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An Open-Label, Multicenter, Randomized, Phase Ib/II Study of 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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Advanced or Metastatic Solid Tumors, Previously Untreated Gastric Cancer

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Trial Information

An Open-Label, Multicenter, Randomized, Phase Ib/II Study of 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


This open-label, multicenter, randomized study will consist of 2 phases:

Phase Ib: a safety run-in period with 3 ascending doses of E7050 in combination with fixed
doses of Cisplatin and Capecitabine. This phase will enroll approximately 10 to 15 patients.

•Phase II: a randomized 2-arm design which will enroll 80 patients.

In the phase II portion, Patients will receive study treatment , E7050 in combination with
Cisplatin and Capecitabine versus Cisplatin and Capecitabine Alone) for approximately six
21-day cycles (18 weeks). Beyond 18 weeks, patients who are experiencing clinical benefit
may continue E7050, with or without Capecitabine (Arm 1), or may continue Capecitabine alone
(Arm 2), depending on the original randomization treatment arm. Patients will continue
treatment for as long as clinical benefit is sustained and the treatment is well tolerated,
until the occurrence of progressive disease (PD), unacceptable toxicity, withdrawal of
consent, or withdrawal by investigator, whichever occurs first. Patients will participate in
either phase Ib or phase II.

Inclusion Criteria


Inclusion Criteria

- 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

Exclusion Criteria

- 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 >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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety parameter:adverse events

Outcome Description:

Phase Ib: to determine the MTD/recommended Phase II dose and characterize the pharmacokinetics (PK) of E7050 when administered in combination with Cisplatin and Capecitabine versus Cisplatin and Capecitabine Alone in Patients with Advanced or Metastatic Solid Tumors •Phase II: to evaluate the safety and tolerability of E7050 administered in combination with Cisplatin and Capecitabine versus Cisplatin and Capecitabine Alone in Patients with Previously Untreated Gastric Cancer.

Outcome Time Frame:

until study termination; 3 years

Safety Issue:

Yes

Principal Investigator

Melissa Versola

Investigator Role:

Study Director

Investigator Affiliation:

Quintiles

Authority:

United States: Food and Drug Administration

Study ID:

E7050-703

NCT ID:

NCT01355302

Start Date:

November 2011

Completion Date:

July 2013

Related Keywords:

  • Advanced or Metastatic Solid Tumors
  • Previously Untreated Gastric Cancer
  • Cancer
  • Solid Tumors
  • Gastric
  • Phase I
  • Phase II
  • Stomach Neoplasms
  • Neoplasms

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Duke University Medical CenterDurham, North Carolina  27710
University of North Carolina at Chapel HillChapel Hill, North Carolina  27599
Henry Ford Medical CenterDearborn, Michigan  48126
Arizona Oncology Associates, PC - CASATucson, Arizona  85715
Boca Raton Clinical Research Associates, IncPlantation, Florida  33324
Robert H. Lurie Comprenhensive Cancer Center of Northwestern UniversityChicago, Illinois  60611
Mercy Cancer Centerr at St. AnneToledo, Ohio  43623