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

NCT00921869 | Completed Phase 1

• 1 other identifier: E7050-J081-102
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Solid Tumors

Keywords

Cancer; Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

• 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)

  During the Run-in Phase and the first 5 weeks of treatment

Secondary Outcomes (5)

• Dose-limiting toxicities.

  During the Run-in Phase and the first 5 weeks of treatment

• Incidence and severity of adverse events and their drug relationship.

  Throughout the entire study

• PK of blood and urine

  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.

  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.

  Every 4 weeks for complete and partial response; by 7th week for stable disease

Study Arms (1)

1

EXPERIMENTAL

Drug: E7050

Interventions

E7050 DRUG

The starting dose of E7050 will be 50 mg given orally, twice-daily, in patients with advanced tumors that have progressed following effective therapy.

1

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with a histological or cytological diagnosis of solid tumors or gastric cancer.
• Subjects who have progressed after treatment with approved therapies or for whom there are no standard effective therapies available.
• Subjects with adequate organ function.
• 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.
• Subjects with Performance Status (PS) 0-1 established by Eastern Cooperative Oncology Group (ECOG).

You may not qualify if:

• Subjects who have brain metastases with clinical symptoms or which requires treatment.
• Subjects with the serious complications or disease history.
• Subjects who cannot take oral medication.
• Subjects who need continuous use of drugs or foods that strongly inhibit or induce CYP3A4/5 or CYP2D6 during the study period.
• Female subjects who are pregnant or breast-feeding.

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Kashiwa-shi, Chiba, Japan

Location

MeSH Terms

Conditions

Neoplasms; Gastrointestinal Neoplasms

Interventions

N-(2-fluoro-4-((2-(4-(4-methylpiperazin-1-yl)piperidin-1-yl)carbonylaminopyridin-4-yl)oxy)phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Takashi Sawada

  Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2009
• First Posted: June 16, 2009
• Study Start: October 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 26, 2017

Record last verified: 2017-12

Locations

JP (1)