Trial Outcomes & Findings for Fresolimumab and Radiotherapy in Metastatic Breast Cancer (NCT NCT01401062)
NCT ID: NCT01401062
Last Updated: 2019-03-05
Results Overview
Defined as the percentage of patients who have responses (complete or partial) outside the irradiated lesions. The abscopal response is assessed at 15 weeks, and confirmed minimum 4 weeks later. The abscopal response is evaluated based on immune-related response criteria (irRC) (Wolchok et al, 2009).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
up to 20 weeks
Results posted on
2019-03-05
Participant Flow
Participant milestones
| Measure |
Arm 1 (Fresolimumab 1 mg/kg)
Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 \& 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).
Fresolimumab
Radiation Therapy
|
Arm 2 (Fresolimumab 10 mg/kg)
Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 \& 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).
Fresolimumab
Radiation Therapy
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
|
Overall Study
COMPLETED
|
0
|
4
|
|
Overall Study
NOT COMPLETED
|
11
|
8
|
Reasons for withdrawal
| Measure |
Arm 1 (Fresolimumab 1 mg/kg)
Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 \& 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).
Fresolimumab
Radiation Therapy
|
Arm 2 (Fresolimumab 10 mg/kg)
Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 \& 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).
Fresolimumab
Radiation Therapy
|
|---|---|---|
|
Overall Study
Death
|
9
|
7
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Fresolimumab and Radiotherapy in Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm 1 (Fresolimumab 1 mg/kg)
n=11 Participants
Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 \& 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).
Fresolimumab
Radiation Therapy
|
Arm 2 (Fresolimumab 10 mg/kg)
n=12 Participants
Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 \& 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).
Fresolimumab
Radiation Therapy
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, not of Hispanic-American Origin
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, not of Hispanic-American origin
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/Unknown
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 20 weeksDefined as the percentage of patients who have responses (complete or partial) outside the irradiated lesions. The abscopal response is assessed at 15 weeks, and confirmed minimum 4 weeks later. The abscopal response is evaluated based on immune-related response criteria (irRC) (Wolchok et al, 2009).
Outcome measures
| Measure |
Arm 1 (Fresolimumab 1 mg/kg)
n=11 Participants
Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 \& 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).
Fresolimumab
Radiation Therapy
|
Arm 2 (Fresolimumab 10 mg/kg)
n=12 Participants
Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 \& 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).
Fresolimumab
Radiation Therapy
|
|---|---|---|
|
Abscopal Response Rate
|
11 Participants
|
12 Participants
|
Adverse Events
Arm 1 (Fresolimumab 1 mg/kg)
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Arm 2 (Fresolimumab 10 mg/kg)
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1 (Fresolimumab 1 mg/kg)
n=11 participants at risk
Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 \& 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).
Fresolimumab
Radiation Therapy
|
Arm 2 (Fresolimumab 10 mg/kg)
n=12 participants at risk
Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 \& 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).
Fresolimumab
Radiation Therapy
|
|---|---|---|
|
Cardiac disorders
atrial fibrillation
|
18.2%
2/11
|
0.00%
0/12
|
|
Endocrine disorders
Hypercalcemia
|
9.1%
1/11
|
8.3%
1/12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease progression
|
18.2%
2/11
|
16.7%
2/12
|
|
Immune system disorders
Dyspnea
|
0.00%
0/11
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/11
|
8.3%
1/12
|
|
Nervous system disorders
Cord compression
|
9.1%
1/11
|
0.00%
0/12
|
Other adverse events
| Measure |
Arm 1 (Fresolimumab 1 mg/kg)
n=11 participants at risk
Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 \& 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).
Fresolimumab
Radiation Therapy
|
Arm 2 (Fresolimumab 10 mg/kg)
n=12 participants at risk
Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 \& 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).
Fresolimumab
Radiation Therapy
|
|---|---|---|
|
Metabolism and nutrition disorders
hypercalcemia
|
9.1%
1/11
|
8.3%
1/12
|
|
Investigations
Aspartate Aminotransferase Increased
|
27.3%
3/11
|
0.00%
0/12
|
|
Investigations
Alkaline Phosphate Increased
|
18.2%
2/11
|
0.00%
0/12
|
|
Musculoskeletal and connective tissue disorders
Bilaterial Effusion
|
9.1%
1/11
|
0.00%
0/12
|
|
Nervous system disorders
Cord compression
|
9.1%
1/11
|
0.00%
0/12
|
|
Nervous system disorders
Neuropathy
|
9.1%
1/11
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Spinal Edema
|
9.1%
1/11
|
0.00%
0/12
|
|
Investigations
alanine aminotransferase
|
9.1%
1/11
|
0.00%
0/12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease Progression
|
18.2%
2/11
|
16.7%
2/12
|
|
General disorders
Fatigue
|
27.3%
3/11
|
16.7%
2/12
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
18.2%
2/11
|
0.00%
0/12
|
|
Investigations
INR
|
9.1%
1/11
|
0.00%
0/12
|
|
Nervous system disorders
Neuropathy- Lower Extremities
|
9.1%
1/11
|
0.00%
0/12
|
|
Blood and lymphatic system disorders
Anemia
|
9.1%
1/11
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Lower Sacral Pain
|
9.1%
1/11
|
0.00%
0/12
|
|
Gastrointestinal disorders
Abdominal Pain- Severe
|
9.1%
1/11
|
0.00%
0/12
|
|
Reproductive system and breast disorders
Pain (under R breast)
|
9.1%
1/11
|
0.00%
0/12
|
|
Investigations
Elevated Bilirubin
|
9.1%
1/11
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
9.1%
1/11
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
1/11
|
0.00%
0/12
|
|
Investigations
Elevated Amylase
|
9.1%
1/11
|
0.00%
0/12
|
|
Investigations
Elevated Lipase
|
9.1%
1/11
|
0.00%
0/12
|
|
Nervous system disorders
Hepatic Encephalopathy
|
9.1%
1/11
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.1%
1/11
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
9.1%
1/11
|
0.00%
0/12
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
9.1%
1/11
|
8.3%
1/12
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.1%
1/11
|
0.00%
0/12
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11
|
0.00%
0/12
|
|
Investigations
Oliguria
|
9.1%
1/11
|
0.00%
0/12
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
9.1%
1/11
|
0.00%
0/12
|
|
Investigations
PTT
|
0.00%
0/11
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/11
|
8.3%
1/12
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/11
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/11
|
8.3%
1/12
|
|
Investigations
Elevated AST
|
0.00%
0/11
|
8.3%
1/12
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/11
|
8.3%
1/12
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/11
|
8.3%
1/12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place