Metastatic Breast CancerPhase 2NCT00773474
Lonafarnib in Metastatic Breast Cancer
A Phase 2 study testing Lonafarnib in people with Metastatic Breast Cancer, run by George Sledge at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Lonafarnib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2008to Nov 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Cancer Care Center of Southern Indiana
Bloomington, Indiana, 47403
Ireland Cancer Center - University Hospitals of Cleveland
Cleveland, Ohio, 44106
Medical & Surgical Specialists, LLC
Galesburg, Illinois, 61401
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Arnett Cancer Care
Lafayette, Indiana, 47904
Horizon Oncology Center
Lafayette, Indiana, 47905
About this study
Official title: 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.
Read the 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
- Being tested
- Lonafarnib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LonafarnibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Lonafarnib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
To determine progression-free survival of lonafarnib in patients with metastatic breast cancer.
Measured: 18 months
Secondary outcomes (3)
Overall Response Rate
To determine overall response rate.
Measured: 18 months
Toxicity Profile of Lonafarib
To determine the toxicity profile of lonafarnib in this patient population.
Measured: 18 months
Clinical Benefit Response Rate (Complete Response (CR)+Partial Response(PR)+Stable Disease(SD) > 180 Day Duration).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: funding terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Sledge
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough, Hoosier Cancer Research Network
- Responsible party
- Sponsor-investigator, George Sledge, Hoosier Cancer Research Network
- Investigators
- George Sledge, M.D., Principal investigator, Hoosier Cancer Research NetworkBrian Leland-Jones, M.D., Principal investigator, Hoosier Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00773474
- Sponsor's protocol ID
- HOG BRE07-126
- Status last verified
- Jan 2016
- First submitted
- 14 Oct 2008
- Last updated
- 18 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Lonafarnib in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00773474
- Acronym / sponsor ID
- HOG BRE07-126
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: funding terminated
- Enrolment
- 29 participants (actual)
- Lead sponsor
- George SledgeUniversity, hospital or other
- Collaborators
- Schering-Plough, Hoosier Cancer Research Network
- Study start
- Oct 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 16 Oct 2008 (estimated)
- Results
- Posted 18 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lonafarnib | Experimental | Drug: LonafarnibAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LonafarnibAll 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 |
Primary outcome
Progression Free Survival
Time frame: 18 months
To determine progression-free survival of lonafarnib in patients with metastatic breast cancer.
3 secondary outcomes
Overall Response Rate
Time frame: 18 months
Toxicity Profile of Lonafarib
Time frame: 18 months
Clinical Benefit Response Rate (Complete Response (CR)+Partial Response(PR)+Stable Disease(SD) > 180 Day Duration).
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Hoosier Oncology Group HomepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Sledge, M.D. principal investigator
Hoosier Cancer Research Network
Brian Leland-Jones, M.D. principal investigator
Hoosier Cancer Research Network
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lonafarnib in people with Metastatic Breast Cancer, run by George Sledge at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.