Lonafarnib in Metastatic Breast Cancer

This study has been terminated.
(funding terminated)
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Hoosier Cancer Research Network
ClinicalTrials.gov Identifier:
NCT00773474
First received: October 14, 2008
Last updated: April 29, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Metastatic Breast Cancer
Drug: Lonafarnib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Lonafarnib in Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Hoosier Cancer Research Network:

Primary Outcome Measures:
  • To determine progression-free survival of lonafarnib in patients with metastatic breast cancer. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the clinical benefit response rate (CR+PR+SD > 180 day duration). [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • To determine overall response rate. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • To determine the toxicity profile of lonafarnib in this patient population. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Enrollment: 27
Study Start Date: October 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lonafarnib Drug: 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.

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773474

Locations
United States, Illinois
Medical & Surgical Specialists, LLC
Galesburg, Illinois, United States, 61401
United States, Indiana
Cancer Care Center of Southern Indiana
Bloomington, Indiana, United States, 47403
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Arnett Cancer Care
Lafayette, Indiana, United States, 47904
Horizon Oncology Center
Lafayette, Indiana, United States, 47905
United States, Ohio
Ireland Cancer Center - University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Hoosier Cancer Research Network
Schering-Plough
Investigators
Principal Investigator: George Sledge, M.D. Hoosier Cancer Research Network
Principal Investigator: Brian Leland-Jones, M.D. Hoosier Cancer Research Network
  More Information

Additional Information:
No publications provided

Responsible Party: George Sledge, M.D., Hoosier Oncology Group
ClinicalTrials.gov Identifier: NCT00773474     History of Changes
Other Study ID Numbers: HOG BRE07-126
Study First Received: October 14, 2008
Last Updated: April 29, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014