Lonafarnib in Metastatic Breast Cancer

NCT00773474 | Terminated Phase 2 Results DMC

• 1 other identifier: HOG BRE07-126
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 6

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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  To determine progression-free survival of lonafarnib in patients with metastatic breast cancer.

  18 months

Secondary Outcomes (3)

• Overall Response Rate

  18 months

• Toxicity Profile of Lonafarib

  18 months

• Clinical Benefit Response Rate (Complete Response (CR)+Partial Response(PR)+Stable Disease(SD) > 180 Day Duration).

  18 months

Study Arms (1)

Lonafarnib

EXPERIMENTAL

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.

Drug: Lonafarnib

Interventions

Lonafarnib 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.

Lonafarnib

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• George Sledge: lead
• Schering-Plough: collaborator
• Hoosier Cancer Research Network: collaborator

Study Sites (6)

Medical & Surgical Specialists, LLC

Galesburg, Illinois, 61401, United States

Location

Cancer Care Center of Southern Indiana

Bloomington, Indiana, 47403, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Arnett Cancer Care

Lafayette, Indiana, 47904, United States

Location

Horizon Oncology Center

Lafayette, Indiana, 47905, United States

Location

Ireland Cancer Center - University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Related Links

• Hoosier Oncology Group Homepage

MeSH Terms

Conditions

Breast Neoplasms

Interventions

lonafarnib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Principal Investigator
• Organization: Hoosier Cancer Research Network, Inc.

jsmith@hoosiercancer.org

317-921-2050

Study Officials

• George Sledge, M.D.

  Hoosier Cancer Research Network

  PRINCIPAL INVESTIGATOR

• Brian Leland-Jones, M.D.

  Hoosier Cancer Research Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: October 14, 2008
• First Posted: October 16, 2008
• Study Start: October 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 18, 2016
• Results First Posted: February 18, 2016

Record last verified: 2016-01

Locations

US (6)