Lonafarnib in Metastatic Breast Cancer

NCT ID: NCT00773474

Last Updated: 2016-02-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-11-30

Brief Summary

A published phase 2 study reported that lonafarnib was administered as a single agent via continuous or intermittent oral dosing to 76 women with advanced breast cancer who were previously treated with chemotherapy and/or with endocrine therapy. Objective response rates of approximately 10% were observed. This study will determine the rate of progression-free survival of patients with metastatic breast cancer who receive lonafarnib.

Detailed Description

OUTLINE: This is a multi-center study

Patients will be treated with lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.

1 Cycle = 21 days of lonafarnib (plus the time required to recover from toxicity if encountered).

ECOG Performance Status 0-1

Life Expectancy: Not Specified

Hematopoietic:

• Platelets > 100 K/mm3
• Absolute Neutrophil Count (ANC) > 1.2 K/mm3
• Hemoglobin ≥ 9 g/dl
• Serum potassium ≥ 3.3 mmol/L

Hepatic:

• Aspartate transaminase (AST) ≤ 5.0 x ULN
• Alanine transaminase (ALT) ≤ 5.0 x ULN
• Total bilirubin < 1.5 x ULN

Renal:

• Calculated creatinine clearance (using Cockcroft-Gault formula) > 45 cc/min

Cardiovascular:

• No history of Torsades de Pointes, ventricular tachycardia, ventricular fibrillation or ventricular flutter

Conditions

Metastatic Breast Cancer

Study Design

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

Study Groups

Lonafarnib

All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.

Group Type: EXPERIMENTAL

Lonafarnib

Intervention Type: DRUG

All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.

Interventions

Lonafarnib

All registered patients will be treated with Lonafarnib 200 mg PO BID daily on days 1-21 of every 21-day cycle until progression of disease, unacceptable toxicity, or investigator's discretion.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histological or cytological confirmed adenocarcinoma of the breast with locally advanced or metastatic disease.
• Must be able and willing to enroll in the companion study entitled "Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study: Hoosier Oncology Group COE-03."
• Must have measurable disease per RECIST as evaluated by imaging within 28 days prior to registration for protocol therapy.
• Must be willing to not drink grapefruit juice for the duration of lonafarnib therapy.
• Previously radiated area(s) must not be the only site of disease for study entry.
• Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time of consent until at least 90 days following completion of study treatment.
• Females of childbearing potential must have a negative pregnancy test within 7 days prior to registration for protocol therapy. Subjects are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
• Females must not be breastfeeding.
• Written informed consent and HIPAA authorization for release of personal health information.
• Age > 18 years

Exclusion Criteria

• No history or radiologic evidence of CNS metastases including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement (head CT or MRI must be obtained within 42 days prior to registration for protocol therapy).
• No treatment with any investigational agent within 30 days prior to registration for protocol therapy.
• No history of Torsades de Pointes, ventricular tachycardia, ventricular fibrillation or ventricular flutter.
• No history of syncope.
• No history of seizures.
• No prolonged QTc interval > 450msec on pre-entry electrocardiogram obtained within 28 days prior to registration for protocol therapy.
• No history of hypokalemia that cannot be corrected prior to registration for protocol therapy.
• No radiation within 14 days prior to registration for protocol therapy. Patients must have recovered from the acute toxic effects prior to registration for protocol therapy.
• No prior chemotherapy within 21 days prior to registration for protocol therapy.
• No clinically active serious infections as judged by the treating investigator (CTC v3, > Grade 2) including known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
• Following concomitant medications must be discontinued 7 days prior to registration for protocol therapy and for the duration of lonafarnib therapy: bisphosphonates, including but not limited to etidronate (Didronel), pamidronate (Aredia), alendronate (Fosamax), risedronate (Actonel), zoledronate (Zometa or Reclast), ibandronate (Boniva), ethinylestradiol, gestodene, itraconazole, ketoconazole, cimetidine, erythromycin, carbamazepine, high dose chronic steroids, phenobarbital, phenytoin, rifampin (rifampicin), sulfinpyrazone

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

Sponsors

Schering-Plough

INDUSTRY

Sponsor Role: collaborator

Hoosier Cancer Research Network

OTHER

Sponsor Role: collaborator

George Sledge

OTHER

Sponsor Role: lead

Responsible Party

George Sledge

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

George Sledge, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hoosier Cancer Research Network

Brian Leland-Jones, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hoosier Cancer Research Network

Locations

Medical & Surgical Specialists, LLC

Galesburg, Illinois, United States

Cancer Care Center of Southern Indiana

Bloomington, Indiana, United States

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Arnett Cancer Care

Lafayette, Indiana, United States

Horizon Oncology Center

Lafayette, Indiana, United States

Ireland Cancer Center - University Hospitals of Cleveland

Cleveland, Ohio, United States

Countries

United States

Related Links

http://www.hoosieroncologygroup.org

Hoosier Oncology Group Homepage

http://meetinglibrary.asco.org/content/60283?format=posterImg&poster=1

ASCO Poster

Other Identifiers

HOG BRE07-126

Identifier Type: -

Identifier Source: org_study_id