A Phase I Open Label Study of E7974 Administered on a Day 1 of 21-Day Cycle In Patients With Advanced Solid Tumors

NCT00165802 | Completed Phase 1

• 1 other identifier: E7974-A001-103
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine the maximum tolerated dose (MTD) of E7974 after bolus IV administration, on Day 1 of a 21-day cycle, to patients with advanced solid tumors that have progressed following effective therapy or for which no effective therapy exists.

Conditions

Cancer, Malignant Tumors

Keywords

Cancer; malignant tumors

Outcome Measures

Primary Outcomes (1)

• Determine the maximum tolerated dose of E7974 in patients with Advanced Solid Tumors.

  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.

Secondary Outcomes (1)

• Assess E7974 for safety, pharmacokinetics (PK) and pharmacodynamics (PD) which will correlate AUC with clinical toxicity and efficacy.

  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.

Study Arms (1)

1

EXPERIMENTAL

Drug: E7974

Interventions

E7974 DRUG

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.

1

Eligibility Criteria

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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (2)

Sylvester Comprehensive Cancer Center - University of Miami

Miami, Florida, 33136, United States

Location

Cancer Institute Of New Jersey

New Brunswick, New Jersey, 08903-2681, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

E 7974

Study Officials

• Jenny Zhang

  Eisai Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: May 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: January 1, 2009
• Last Updated: May 22, 2013

Record last verified: 2009-08

Locations

US (2)