
• Source: Genta Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationKorea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: January 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Gastric Carcinoma
• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei Cancer Center, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Genta Incorporated

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival rate (in Phase 2 portion of study)		6 months from the date of first dose of study medication	No
Secondary	Recommended dose of tesetaxel for Phase 2 (in Phase 1 portion of study)	The dose of tesetaxel in mg/m2 will be determined for Phase 2 based on the occurrence of dose-limiting toxicities in Phase 1.	Up to 21 days after first dose of study medication	Yes
Secondary	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	No
Secondary	Duration of response (in Phase 2 portion of study)		Up to 12 months following the date of first dose of study medication	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Progression-free survival (in Phase 2 portion of study)		Up to 12 months following the date of first dose of study medication	No
Secondary	Overall survival (in Phase 2 portion of study)		Up to 12 months following the date of first dose of study medication	No
Secondary	Percentage of patients with adverse events (in Phase 1 and Phase 2 portions)		Up to 30 days after the last dose of study medication	Yes