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

June 15, 2009
April 4, 2012
October 2009
June 2011   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00921869 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
A Study of E7050 Administered Orally to Patients With Advanced Solid Tumors
A Phase I Dose-finding Study of E7050 Administered Orally to Patients With Advanced Solid Tumors.

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumors
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.
Experimental: 1
Intervention: Drug: E7050
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
20 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00921869
E7050-J081-102
Not Provided
Eisai Inc. ( Eisai Co., Ltd. )
Eisai Co., Ltd.
Not Provided
Study Director: Takashi Sawada Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd.
Eisai Inc.
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP