- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00165802
A Phase I Open Label Study of E7974 Administered on a Day 1 of 21-Day Cycle In Patients With Advanced Solid Tumors
A Phase I Open Label Study of E7974 Administered on Day 1 of a 21-Day Cycle In Patients With Advanced Solid Tumors
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Florida
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Miami, Florida, United States, 33136
- Sylvester Comprehensive Cancer Center - University of Miami
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New Jersey
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New Brunswick, New Jersey, United States, 08903-2681
- Cancer Institute of New Jersey
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: At this time, we are only enrolling patients for the MTD cohort that meet all study entry criteria, plus the CRC criterion (Inclusion Criterion #12).Patients who meet all of the inclusion criteria and none of the exclusion criteria will be eligible for entry into the study. Patients must:
- Have a histologically or cytologically confirmed advanced solid tumor that has progressed following effective therapy or for which no effective therapy exists (including surgery or radiation therapy).
- Be >= 18 years of age.
- Have an Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2.
- Have a life expectancy of >= 3 months.
- Have adequate renal function as evidenced by serum creatinine <= 1.5 mg/dL or creatinine clearance >= 40 mL/minute.
- Have adequate bone marrow function as evidenced by absolute neutrophil count >= 1,500/µL, hemoglobin of >= 9 g/dL (may be transfused), and platelet count (not transfused) >= 100,000/µL.
- Have adequate liver function as evidenced by bilirubin <= 1.5 x ULN and alanine transaminase (ALT) and aspartate transaminase (AST) <= 3 times the upper limits of normal (ULN), unless related to liver involvement by tumor, in which case <= 5.0 x ULN.
- Give written informed consent.
- Be willing and able to comply with the study protocol for the duration of the study.
- Be willing to undergo blood draw and urine sampling for PK in Cycle 1.
- Can have either measurable or non-measurable disease.
- If a CRC patient is being treated at the MTD, they must have <= 4 prior regimens in the metastatic setting.
Exclusion Criteria:The presence of one or more of the following criteria will disqualify a patient from enrollment in the study:
- Patients who have received chemotherapy within 3 weeks of E7974 treatment start; (six weeks for nitrosoureas).
- Patients who have not recovered from any chemotherapy-related or other therapy-related toxicity to < Grade 1 at study entry (excluding alopecia Grade 2).
- Patients who have received radiotherapy <= 3 weeks prior to study enrollment, (prior radiation therapy allowed to <25% of the bone marrow), and who have not recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Lesions that have been radiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.
- Patients who have had major surgery without full recovery or major surgery within three weeks of E7974 treatment start.
- Patients with primary brain tumors or metastasis at study entry must have them controlled for > one month by previous treatment, including radiation therapy and /or corticosteroids.
- Women who are pregnant or breastfeeding.
- Women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test.
- Women of childbearing potential unless (1) surgically sterile or (2) physiologically postmenopausal for > 12 months, or (3) using adequate measures (including barrier methods) of contraception.
- Fertile men or their partners who are not willing to use contraception.
- Patients who have a history of positive testing for Human Immunodeficiency Virus (HIV) and/or have active hepatitis B or active hepatitis C at study entry.
- Patients with severe, uncontrolled intercurrent illness or infection.
- Patients with medically uncontrolled cardiovascular illness defined as unstable angina or congestive heart failure (CHF), with > symptomatic Grade II New York Heart Association (NYHA) Classification, or myocardial infarction (MI) within six months prior to study entry.
- Patients who have received organ allografts requiring immunosuppressive therapy.
- Patients who have received investigational drugs including immunotherapy, gene therapy, hormone therapy, biologic therapy, or chemotherapy within the three-week period prior to E7974 treatment start; patients must have recovered from any previous major therapy related toxicity (Grade 3 or 4) to <= Grade 1 at study entry.
- Patients with a current history of peripheral neuropathy > CTC Grade 2 (e.g., diabetic or chemotherapy-induced neuropathy).
- Patients with a history of uncontrolled seizures.
- Patients with other significant diseases or disorders that, in the investigator's opinion, would exclude them from the study.
- Patients with marked screening or baseline prolongation QT/QTc interval (QTc interval > 470 mm) using the Fridericia method as the main method of QTc analysis.
- Patients with allergy or hypersensitivity to hemiasterlin based product or analogue.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
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Maximum Tolerated Dose defined as 0.45 mg/m^2 administered on Day 1 only of a 21-day cycle; the E7974 compound is administered as a bolus infusion; no placebo is given.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine the maximum tolerated dose of E7974 in patients with Advanced Solid Tumors.
Time Frame: Duration of each cycle will be 21 days; patients will attend a follow-up visit 30 days after last study treatment. Follow-up for safety and efficacy will occur 6 months after the last patient is accrued to the study.
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Duration of each cycle will be 21 days; patients will attend a follow-up visit 30 days after last study treatment. Follow-up for safety and efficacy will occur 6 months after the last patient is accrued to the study.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assess E7974 for safety, pharmacokinetics (PK) and pharmacodynamics (PD) which will correlate AUC with clinical toxicity and efficacy.
Time Frame: Duration of each cycle will be 21 days; patients will attend a follow-up visit 30 days after last study treatment. Follow-up for safety and efficacy will occur 6 months after the last patient is accrued to the study.
|
Duration of each cycle will be 21 days; patients will attend a follow-up visit 30 days after last study treatment. Follow-up for safety and efficacy will occur 6 months after the last patient is accrued to the study.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jenny Zhang, Eisai Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E7974-A001-103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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