Eribulin Mesylate in Combination With Intermittent Erlotinib in Patients With Previously Treated, Advanced Non-Small Cell Lung Cancer

NCT ID: NCT01104155

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-22
• Study Completion Date: 2017-01-18

Brief Summary

This is a Phase 2, multicenter, randomized study of two different dose regimens of eribulin mesylate in combination with intermittent erlotinib in patients with previously treated, advanced non-small cell lung cancer.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

eribulin mesylate, 21 day cycle

Group Type: ACTIVE_COMPARATOR

eribulin mesylate + erlotinib

Intervention Type: DRUG

21-day Regimen: Eribulin mesylate given at a dose of 2 mg/m2 as a 2-5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 2-16 of a 21-day cycle.

eribulin mesylate, 28 day cycle

Group Type: ACTIVE_COMPARATOR

eribulin mesylate + erlotinib

Intervention Type: DRUG

28-day Regimen: Eribulin mesylate given at a dose of 1.4 mg/m2 as a 2-5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15-28 of a 28-day cycle.

Interventions

eribulin mesylate + erlotinib

21-day Regimen: Eribulin mesylate given at a dose of 2 mg/m2 as a 2-5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 2-16 of a 21-day cycle.

Intervention Type: DRUG

eribulin mesylate + erlotinib

28-day Regimen: Eribulin mesylate given at a dose of 1.4 mg/m2 as a 2-5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15-28 of a 28-day cycle.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed non-small cell lung cancer (NSCLC)
• At least one prior platinum-based doublet anti-cancer treatment for recurrent or advanced NSCLC
• Disease progression during or after the last anti-cancer therapy
• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
• Serum creatinine less than or equal to 2.0 mg/dL or creatinine clearance 40 mL/min according to Cockcroft and Gault formula:
• Absolute neutrophil count greater than or equal to 1.5 x 10^9/L, hemoglobin greater than or equal to 10 g/dL (can be corrected by growth factor or transfusion), and platelet count greater than or equal to 100 x 10^9/L
• Total bilirubin less than or equal to 1.5 times the upper limit of normal (ULN) and alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 times ULN (in the case of liver metastases less than or equal to 5 times ULN). In case AP is greater than 3 times ULN (in absence of liver metastases) or greater than 5 times ULN (in presence of liver metastases) AND subject also is known to have bone metastases, the liver specific AP must be separated from the total and used to assess the liver function instead of the total AP.
• At least one lesion of greater than or equal to 1.5 cm in longest diameter for non-lymph nodes or greater than or equal to 1.5 cm in shortest diameter for lymph nodes which is serially measurable according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.17

• Males and females, age greater than or equal to 18 years
• Provide written informed consent
• Are willing and able to comply with all aspects of the protocol
• Females of childbearing potential must have a negative serum beta-human chorionic gonadotropin (Beta-hCG) at Visit 1 (Screening) and a negative urine pregnancy test prior to starting study drug (Visit 2). Female subjects of childbearing potential must agree to be abstinent or to use highly effective methods of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, intrauterine device (IUD), or have a vasectomised partner) having starting for at least one menstrual cycle prior to starting study drugs and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
• Male subjects who are not abstinent or have not undergone a successful vasectomy, who are partners of women of childbearing potential must use, or their partners must use a highly effective method of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, IUD) starting for at least one menstrual cycle prior to starting study drugs and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Those with partners using hormonal contraceptives must also be using an additional approved method of contraception (as described previously).

