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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced or Metastatic Solid Tumors Previously Untreated Gastric Cancer |
Drug: E7050 Drug: cisplatin Drug: capecitabine |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
- Safety parameter:adverse events [ Time Frame: until study termination; 3 years ] [ Designated as safety issue: Yes ]
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.
- Safety parameter:Concomitant medications [ Time Frame: until study termination; 3 years ] [ Designated as safety issue: Yes ]
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.
- Safety parameter: lab tests [ Time Frame: Day 1 and every 21 days until study termination; 3 years ] [ Designated as safety issue: Yes ]
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.
- Safety parameter: ECGs [ Time Frame: Screening and 21 days after end of therapy; 3 years ] [ Designated as safety issue: Yes ]
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.
- Efficacy parameter: Overall response rate (ORR) [ Time Frame: Until disease progression or death for 3 years ] [ Designated as safety issue: No ]
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.
- Efficacy parameter: Time to progression (TTP) [ Time Frame: Until disease progression or death for 3 years ] [ Designated as safety issue: No ]
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
| Enrollment: | 7 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Phase Ib: Cohort 1, 2, and 3
Phase Ib: Cohort 1; 200 mg E7050 + 80 mg/m2 cisplatin + 1000 mg/m2 capecitabine Cohort 2; 300 mg E7050 + 80 mg/m2 cisplatin + 2000 mg/m2 capecitabine Cohort 3; 400 mg E7050 + 80 mg/m2 cisplatin + 2000 mg/m2 capecitabine |
Drug: E7050
E7050 given orally at either 200, 300, or 400 mg once daily.
|
|
Active Comparator: Phase II: Arm 1; E7050 + cisplatin+ capecitabine
Phase II: Arm 1; MTD E7050 + 80 mg/m2 cisplatin + 2000 mg/m2 capecitabine
|
Drug: cisplatin
Cisplatin will be administered at 80 mg/m2 by intravenous infusion over 60 minutes on Day 1 of each 21-day treatment cycle.
Drug: capecitabine
Capecitabine will be administered at 1000 mg/m2 orally, twice daily (2000 mg/m2 total daily dose) on Days 1 through 14 of each 21-day treatment cycle.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Arizona | |
| Arizona Oncology Associates, PC - CASA | |
| Tucson, Arizona, United States, 85715 | |
| United States, Florida | |
| Boca Raton Clinical Research Associates, Inc | |
| Plantation, Florida, United States, 33324 | |
| United States, Illinois | |
| Robert H. Lurie Comprenhensive Cancer Center of Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109 | |
| Henry Ford Medical Center | |
| Detroit, Michigan, United States, 48202 | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48084 | |
| United States, North Carolina | |
| University of North Carolina at Chapel Hill | |
| Chapell Hill, North Carolina, United States, 27599 | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Mercy Cancer Centerr at St. Anne | |
| Toledo, Ohio, United States, 43623 | |
| Russian Federation | |
| Chelyabinsk Regional Oncology Dispensary | |
| Chelyabinsk, Russian Federation, 454087 | |
| GOU VPO St-Petersburg SMA n/a Mechnikov Fed. Agen. of Healthcare and Social Developm. | |
| St Petersburg, Russian Federation, 195067 | |
| FSI "SRC of Oncology n. a. N.N.Petrov of Rosmedtekhnologiy" | |
| St Petersburg, Russian Federation, 197758 | |
| Ukraine | |
| SI Dnipropetrovsk Medical Academy of MOHU ch of Oncology and Medical Radiology | |
| Dnipropetrovsk, Ukraine, 49102 | |
| Municipal Clinical Medical and Prophylactic Institution Donetsk Regional Antitumor Centre | |
| Donetsk, Ukraine, 83092 | |
| Kyiv City Clinical Oncological Center | |
| Kyiv, Ukraine, 3115 | |
| Lviv State Oncol. Reg. Treatment and Diagnostic Center | |
| Lviv, Ukraine, 79031 | |
| United Kingdom | |
| Sarah Cannon Research UK | |
| London, Greater London, United Kingdom, W1G 6AD | |
| Barts and the London NHS Trust | |
| London, Greater London, United Kingdom, EC1A 7BE | |
| The Christie NHS Foundation Trust | |
| Manchester, Greater Manchester, United Kingdom, M20 4BX | |
| Study Director: | Melissa Versola, RN | Innovation Quintiles |
More Information
No publications provided
| Responsible Party: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT01355302 History of Changes |
| Other Study ID Numbers: | E7050-703, 2011-000774-58 |
| Study First Received: | May 16, 2011 |
| Last Updated: | March 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Eisai Inc.:
|
Cancer Solid Tumors Gastric Phase I Phase II |
Additional relevant MeSH terms:
|
Stomach Neoplasms 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 21, 2013