Trial Outcomes & Findings for Tipifarnib and Fulvestrant in Hormone Receptor-Positive Metastatic Breast Cancer (NCT NCT00082810)
NCT ID: NCT00082810
Last Updated: 2018-11-01
Results Overview
Number of participants met the definition of Clinical Benefit Rate.Tumor response was assessed every three cycles by CT using RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
COMPLETED
PHASE2
33 participants
Up to 24 weeks
2018-11-01
Participant Flow
A total of 33 patients were enrolled from 3 institutions between March 2004 and August 2006. Two patients were ineligible; one had a performance status of three and elevated liver function tests that exceeded inclusion criteria, whereas the other received prior chemotherapy for metatstatic disease.
Participant milestones
| Measure |
Fulvestrant 250 mg + Tipifarnib 300 mg
Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
31
|
Reasons for withdrawal
| Measure |
Fulvestrant 250 mg + Tipifarnib 300 mg
Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Progressive disease
|
24
|
|
Overall Study
Withdrawal by Subject
|
4
|
Baseline Characteristics
Tipifarnib and Fulvestrant in Hormone Receptor-Positive Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Fulvestrant 250 mg + Tipifarnib 300 mg
n=33 Participants
Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
|
|---|---|
|
Age, Continuous
|
61.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Whites
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksNumber of participants met the definition of Clinical Benefit Rate.Tumor response was assessed every three cycles by CT using RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Outcome measures
| Measure |
Fulvestrant 250 mg + Tipifarnib 300 mg
n=31 Participants
Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
|
|---|---|
|
Clinical Benefit Rate (CBR) (CR Rate, PR Rate, and SD)
Partial response
|
11 participants
|
|
Clinical Benefit Rate (CBR) (CR Rate, PR Rate, and SD)
Stable disease
|
5 participants
|
|
Clinical Benefit Rate (CBR) (CR Rate, PR Rate, and SD)
Complete response
|
0 participants
|
SECONDARY outcome
Timeframe: From randomization until progression of the disease, assessed up to 4 yearsTTP was estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Fulvestrant 250 mg + Tipifarnib 300 mg
n=31 Participants
Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
|
|---|---|
|
Time to Progression (TTP)
|
7.2 months
Interval 2.8 to 9.8
|
SECONDARY outcome
Timeframe: Up to 4 yearsDOR was defined for responders as the time from the onset of first response to disease progression and for non-responders as zero
Outcome measures
| Measure |
Fulvestrant 250 mg + Tipifarnib 300 mg
n=16 Participants
Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
|
|---|---|
|
Duration of Response
|
16 months
Interval 5.2 to 19.4
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: All treated patients who received at least one dose of tipifarnib were included in the safety analysis. A total of 342 cycles of therapy were administered (median 7 cycles/patient range 1-36 cycles)
Number of Participants with serious (grade 3) or life-threatening (grade 4) adverse events
Outcome measures
| Measure |
Fulvestrant 250 mg + Tipifarnib 300 mg
n=33 Participants
Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
|
|---|---|
|
Toxicity as Assessed by NCI CTCAE Version 3.0
|
33 Participants
|
SECONDARY outcome
Timeframe: From randomization until death or censored at the date of last follow-up, assessed up to 4 yearsThe 95% confidence intervals will be used.
Outcome measures
| Measure |
Fulvestrant 250 mg + Tipifarnib 300 mg
n=31 Participants
Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
|
|---|---|
|
Median Overall Survival
|
19.4 months
Interval 16.1 to 27.6
|
Adverse Events
Fulvestrant 250 mg + Tipifarnib 300 mg
Serious adverse events
| Measure |
Fulvestrant 250 mg + Tipifarnib 300 mg
n=33 participants at risk
Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
|
|---|---|
|
Infections and infestations
Infection
|
3.0%
1/33
|
|
Gastrointestinal disorders
Nausea
|
9.1%
3/33
|
|
Gastrointestinal disorders
Vomiting
|
6.1%
2/33
|
|
Gastrointestinal disorders
Diarrhea
|
3.0%
1/33
|
|
Metabolism and nutrition disorders
Anorexia
|
3.0%
1/33
|
|
General disorders
Fatigue
|
3.0%
1/33
|
|
Cardiac disorders
Cardiac Ischemia
|
3.0%
1/33
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.0%
1/33
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.1%
2/33
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.0%
1/33
|
|
Psychiatric disorders
Insomnia
|
3.0%
1/33
|
|
Psychiatric disorders
Anxiety
|
3.0%
1/33
|
|
Psychiatric disorders
Agitation
|
3.0%
1/33
|
|
Nervous system disorders
Ataxia
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.0%
1/33
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.0%
1/33
|
|
Renal and urinary disorders
Creatinine
|
3.0%
1/33
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.0%
1/33
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.1%
4/33
|
|
Blood and lymphatic system disorders
Anemia
|
6.1%
2/33
|
Other adverse events
| Measure |
Fulvestrant 250 mg + Tipifarnib 300 mg
n=33 participants at risk
Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
24.2%
8/33
|
|
Infections and infestations
Infection
|
9.1%
3/33
|
|
Gastrointestinal disorders
Nausea
|
36.4%
12/33
|
|
Gastrointestinal disorders
Vomiting
|
12.1%
4/33
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
11/33
|
|
Metabolism and nutrition disorders
Anorexia
|
18.2%
6/33
|
|
General disorders
Fatigue
|
36.4%
12/33
|
|
General disorders
Fever
|
9.1%
3/33
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
15.2%
5/33
|
|
Psychiatric disorders
Insomnia
|
12.1%
4/33
|
|
Nervous system disorders
Neuropathy
|
21.2%
7/33
|
|
Psychiatric disorders
Anxiety
|
6.1%
2/33
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.1%
4/33
|
|
Renal and urinary disorders
Creatinine
|
6.1%
2/33
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.1%
2/33
|
Additional Information
NYCC Regulatory Coordinator
Montefiore Medical Center - New York
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60