Phase II Study Of E7389, Halichondrin B Analogue, In Patients With Advanced Non-Small Cell Lung Cancer, NSCLC, Who Progressed During Or After Platinum-Based Doublet Chemotherapy

NCT00100932 | Completed Phase 2 Results

• 1 other identifier: E7389-A001-202
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 13

Brief Summary

This is a study of E7389 in patients with recurrent and/or metastatic Non-Small-Cell Lung Cancer (NSCLC) who progressed during or after treatment with a platinum agent and another chemotherapy.

Conditions

Non-Small-Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Objective Response Rate (ORR)

  Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).

  From start of treatment until disease progression or recurrence

Secondary Outcomes (3)

• Duration of Response

  From time of CR or PR until recurrence or progressive disease

• Progression Free Survival

  From start of study medication until progressive disease or death

• Overall Survival

  From time of start of study medication until death

Study Arms (2)

1

EXPERIMENTAL

E7389 28 day cycle

Drug: E7389 28 Day Cycle

2

EXPERIMENTAL

E7389 21 day cycle

Drug: E7389 21 Day Cycle

Interventions

E7389 28 Day Cycle DRUG

E7389 1.4 mg/m\^2 IV bolus on Days 1, 8, and 15 of a 28 day cycle.

1

E7389 21 Day Cycle DRUG

E7389 1.4 mg/m\^2 IV bolus on Days 1 and 8 of a 21 day cycle.

2

Eligibility Criteria

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

You may qualify if:

• Patients must have a histologically or cytologically confirmed diagnosis of non-small cell lung cancer with at least one site of measurable disease by the RECIST criteria.
• Patients must have failed prior platinum-containing doublet chemotherapy. Patients who have received single agent chemotherapy with or without a subsequent taxane containing regimen may be enrolled after discussion with Sponsor.
• Patients must be ≥ 18 years of age.
• Patients must have a performance score of 0 or 1 using the ECOG performance scale.
• Patients must have a life expectancy of ≥ 3 months.
• Patients must have adequate renal function as evidenced by a serum creatinine ≤ 2.0 mg/dL or a calculated creatinine clearance ≥ 40 mL/min per the Cockcroft and Gault formula.
• Patients must have adequate hepatic function as evidenced by bilirubin ≤1.5 mg/dL and alkaline phosphatase, AST and ALT ≤ 3 times upper limit of normal, unless there is evidence of liver metastases, in which case the alkaline phosphatase, AST and ALT must be ≤ 5 times upper limit of normal.
• Patients must have adequate bone marrow function as evidenced by absolute neutrophil counts (ANC) ≥ 1.5 X 10\^9/L, hemoglobin ≥ 10.0 g/dL (a hemoglobin \< 10.0 g/dL would be acceptable if it can be corrected by growth factor or transfusion), and platelet count ≥ 100 X 10\^9/L.
• Patients must be willing and able to comply with the protocol guidelines for the duration of the study.
• Patients must be willing and able to complete the Lung Cancer Symptom Scale (LCSS) instrument.
• The biopsy specimen (paraffin block or at least 10 unstained slides) must be available from either the initial diagnosis or any subsequent diagnostic or surgical procedure of patients participating in the pharmacogenomics sub-study only. However, no additional biopsies are obligatory for participation in this study except those required for confirmation of the diagnosis.
• Patients must give written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.

You may not qualify if:

• Patients with pre-existing peripheral neuropathy \> Grade 2
• Patients who require therapeutic doses of warfarin
• Patients who have not recovered from any chemotherapy, radiation or other therapy related toxicity deemed to be clinically significant at study entry
• Patients with active symptomatic brain metastases. Patients with central nervous system (CNS) metastases are considered eligible if they have had adequately treated brain metastases, i.e. have completed treatment (tapered off steroids) at least four weeks before starting treatment with E7389. Patients who have no evidence that the metastases are symptomatic or actively growing (no evidence of midline shift on CT scan or MRI) may be enrolled without initiation of local therapy for the CNS metastases. In this case, a repeat scan must be performed within four weeks of the original scan to ensure that disease progression is not occurring. It is not the intention of this study to treat patients with active brain metastases.
• Patients who have a positive history for HIV, active hepatitis B or active hepatitis C.
• Patients with other significant medical, or psychiatric disorders that, in the opinion of the investigator, will exclude the patient from the study for compliance or safety reasons
• Patients who have received investigational drugs, including immunotherapy, gene therapy, hormone therapy (except megestrol acetate for appetite stimulation), or other biological therapy; conventional chemotherapy or radiation therapy (except for palliation, defined as less than 10% of the bone marrow reserve and less than 20 Gy), within three weeks of E7839 enrollment
• Patients who have received non-cytotoxics (eg, gefitinib, erlotinib) within one week of E7389 enrollment
• Patients who have not recovered from major surgery within three weeks of E7389 enrollment
• Patients with severe/uncontrolled intercurrent illness/infection
• Patients with significant cardiovascular impairment (history of congestive heart failure\>NYHA grade II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia)
• Patients with organ allografts
• Patients with hypersensitivity to halichondrin B and/or halichondrin B-related compounds
• Patients who participated in a prior E7389 clinical trial
• Patients with second malignancy within the past 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma of the skin

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (13)

Unknown Facility

Gilroy, California, United States

Location

Unknown Facility

Ocala, Florida, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Columbia, Missouri, United States

Location

Unknown Facility

Saint Joseph, Missouri, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

McCook, Nebraska, United States

Location

Unknown Facility

Canton, Ohio, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Fort Worth, Texas, United States

Location

Unknown Facility

Fairfax, Virginia, United States

Location

Unknown Facility

Norfolk, Virginia, United States

Location

Unknown Facility

Vancouver, Washington, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

eribulin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Peter Tarassoff
• Organization: Eisai

888-422-4743

Study Officials

• Dale Shuster, Ph.D.

  Eisai Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2005
• First Posted: January 10, 2005
• Study Start: December 1, 2004
• Primary Completion: June 1, 2008
• Last Updated: March 27, 2012
• Results First Posted: January 31, 2012

Record last verified: 2012-03

Locations

US (13)