Trial Outcomes & Findings for MM-111 in Combination With Herceptin in Patients With Advanced Her2 Amplified, Heregulin Positive Breast Cancer (NCT NCT01097460)
NCT ID: NCT01097460
Last Updated: 2015-01-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
2 years
Results posted on
2015-01-07
Participant Flow
Participant milestones
| Measure |
MM-111 + Herceptin
MM-111 will be combined with Herceptin
MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MM-111 in Combination With Herceptin in Patients With Advanced Her2 Amplified, Heregulin Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
MM-111 + Herceptin
n=16 Participants
MM-111 will be combined with Herceptin
MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV
|
|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 11.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Patients that received at least one dose
Outcome measures
| Measure |
MM-111 + Herceptin
n=16 Participants
MM-111 will be combined with Herceptin
MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV
|
|---|---|
|
Incidence of Treatment-emergent AE's
|
16 participants
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
Adverse Events
MM-111 + Herceptin
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MM-111 + Herceptin
n=16 participants at risk
MM-111 will be combined with Herceptin
MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV
|
|---|---|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
TRACHEAL OBSTRUCTION
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
6.2%
1/16 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
MM-111 + Herceptin
n=16 participants at risk
MM-111 will be combined with Herceptin
MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
25.0%
4/16 • Number of events 4 • 2 years
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
18.8%
3/16 • Number of events 3 • 2 years
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
12.5%
2/16 • Number of events 2 • 2 years
|
|
Skin and subcutaneous tissue disorders
RASH
|
12.5%
2/16 • Number of events 2 • 2 years
|
|
Skin and subcutaneous tissue disorders
NAIL DISORDER
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
PHOTOSENSITIVITY REACTION
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
ANAEMIA
|
25.0%
4/16 • Number of events 4 • 2 years
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
18.8%
3/16 • Number of events 3 • 2 years
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
COCCYDYNIA
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
MUSCLE TWITCHING
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Nervous system disorders
HEADACHE
|
25.0%
4/16 • Number of events 4 • 2 years
|
|
Nervous system disorders
DIZZINESS
|
12.5%
2/16 • Number of events 2 • 2 years
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
12.5%
2/16 • Number of events 2 • 2 years
|
|
Nervous system disorders
DYSARTHRIA
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Nervous system disorders
DYSGEUSIA
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Nervous system disorders
HYPOAESTHESIA
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Nervous system disorders
MIGRAINE
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Nervous system disorders
RESTLESS LEGS SYNDROME
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Infections and infestations
URINARY TRACT INFECTION
|
12.5%
2/16 • Number of events 2 • 2 years
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Infections and infestations
PNEUMONIA
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Infections and infestations
SINUSITIS
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Infections and infestations
SKIN INFECTION
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Psychiatric disorders
INSOMNIA
|
25.0%
4/16 • Number of events 4 • 2 years
|
|
Psychiatric disorders
ANXIETY
|
18.8%
3/16 • Number of events 3 • 2 years
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Psychiatric disorders
DEPRESSION
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Investigations
ASPARATATE AMINOTRANSFERASE INCREASED
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Investigations
BLOOD UREA INCREASED
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Investigations
CARDIAC MURMUR
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
COMPRESSION FRACTURE
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
TRACHEAL OBSTRUCTION
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Cardiac disorders
TACHYCARDIA
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Eye disorders
PHOTOPHOBIA
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Eye disorders
VISION BLURRED
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Vascular disorders
HOT FLASH
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Ear and labyrinth disorders
EAR PAIN
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
URINARY TRACT PAIN
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Reproductive system and breast disorders
BREAST PAIN
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Surgical and medical procedures
SINUS OPERATION
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
General disorders
OEDEMA PERIPHERAL
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
DIARRHOEA
|
43.8%
7/16 • Number of events 7 • 2 years
|
|
Gastrointestinal disorders
CONSTIPATION
|
18.8%
3/16 • Number of events 3 • 2 years
|
|
Gastrointestinal disorders
VOMITING
|
18.8%
3/16 • Number of events 3 • 2 years
|
|
Gastrointestinal disorders
DYSPEPSIA
|
12.5%
2/16 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
NAUSEA
|
12.5%
2/16 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
DYSPHAGIA
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
General disorders
FATIGUE
|
50.0%
8/16 • Number of events 8 • 2 years
|
|
General disorders
MUCOSAL INFLAMMATION
|
12.5%
2/16 • Number of events 2 • 2 years
|
|
General disorders
OEDEMA
|
12.5%
2/16 • Number of events 2 • 2 years
|
|
General disorders
PAIN
|
12.5%
2/16 • Number of events 2 • 2 years
|
|
General disorders
CHILLS
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
General disorders
LOCALISED OEDEMA
|
6.2%
1/16 • Number of events 1 • 2 years
|
|
Reproductive system and breast disorders
DYSPNOEA
|
37.5%
6/16 • Number of events 6 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
18.8%
3/16 • Number of events 3 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
12.5%
2/16 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
6.2%
1/16 • Number of events 1 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER