Trial Outcomes & Findings for A Study of MM-111 and Paclitaxel With Trastuzumab in Patients HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach (NCT NCT01774851)
NCT ID: NCT01774851
Last Updated: 2017-06-22
Results Overview
Target and non-target lesion antitumor response and disease progression during treatment with each dosing regimen will be evaluated using the international criteria proposed by the RECIST v1.1. Disease status will be assessed every 8 weeks from the date of the first dose of any drug in a regimen.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
30 months
Results posted on
2017-06-22
Participant Flow
Participant milestones
| Measure |
Control Group
Paclitaxel + Trastuzumab
|
Experimental Group
MM-111 + trastuzumab + paclitaxel
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
|
Overall Study
COMPLETED
|
42
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of MM-111 and Paclitaxel With Trastuzumab in Patients HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach
Baseline characteristics by cohort
| Measure |
Control Group
n=42 Participants
Trastuzumab + paclitaxel
|
Experimental Group
n=42 Participants
MM-111 + trastuzumab + paclitaxel
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.5 years
n=93 Participants
|
63.5 years
n=4 Participants
|
63 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
77 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
82 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
59 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=93 Participants
|
13 participants
n=4 Participants
|
26 participants
n=27 Participants
|
|
Region of Enrollment
Denmark
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Region of Enrollment
France
|
1 participants
n=93 Participants
|
0 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Region of Enrollment
Korea, Republic of
|
11 participants
n=93 Participants
|
10 participants
n=4 Participants
|
21 participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
9 participants
n=93 Participants
|
8 participants
n=4 Participants
|
17 participants
n=27 Participants
|
|
Region of Enrollment
Taiwan
|
2 participants
n=93 Participants
|
2 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=93 Participants
|
8 participants
n=4 Participants
|
14 participants
n=27 Participants
|
|
Subject of child bearing potential
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Height
|
172 cm
n=93 Participants
|
170.19 cm
n=4 Participants
|
171 cm
n=27 Participants
|
|
Weight
|
73.97 kg
n=93 Participants
|
68 kg
n=4 Participants
|
72.51 kg
n=27 Participants
|
PRIMARY outcome
Timeframe: 30 monthsTarget and non-target lesion antitumor response and disease progression during treatment with each dosing regimen will be evaluated using the international criteria proposed by the RECIST v1.1. Disease status will be assessed every 8 weeks from the date of the first dose of any drug in a regimen.
Outcome measures
| Measure |
Control Group
n=42 Participants
trastuzumab + paclitaxel
|
Experimental Group
n=42 Participants
MM-111 + trastuzumab + paclitaxel
|
|---|---|---|
|
Progression Free Survival (PFS)
|
23.3 weeks
Interval 12.1 to 27.0
|
9.6 weeks
Interval 8.0 to 15.7
|
Adverse Events
Control Group
Serious events: 16 serious events
Other events: 26 other events
Deaths: 18 deaths
Experimental Group
Serious events: 19 serious events
Other events: 39 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Control Group
n=42 participants at risk
trastuzumab + paclitaxel
|
Experimental Group
n=42 participants at risk
MM-111 + trastuzumab + paclitaxel
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.8%
2/42 • Number of events 2
|
0.00%
0/42
|
|
Gastrointestinal disorders
Ascites
|
2.4%
1/42 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Upper GI haemorrhage
|
4.8%
2/42 • Number of events 2
|
0.00%
0/42
|
|
Gastrointestinal disorders
GI obstruction
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Obstruction gastric
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Liver abscess
|
0.00%
0/42
|
4.8%
2/42 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
2.4%
1/42 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Biliary tract infection
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
Infections and infestations
Bronchitis
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
Infections and infestations
Device related infection
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Infection
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Otitis media
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
Infections and infestations
Subdiaphragmatic abscess
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
Infections and infestations
Urinary tract infection
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/42
|
4.8%
2/42 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Fleural effusion
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Pyrexia
|
2.4%
1/42 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Disease progression
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
4.8%
2/42 • Number of events 2
|
4.8%
2/42 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
Hepatobiliary disorders
Jaundice
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
Cardiac disorders
Acute coronary syndrome
|
4.8%
2/42 • Number of events 2
|
0.00%
0/42
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
Investigations
Blood cortisol decreased
