Trial Outcomes & Findings for Endocrine Therapy + OSI-906 With or Without Erlotinib for Hormone-Sensitive Metastatic Breast Cancer (NCT NCT01205685)
NCT ID: NCT01205685
Last Updated: 2012-09-11
Results Overview
Time to progression measured in months from study entry to date of disease progression
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
From study entry to 6 months
Results posted on
2012-09-11
Participant Flow
This study was conducted from May 2010 and closed early one year later, May 2011.
12 patients consented, one of which was determined to be ineligible.
Participant milestones
| Measure |
OSI-906 + Erlotinib + Letrozole + Goserelin
* OSI-906 in a pill form, by mouth, twice a day (12 hours a part)
* Erlotinib in a pill form, by mouth, once a day
* Letrozole in a pill form, by mouth, once a day
* Goserelin, by injection once per month for women who are pre-menopausal
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
OSI-906 + Erlotinib + Letrozole + Goserelin
* OSI-906 in a pill form, by mouth, twice a day (12 hours a part)
* Erlotinib in a pill form, by mouth, once a day
* Letrozole in a pill form, by mouth, once a day
* Goserelin, by injection once per month for women who are pre-menopausal
|
|---|---|
|
Overall Study
Disease Progression
|
10
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Endocrine Therapy + OSI-906 With or Without Erlotinib for Hormone-Sensitive Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
OSI-906 + Erlotinib + Letrozole + Goserelin
n=11 Participants
* OSI-906 in a pill form, by mouth, twice a day (12 hours a part)
* Erlotinib in a pill form, by mouth, once a day
* Letrozole in a pill form, by mouth, once a day
* Goserelin, by injection once per month for women who are pre-menopausal
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age Continuous
|
59 years
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From study entry to 6 monthsPopulation: Patients who received treatment and who were available for determination of disease progression. One patient withdrew after beginning of treatment and was not available for determination of the duration of disease progression.
Time to progression measured in months from study entry to date of disease progression
Outcome measures
| Measure |
OSI-906 + Erlotinib + Letrozole + Goserelin
n=10 Participants
* OSI-906 in a pill form, by mouth, twice a day (12 hours a part)
* Erlotinib in a pill form, by mouth, once a day
* Letrozole in a pill form, by mouth, once a day
* Goserelin, by injection once per month for women who are pre-menopausal
|
|---|---|
|
Anti-tumor Activity of OSI-906
|
2 months
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: Every 4 weeks up to 24 weeksPopulation: Patients who received treatment and experienced an adverse event.
According to National Cancer Institute Common Toxicity Criteria for Adverse Events with 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening/disabling, and 5 = death.
Outcome measures
| Measure |
OSI-906 + Erlotinib + Letrozole + Goserelin
n=11 Participants
* OSI-906 in a pill form, by mouth, twice a day (12 hours a part)
* Erlotinib in a pill form, by mouth, once a day
* Letrozole in a pill form, by mouth, once a day
* Goserelin, by injection once per month for women who are pre-menopausal
|
|---|---|
|
Safety Profile Based on Number of Patients With Each Worst-grade Toxicity
Patients with worst grade toxicity of 1
|
2 participants
|
|
Safety Profile Based on Number of Patients With Each Worst-grade Toxicity
Patients with worst grade toxicity of 2
|
6 participants
|
|
Safety Profile Based on Number of Patients With Each Worst-grade Toxicity
Patients with worst grade toxicity of 3
|
3 participants
|
|
Safety Profile Based on Number of Patients With Each Worst-grade Toxicity
Patients with worst grade toxicity of 4
|
0 participants
|
|
Safety Profile Based on Number of Patients With Each Worst-grade Toxicity
Patients with worst grade toxicity of 5
|
0 participants
|
SECONDARY outcome
Timeframe: Every 12 weeks to tumor progressionPopulation: Patients who were available for measurement of tumor response.
