A Phase 1 Open-Label Study of E7974 Administered on Days 1 and 15 of a 28-Day Cycle in Patients With Solid Malignancies

NCT00130169 | Completed Phase 1

• 1 other identifier: E7974-A001-102
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine the maximum tolerated dose (MTD) of E7974 administered on Days 1 and 15 of a 28-day cycle in subjects with solid malignancies 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 solid malignancies.

  Duration of each cycle will be 28 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, efficacy, pharmacokinetics and pharmacodynamics; evaluate the efficacy of E7974 in patients with metastatic, refractory prostate cancer.

  Duration of each cycle will be 28 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 0.35 mg/m\^2 administered on Days 1 and 15 only of a 28-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:

• Patients must have a pathologically diagnosed, histologically or cytologically confirmed solid malignancy 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, 1 or 2.
• 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 \>= 1,200/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.
• For Prostate Cancer patients only being enrolled at the MTD expansion phase:
• Males with histologically proven adenocarcinoma of the prostate that has progressed (i.e. a minimum of three successive baseline values to document two consecutive rises in Prostate Specific Antigen (PSA) (with the last value 5 ng/mL) taken at least one week apart prior to study entry) despite castration or maintenance of castrate-level testosterone (defined as serum testosterone 50 ng/dL or 1.7 nmol/L), during non-hormonal chemotherapy.
• Patients must have failed at least one previous chemotherapeutic regimen with tubulin binding agents such as docetaxel.
• 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).

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (2)

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

University Hospital Medical Center - SUNY at Stony Brook

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

E 7974

Study Officials

• Naseem Zojwalla, 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: August 12, 2005
• First Posted: August 15, 2005
• Study Start: January 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: July 1, 2015

Record last verified: 2015-06

Locations

US (2)