Lonafarnib in Metastatic Breast Cancer

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

October 14, 2008
April 29, 2011
October 2008
November 2010   (final data collection date for primary outcome measure)
To determine progression-free survival of lonafarnib in patients with metastatic breast cancer. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00773474 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Lonafarnib in Metastatic Breast Cancer
A Phase II Study of Lonafarnib in Patients With Metastatic Breast Cancer

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.

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
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
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.
Experimental: Lonafarnib
Intervention: Drug: Lonafarnib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
27
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00773474
HOG BRE07-126
Yes
George Sledge, M.D., Hoosier Oncology Group
Hoosier Oncology Group
Schering-Plough
Principal Investigator: George Sledge, M.D. Hoosier Oncology Group
Principal Investigator: Brian Leland-Jones, M.D. Hoosier Oncology Group
Hoosier Oncology Group
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP