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NCT Number: NCT00921869

A 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.

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Key information

Conditions

Solid Tumors Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kashiwa-shi, Chiba, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

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.

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)

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

Secondary outcomes

  1. Dose-limiting toxicities.

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

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

    Time frame: Throughout the entire study

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study title

A Phase I Dose-finding Study of E7050 Administered Orally to Patients With Advanced Solid Tumors.

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 16, 2009
Registry last updated
Dec 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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