An Open Label Phase I Dose Escalation Study Of E7080

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00121719
First received: July 15, 2005
Last updated: November 14, 2013
Last verified: November 2013

July 15, 2005
November 14, 2013
July 2005
June 2014   (final data collection date for primary outcome measure)
The maximum tolerated dose as defined by an incidence of dose limiting toxicity of no more than 17% (one in six). [ Time Frame: First four weeks of treatment. ] [ Designated as safety issue: Yes ]
To determine the maximum tolerated dose (MTD) of E7080 given as a single daily dose continuously
Complete list of historical versions of study NCT00121719 on ClinicalTrials.gov Archive Site
  • Tumor assessments should be performed at screening and at appropriate clinical intervals as determined by the investigator. [ Time Frame: At screening, every 2 cycles and where clinically indicated. ] [ Designated as safety issue: No ]
  • The best response to treatment with E7080, as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), will be documented. [ Time Frame: Every 2 cycles. ] [ Designated as safety issue: No ]
  • Blood samples taken to determine the pharmacokinetic profile of E7080. [ Time Frame: Blood samples taken from patient on Days 1, 8, 15 and 22 of Cycle 1 and on Day 1 of all other cycles. ] [ Designated as safety issue: No ]
  • Blood samples taken to identify pharmacodynamic biomarkers of E7080. [ Time Frame: Blood samples taken from patient on Days 1, 15 and 22 of Cycle 1 and on Day 1 of all other cycles. ] [ Designated as safety issue: No ]
  • Adverse Events (AEs) recorded to explore the safety and tolerability of E7080. [ Time Frame: All AEs are recorded in case report forms on an ongoing basis throughout the study and constantly monitored and assessed. ] [ Designated as safety issue: Yes ]
  • - To identify the dose limiting toxicities (DLT) of E7080
  • - To explore the safety and tolerability of E7080
  • - To determine the pharmacokinetic profile of E7080
  • - To explore the anti-tumor efficacy of E7080
Not Provided
Not Provided
 
An Open Label Phase I Dose Escalation Study Of E7080
An Open Label Phase I Dose Escalation Study Of E7080

The purpose of this study is to determine the maximum tolerated dose (MTD) of E7080 in patients with solid tumors or lymphomas.

This is an open-label, non-randomized, dose escalation study. Patients will be treated with E7080 once daily. Each four-week treatment period will be considered to be one treatment cycle. The selection of subsequent dose levels will be performed according to an accelerated design: Although initially 3 patients per dose level will be entered, the next dose level can be opened for patient accrual after only the first patient in the previous cohort completes Cycle 1 with no drug-related toxicity >grade 1 (except alopecia, lymphopenia and anemia).

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumor or Lymphoma
Drug: E7080
E7080 tablets taken orally, once daily.
Experimental: 1
Intervention: Drug: E7080
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
82
September 2014
June 2014   (final data collection date for primary outcome measure)

INCLUSION CRITERIA:

Patients must meet all of the inclusion criteria outlined below in order to be eligible to participate in the study:

  1. Patients with histologically and/or cytologically confirmed solid tumor or lymphoma who are resistant/refractory to approved therapies or for whom no appropriate therapies are available.
  2. All previous treatment (including surgery and radiotherapy) must have been completed at least four weeks prior to study entry and any acute toxicities must have resolved.
  3. Aged >= 18 years.
  4. Karnofsky performance status >= 70%.
  5. Written informed consent to participate in the study.

EXCLUSION CRITERIA:

Patients with the following characteristics will not be eligible for the study:

  1. Brain tumors or brain or leptomeningeal metastases.
  2. Any of the following laboratory parameters:

    1. hemoglobin < 9 g/dl (5.6 mmol/L)
    2. neutrophils <1.5 x 10^9/L
    3. platelets <100 x 10^9/L
    4. serum bilirubin >25 µmol/l (1.5 mg/dl)
    5. other liver parameters >3 x the upper limit of normal (ULN)
    6. serum creatinine >1.5 x ULN or creatinine clearance < 60 ml/minute
  3. Uncontrolled infections.
  4. Clinically significant cardiac impairment or unstable ischemic heart disease including a myocardial infarction within six months of study start.
  5. Any treatment with investigational drugs within 30 days before the start of the study.
  6. Pregnancy or lactation (all women of childbearing potential must have a negative pregnancy test before inclusion in the study; post-menopausal women must be amenorrheic for at least 12 months). Female patients of childbearing potential must use adequate contraceptive protection, defined as two forms of contraception, one of which must be a barrier method.
  7. Fertile males not willing to use contraception or whose female partners are not using adequate contraceptive protection.
  8. History of alcoholism, drug addiction, or any psychiatric or psychological condition which, in the opinion of the investigator, would impair study compliance.
  9. Legal incapacity.
  10. Centrally located or squamous cell carcinoma of the lung.
  11. Proteinuria > 1+ on bedside testing.
  12. History of gastrointestinal malabsorption.
  13. Surgery involving gastro- and/or intestinal anastomosis within four weeks of study start.
  14. Patients with bleeding or thrombotic disorders.
  15. Patients using therapeutic dosages of anticoagulants.
  16. Poorly controlled hypertension (defined as a change in hypertensive therapy within three months of study start) or patients diagnosed with hypertension (defined as a repeat blood pressure measurement of 160/90 mmHg or higher) at screening.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   United Kingdom
 
NCT00121719
E7080-E044-101
Not Provided
Eisai Inc.
Eisai Inc.
Not Provided
Study Director: Jantien Wanders, M.D. Eisai Limited
Eisai Inc.
November 2013

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