E7050 in Combination With Cisplatin and Capecitabine Versus Cisplatin and Capecitabine Alone in Patients With Advanced or Metastatic Solid Tumors and Previously Untreated Gastric Cancer

Stopped early · Phase 1/Phase 2

Conditions studied: Advanced or Metastatic Solid Tumors, Previously Untreated Gastric Cancer

In brief

The purpose of this study is to determine the following: 1. Find the maximum tolerated dose of E7050 when given in combination with cisplatin and capecitabine in patients with advance or metastatic solid tumors, and 2) Whether E7050 in combination with cisplatin and capecitabine is more effective in patients with previously untreated gastric cancer versus cisplatin and capecitabine alone.

Key facts

Study ID

NCT01355302

Run by

Eisai Inc.

People needed

7

Starts

2011-11-01

Expected to finish

2013-07-01

Last updated by the study team

2017-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed, unresectable, locally advanced or metastatic gastric cancer, including adenocarcinoma of the gastroesophageal junction (Phase II). For the Phase Ib portion, any unresectable, locally advanced or metastatic solid tumor;
• ECOG PS of 0-1;
• Blood pressure must be well-controlled. Patients must have no history of hypertensive crisis or hypertensive encephalopathy; Adequate end organ function

You may not qualify if…

• Gastric cancer patients who have had a complete gastrectomy;
• Patients with known HER2 over-expressing advanced or metastatic gastric cancer;
• Previously received E7050, its chemical derivatives, anti-cMet, anti-angiogenic therapy, (prior anti-angiogenic therapy is permitted in Phase Ib only).
• For Phase Ib prior systemic therapy is allowed as long as PS and end organ function meet entry criteria;
• For Phase II no prior palliative chemotherapy is permitted. Adjuvant/neoadjuvant chemotherapy is permitted if less than 12 months have elapsed between the end of adjuvant/neoadjuvant therapy and first recurrence;
• Known central nervous system lesions, except for asymptomatic non-progressing, treated brain metastases. Treatment for brain mets, but have been completed at least 4 weeks prior to Day 1
• Palliative radiotherapy is not permitted throughout the study period. Prior palliative radiotherapy within 30 days prior to commencing study treatment;
• Clinically significant hemoptysis;
• Patients with known dihydropyrimidine dehydrogenase deficiency;
• Patients with clinically significant hearing loss that may be further diminished by treatment with cisplatin plus capecitabine (significance of hearing loss to be determined by the Investigator;
• Serious non-healing wound, ulcer, or active bone fracture;
• Major surgical procedure, open biopsy, or significant traumatic injury within the 21 days prior to commencing study treatment;
• Clinically significant gastrointestinal bleeding within 6 months prior to first dose.

Where it is running

• Arizona Oncology Associates, PC - CASA — Tucson, Arizona, United States
• Boca Raton Clinical Research Associates, Inc — Plantation, Florida, United States
• Robert H. Lurie Comprenhensive Cancer Center of Northwestern University — Chicago, Illinois, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Henry Ford Medical Center — Detroit, Michigan, United States
• University of North Carolina at Chapel Hill — Chapell Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Mercy Cancer Centerr at St. Anne — Toledo, Ohio, United States
• Chelyabinsk Regional Oncology Dispensary — Chelyabinsk, Russia
• GOU VPO St-Petersburg SMA n/a Mechnikov Fed. Agen. of Healthcare and Social Developm. — Saint Petersburg, Russia
• FSI "SRC of Oncology n. a. N.N.Petrov of Rosmedtekhnologiy" — Saint Petersburg, Russia
• SI Dnipropetrovsk Medical Academy of MOHU ch of Oncology and Medical Radiology — Dnipropetrovsk, Ukraine
• Municipal Clinical Medical and Prophylactic Institution Donetsk Regional Antitumor Centre — Donetsk, Ukraine
• Kyiv City Clinical Oncological Center — Kyiv, Ukraine
• Lviv State Oncol. Reg. Treatment and Diagnostic Center — Lviv, Ukraine
• Barts and the London NHS Trust — London, Greater London, United Kingdom
• Sarah Cannon Research UK — London, Greater London, United Kingdom
• The Christie NHS Foundation Trust — Manchester, Greater Manchester, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.