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
  Purpose

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


Condition Intervention Phase
Solid Tumor or Lymphoma
Drug: E7080
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Phase I Dose Escalation Study Of E7080

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 82
Study Start Date: July 2005
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: E7080
E7080 tablets taken orally, once daily.

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121719

Locations
Netherlands
Amsterdam, Netherlands
United Kingdom
Glasgow, United Kingdom
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Jantien Wanders, M.D. Eisai Limited
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00121719     History of Changes
Other Study ID Numbers: E7080-E044-101
Study First Received: July 15, 2005
Last Updated: November 14, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Eisai Inc.:
Resistant and refractory solid tumors
lymphomas
hodgkins disease
non-hodgkins lymphoma
neoplasms

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014