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A Phase II Study of Lonafarnib in Patients With Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Breast Cancer

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Trial Information

A Phase II Study of Lonafarnib in Patients With Metastatic Breast Cancer


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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

George Sledge, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hoosier Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

HOG BRE07-126

NCT ID:

NCT00773474

Start Date:

October 2008

Completion Date:

November 2010

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms

Name

Location

Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Arnett Cancer CareLafayette, Indiana  47904
Medical & Surgical Specialists, LLCGalesburg, Illinois  61401
Cancer Care Center Of Southern IndianaBloomington, Indiana  47403
Horizon Oncology CenterLafayette, Indiana  47905
Ireland Cancer Center - University Hospitals of ClevelandCleveland, Ohio  44106