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
Investigations
Transaminase increased
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
1/42 • Number of events 1
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor associated fever
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
Psychiatric disorders
Mental status changes
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
General disorders
Pleural effusion
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
Vascular disorders
Embolism
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
Other adverse events
| Measure |
Control Group
n=42 participants at risk
trastuzumab + paclitaxel
|
Experimental Group
n=42 participants at risk
MM-111 + trastuzumab + paclitaxel
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
28.6%
12/42 • Number of events 12
|
52.4%
22/42 • Number of events 22
|
|
Gastrointestinal disorders
Nausea
|
26.2%
11/42 • Number of events 11
|
26.2%
11/42 • Number of events 11
|
|
Gastrointestinal disorders
Constipation
|
16.7%
7/42 • Number of events 7
|
14.3%
6/42 • Number of events 6
|
|
Gastrointestinal disorders
Vomiting
|
11.9%
5/42 • Number of events 5
|
31.0%
13/42 • Number of events 13
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
7/42 • Number of events 7
|
4.8%
2/42 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
4.8%
2/42 • Number of events 2
|
11.9%
5/42 • Number of events 5
|
|
Gastrointestinal disorders
Dysphagia
|
2.4%
1/42 • Number of events 1
|
14.3%
6/42 • Number of events 6
|
|
Gastrointestinal disorders
Stomatitis
|
7.1%
3/42 • Number of events 3
|
9.5%
4/42 • Number of events 4
|
|
Gastrointestinal disorders
Ascites
|
2.4%
1/42 • Number of events 1
|
7.1%
3/42 • Number of events 3
|
|
General disorders
Fatigue
|
21.4%
9/42 • Number of events 9
|
33.3%
14/42 • Number of events 14
|
|
General disorders
Asthenia
|
19.0%
8/42 • Number of events 8
|
16.7%
7/42 • Number of events 7
|
|
General disorders
Oedema peripheral
|
16.7%
7/42 • Number of events 7
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Pyrexia
|
7.1%
3/42 • Number of events 3
|
11.9%
5/42 • Number of events 5
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.8%
10/42 • Number of events 10
|
40.5%
17/42 • Number of events 17
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.4%
1/42 • Number of events 1
|
9.5%
4/42 • Number of events 4
|
|
Metabolism and nutrition disorders
Dehydration
|
4.8%
2/42 • Number of events 2
|
7.1%
3/42 • Number of events 3
|
|
Nervous system disorders
Neuropathy peripheral
|
9.5%
4/42 • Number of events 4
|
9.5%
4/42 • Number of events 4
|
|
Nervous system disorders
Dysgeusia
|
4.8%
2/42 • Number of events 2
|
11.9%
5/42 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Peripheral sensory neuropathy
|
7.1%
3/42 • Number of events 3
|
7.1%
3/42 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
4.8%
2/42 • Number of events 2
|
9.5%
4/42 • Number of events 4
|
|
Nervous system disorders
Headache
|
9.5%
4/42 • Number of events 4
|
4.8%
2/42 • Number of events 2
|
|
Nervous system disorders
Neurotoxicity
|
7.1%
3/42 • Number of events 3
|
4.8%
2/42 • Number of events 2
|
|
Nervous system disorders
Paraesthesia
|
2.4%
1/42 • Number of events 1
|
7.1%
3/42 • Number of events 3
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
14/42 • Number of events 14
|
35.7%
15/42 • Number of events 15
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
7/42 • Number of events 7
|
16.7%
7/42 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
7/42 • Number of events 7
|
42.9%
18/42 • Number of events 18
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
3/42 • Number of events 3
|
9.5%
4/42 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
6/42 • Number of events 6
|
16.7%
7/42 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.4%
1/42 • Number of events 1
|
9.5%
4/42 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
1/42 • Number of events 1
|
9.5%
4/42 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.8%
2/42 • Number of events 2
|
7.1%
3/42 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/42
|
7.1%
3/42 • Number of events 3
|
|
Investigations
Neutrophil count decreased
|
9.5%
4/42 • Number of events 4
|
19.0%
8/42 • Number of events 8
|
|
Investigations
Weight decreased
|
4.8%
2/42 • Number of events 2
|
9.5%
4/42 • Number of events 4
|
|
Investigations
White blood cell count decreased
|
2.4%
1/42 • Number of events 1
|
7.1%
3/42 • Number of events 3
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
3/42 • Number of events 3
|
2.4%
1/42 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
7.1%
3/42 • Number of events 3
|
2.4%
1/42 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.5%
4/42 • Number of events 4
|
7.1%
3/42 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/42
|
7.1%
3/42 • Number of events 3
|
|
Psychiatric disorders
Insomnia
|
11.9%
5/42 • Number of events 5
|
14.3%
6/42 • Number of events 6
|
|
Psychiatric disorders
Anxiety
|
7.1%
3/42 • Number of events 3
|
4.8%
2/42 • Number of events 2
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/42
|
7.1%
3/42 • Number of events 3
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/42
|
7.1%
3/42 • Number of events 3
|
|
Eye disorders
Conjunctivitis
|
7.1%
3/42 • Number of events 3
|
0.00%
0/42
|
Additional Information
MM-111 Medical Director
Merrimack Pharmaceuticals
Phone: 617-441-1000
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place