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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00921869
First Posted: June 16, 2009
Last Update Posted: April 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose-finding Study of E7050 Administered Orally to Patients With Advanced Solid Tumors.

Further study details as provided by Eisai Inc. ( Eisai Co., Ltd. ):

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 ]

Secondary Outcome Measures:
  • Dose-limiting toxicities. [ Time Frame: During the Run-in Phase and the first 5 weeks of treatment ]
  • Incidence and severity of adverse events and their drug relationship. [ Time Frame: Throughout the entire study ]
  • 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 ]
  • 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 ]
  • 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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT00921869     History of Changes
Other Study ID Numbers: E7050-J081-102
First Submitted: June 15, 2009
First Posted: June 16, 2009
Last Update Posted: April 6, 2012
Last Verified: April 2012

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Cancer
Gastrointestinal Cancer