Per RECIST criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions
Outcome measures
| Measure |
OSI-906 + Erlotinib + Letrozole + Goserelin
n=10 Participants
* OSI-906 in a pill form, by mouth, twice a day (12 hours a part)
* Erlotinib in a pill form, by mouth, once a day
* Letrozole in a pill form, by mouth, once a day
* Goserelin, by injection once per month for women who are pre-menopausal
|
|---|---|
|
Number of Participants With Tumor Response Per RECIST
Complete Response
|
0 participants
|
|
Number of Participants With Tumor Response Per RECIST
Partial Response
|
0 participants
|
|
Number of Participants With Tumor Response Per RECIST
Stable Disease
|
0 participants
|
|
Number of Participants With Tumor Response Per RECIST
Progressive disease
|
10 participants
|
SECONDARY outcome
Timeframe: < or = to 2 weeks before initiation of Phase II study treatment periodPopulation: No correlative studies were performed because the study did not move to the Phase II portion
Biomarkers associated with response to OSI-906 + Erlotinib + Letrozole + Goserelin
Outcome measures
Outcome data not reported
Adverse Events
OSI-906 + Erlotinib + Letrozole + Goserelin
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OSI-906 + Erlotinib + Letrozole + Goserelin
n=11 participants at risk
* OSI-906 in a pill form, by mouth, twice a day (12 hours a part)
* Erlotinib in a pill form, by mouth, once a day
* Letrozole in a pill form, by mouth, once a day
* Goserelin, by injection once per month for women who are pre-menopausal
|
|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
9.1%
1/11 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
18.2%
2/11 • Number of events 2
|
|
General disorders
Fatigue
|
9.1%
1/11 • Number of events 1
|
Other adverse events
| Measure |
OSI-906 + Erlotinib + Letrozole + Goserelin
n=11 participants at risk
* OSI-906 in a pill form, by mouth, twice a day (12 hours a part)
* Erlotinib in a pill form, by mouth, once a day
* Letrozole in a pill form, by mouth, once a day
* Goserelin, by injection once per month for women who are pre-menopausal
|
|---|---|
|
Investigations
alanine aminotransferase increased
|
36.4%
4/11 • Number of events 7
|
|
Investigations
alkaline phosphatase increased
|
27.3%
3/11 • Number of events 4
|
|
Blood and lymphatic system disorders
anemia
|
27.3%
3/11 • Number of events 5
|
|
Metabolism and nutrition disorders
anorexia
|
9.1%
1/11 • Number of events 1
|
|
Investigations
aspartate aminotransferase increased
|
45.5%
5/11 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
back pain
|
9.1%
1/11 • Number of events 1
|
|
Renal and urinary disorders
bladder spasm
|
9.1%
1/11 • Number of events 1
|
|
Investigations
creatinine increased
|
9.1%
1/11 • Number of events 3
|
|
Psychiatric disorders
depression
|
18.2%
2/11 • Number of events 2
|
|
Gastrointestinal disorders
diarrhea
|
36.4%
4/11 • Number of events 4
|
|
Nervous system disorders
dizziness
|
9.1%
1/11 • Number of events 1
|
|
Eye disorders
dry eye
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
dry mouth
|
9.1%
1/11 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
dry skin
|
18.2%
2/11 • Number of events 2
|
|
Cardiac disorders
electrocardiagram QT interval prolonged
|
18.2%
2/11 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
9.1%
1/11 • Number of events 2
|
|
Eye disorders
eye disorders
|
9.1%
1/11 • Number of events 2
|
|
Metabolism and nutrition disorders
hypercalcemia
|
18.2%
2/11 • Number of events 5
|
|
Metabolism and nutrition disorders
hyperglycemia
|
45.5%
5/11 • Number of events 5
|
|
Metabolism and nutrition disorders
hypocalcemia
|
18.2%
2/11 • Number of events 2
|
|
Metabolism and nutrition disorders
hypoglycemia
|
9.1%
1/11 • Number of events 1
|
|
Metabolism and nutrition disorders
hypokalemia
|
36.4%
4/11 • Number of events 5
|
|
Metabolism and nutrition disorders
hyponatremia
|
27.3%
3/11 • Number of events 4
|
|
Psychiatric disorders
insomnia
|
9.1%
1/11 • Number of events 1
|
|
Blood and lymphatic system disorders
leukocytosis
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
mucositis oral
|
18.2%
2/11 • Number of events 2
|
|
Gastrointestinal disorders
nausea
|
18.2%
2/11 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
non-cardiac chest pain
|
9.1%
1/11 • Number of events 1
|
|
General disorders
pain
|
9.1%
1/11 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
rash acneiform
|
63.6%
7/11 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
rash macro-papular
|
9.1%
1/11 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
skin and subcutaneous tissue disorders Other
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
9.1%
1/11 • Number of events 1
|
|
Renal and urinary disorders
urinary incontinence
|
9.1%
1/11 • Number of events 1
|
|
General disorders
flu-like symptoms
|
9.1%
1/11 • Number of events 1
|
|
General disorders
fatigue
|
18.2%
2/11 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
pruritis
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
gastrointestinal disorders Other
|
9.1%
1/11 • Number of events 1
|
|
General disorders
general disorders and administrative site disorders-other
|
9.1%
1/11 • Number of events 2
|
|
Endocrine disorders
hypothyroidism
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
pain-bone
|
9.1%
1/11 • Number of events 1
|
|
Investigations
neutrophil count decreased
|
9.1%
1/11 • Number of events 1
|
|
Investigations
white blood cells decreased
|
9.1%
1/11 • Number of events 1
|
|
Renal and urinary disorders
acute kidney injury
|
9.1%
1/11 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place