An Open-Label Study of E7974 Administered on Days 1, 8, and 15 of a 28-Day Cycle and Days 1 and 8 of a 21-Day Cycle in Patients With Solid Malignancies

NCT00121732 | Completed Phase 1

• 1 other identifier: E7974-A001-101
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine the maximum tolerated dose (MTD) of E7974 administered as an intravenous bolus dose on Days 1, 8, and 15 of a 28-day cycle (Arm A) or on Days 1 and 8 of a 21-day cycle (Arm B) to patients with solid tumors that have progressed following effective therapy or for which no effective therapy exists.

Conditions

Solid Tumor Malignancies, Cancer

Outcome Measures

Primary Outcomes (1)

• Determine the maximum tolerated dose of E7974 in patients with solid malignancies.

  Duration of each cycle will be 28 or 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)

• 1) Assess E7974 for safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD); 2) Evaluate the correlation of AUC with clinical toxicity and efficacy in both arms.

  Duration of each cycle will be 28 or 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 (2)

A

EXPERIMENTAL

Drug: E7974

B

EXPERIMENTAL

Drug: E7974

Interventions

E7974 DRUG

Maximum tolerated dose = 0.15 mg/m\^2 administered on Days 1, 8, 15 of 28-day cycle.

A

Eligibility Criteria

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

You may not qualify if:

• Patients must have a pathologically diagnosed, histologically or cytologically confirmed solid tumor that has progressed following effective therapy or for which no effective therapy exists (including surgery or radiation therapy).
• Patients must be \>= 18 years of age.
• Patients must have an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.
• Patients must have a life expectancy of \>= 3 months.
• Patients must have adequate renal function as evidenced by serum creatinine \<= 1.5 mg/dL or creatinine clearance \>= 40 mL/minute (min).
• Patients must 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.
• Patients must have adequate liver function as evidenced by bilirubin \<= 1.5 mg/dL and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<= 3 times the upper limits of normal (ULN), unless related to liver involvement by tumor, in which case \<= 5.0 times ULN.
• Patients must be willing and able to sign written informed consent and be able to comply with the study protocol for the duration of the study.
• Patients must be willing and able to undergo blood draw and urine sampling for PK in Cycle 1.
• Patients may have either measurable or non-measurable disease.
• 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 three weeks of E7974 treatment start (6 weeks for a nitrosourea).
• Patients who have not recovered from any chemotherapy-related or other therapy-related toxicity to \<= Grade 1 at study entry (excluding Grade 2 alopecia).
• Patients who have received radiotherapy \<= 3 weeks prior to study enrollment, whose marrow exposure has exceeded 25% and who have not recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia).
• Patients who have had major surgery without full recovery or major surgery within three weeks of E7974 treatment start.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (2)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

CTRC

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

E 7974

Study Officials

• Jenny Zhang, M.D.

  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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2005
• First Posted: July 21, 2005
• Study Start: July 1, 2005
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: July 1, 2015

Record last verified: 2015-06

Locations

US (2)