Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of E7050 Administered Orally to Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT00921869
First received: June 15, 2009
Last updated: April 4, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to determine the maximum tolerated dose (MTD), safety, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of E7050 when administered orally twice daily to patients with advanced solid tumors.


Condition Intervention Phase
Solid Tumors
Drug: E7050
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Dose-finding Study of E7050 Administered Orally to Patients With Advanced Solid Tumors.

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Determination of the MTD of E7050 given orally twice daily. MTD is the highest dose at which no more than 1 out of 6 patients experiences dose-limiting toxicity (DLT) [ Time Frame: During the Run-in Phase and the first 5 weeks of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Dose-limiting toxicities. [ Time Frame: During the Run-in Phase and the first 5 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Incidence and severity of adverse events and their drug relationship. [ Time Frame: Throughout the entire study ] [ Designated as safety issue: Yes ]
  • PK of blood and urine [ Time Frame: During the Run-in Phase, Cycle 1 (28 days) and Day 15 of Cycle 2 for blood; Day 28 of Cycle 1 for urine ] [ Designated as safety issue: No ]
  • Pharmacodynamic (PD) biomarker analysis of blood and tumor tissue samples. [ Time Frame: During Cycle 1 (28 days) and Day 15 of Cycle 2 for blood; on Day 22 of Cycle 1 for optional tumor biopsies ] [ Designated as safety issue: No ]
  • Best overall tumor response, duration of response and stable disease, assessed by Response Evaluation Criteria in Solid Tumors. [ Time Frame: Every 4 weeks for complete and partial response; by 7th week for stable disease ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: October 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: E7050
The starting dose of E7050 will be 50 mg given orally, twice-daily, in patients with advanced tumors that have progressed following effective therapy.

Detailed Description:

Phase I, open-label, dose-escalation study to determine the maximum tolerated dose (MTD) of E7050 given orally, twice-daily, in patients with advanced tumors that have progressed following effective therapy.

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Subjects with a histological or cytological diagnosis of solid tumors or gastric cancer.
  2. Subjects who have progressed after treatment with approved therapies or for whom there are no standard effective therapies available.
  3. Subjects with adequate organ function.
  4. Patients who have no carryover of effect from prior therapy or no adverse drug reactions (excluding alopecia) that may affect the safety evaluation of the investigational drug.
  5. Subjects with Performance Status (PS) 0-1 established by Eastern Cooperative Oncology Group (ECOG).

Exclusion criteria:

  1. Subjects who have brain metastases with clinical symptoms or which requires treatment.
  2. Subjects with the serious complications or disease history.
  3. Subjects who cannot take oral medication.
  4. Subjects who need continuous use of drugs or foods that strongly inhibit or induce CYP3A4/5 or CYP2D6 during the study period.
  5. Female subjects who are pregnant or breast-feeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921869

Locations
Japan
National Cancer Center
Kashiwa-shi, Chiba, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Takashi Sawada Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd.
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT00921869     History of Changes
Other Study ID Numbers: E7050-J081-102
Study First Received: June 15, 2009
Last Updated: April 4, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
Cancer
Gastrointestinal Cancer

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014