Exclusion Criteria

• Prior therapy with eribulin or an tyrosine kinase inhibitor of the epidermal growth factor receptor
• Subjects with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued steroids for this indication for greater than or equal to 4 weeks before starting study treatment. Symptoms attributed to brain metastases must be stable for greater than or equal to 4 weeks before starting study treatment; radiographic stability should be determined by comparing contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) brain scan performed during screening to a prior scan performed 4 weeks earlier.
• Existing anti-cancer therapy-related toxicities of grade greater than or equal to 2, other than any grade of alopecia or grade less than or equal to 2 neuropathy, which are acceptable
• Current smokers who will not stop smoking one week prior to treatment and during the study
• History of congestive heart failure with New York Heart Association (NYHA) Grade greater than II, unstable angina, myocardial infarction within the past 6 months, serious cardiac arrhythmia
• Electrocardiogram with QTc interval greater than or equal to 500 msec based upon Bazett's formula (QTcB)
• Females who are pregnant (positive Beta-hCG test) or breastfeeding
• Subject with hypersensitivity to eribulin and /or erlotinib or any of the excipients
• Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors
• Subjects who are known to be human immunodeficiency virus (HIV) positive, because the neutropenia caused by the study treatments may make such subjects particularly susceptible to infection
• Subjects with active viral hepatitis (A, B, or C) as demonstrated by positive serology
• Radiotherapy, chemotherapy, biological therapy or investigational agents within 2 weeks prior to start of study treatment
• Meningeal carcinomatosis
• History of drug or alcohol dependency or abuse within approximately the last 2 years
• Medically unfit to receive the study drug or unsuitable for any other reason according to investigator judgment
• Any history of or concomitant medical condition that, in the opinion of the Investigator, would compromise the subject's ability to safely complete the study
• Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bessemer, Alabama, United States

Birmingham, Alabama, United States

Beverly Hills, California, United States

La Jolla, California, United States

Aurora, Colorado, United States

Boulder, Colorado, United States

Colorado Springs, Colorado, United States

Denver, Colorado, United States

Lakewood, Colorado, United States

Littleton, Colorado, United States

Lone Tree, Colorado, United States

Longmont, Colorado, United States

Parker, Colorado, United States

Thornton, Colorado, United States

Washington D.C., District of Columbia, United States

Ocala, Florida, United States

Port Saint Lucie, Florida, United States

Kansas City, Kansas, United States

Overland Park, Kansas, United States

Shawnee Mission, Kansas, United States

Detroit, Michigan, United States

Columbia, Missouri, United States

Jefferson City, Missouri, United States

Kansas City, Missouri, United States

Lee's Summit, Missouri, United States

St Louis, Missouri, United States

Las Vegas, Nevada, United States

Elizabeth City, North Carolina, United States

Portland, Oregon, United States

Tualatin, Oregon, United States

Philadelphia, Pennsylvania, United States

East Providence, Rhode Island, United States

Dallas, Texas, United States

Fort Worth, Texas, United States

Garland, Texas, United States

Plano, Texas, United States

Arlington, Virginia, United States

Chesapeake, Virginia, United States

Fairfax, Virginia, United States

Gainesville, Virginia, United States

Hampton, Virginia, United States

Leesburg, Virginia, United States

Newport News, Virginia, United States

Norfolk, Virginia, United States

Virginia Beach, Virginia, United States

Williamsburg, Virginia, United States

Winchester, Virginia, United States

Woodbridge, Virginia, United States

Spokane, Washington, United States

Vancouver, Washington, United States

Hong Kong, , Hong Kong

Kuantan, Pahang, Malaysia

George Town, , Malaysia

Singapore, , Singapore

Goyang, , South Korea

Gyeonggi-do, , South Korea

Seoul, , South Korea

Taichung, , Taiwan

Tainan City, , Taiwan

Taipei, , Taiwan

Bangkok, , Thailand

Chiang Mai, , Thailand

Lampang, , Thailand

Songkhla, , Thailand

Countries

United States; Hong Kong; Malaysia; Singapore; South Korea; Taiwan; Thailand

References

Mok TS, Geater SL, Iannotti N, Thongprasert S, Spira A, Smith D, Lee V, Lim WT, Reyderman L, Wang B, Gopalakrishna P, Garzon F, Xu L, Reynolds C. Randomized phase II study of two intercalated combinations of eribulin mesylate and erlotinib in patients with previously treated advanced non-small-cell lung cancer. Ann Oncol. 2014 Aug;25(8):1578-84. doi: 10.1093/annonc/mdu174. Epub 2014 May 14.

Reference Type: DERIVED

PMID: 24827127 (View on PubMed)

Other Identifiers

E7389-G000-205

Identifier Type: -

Identifier Source: org_study_id