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A Study of MM-111 and Paclitaxel With Trastuzumab in Patients HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach

Randomized, Open Label, Phase 2 Study of MM-111 and Paclitaxel With Trastuzumab in Patients With HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front Line Metastatic or Locally Advanced Therapy

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01774851
Enrollment
84
Registered
2013-01-24
Start date
2013-01-31
Completion date
2015-12-31
Last updated
2017-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagus Cancer, Gastroesophageal Junction Cancer, HER-2 Gene Amplification, Stomach Cancer

Keywords

HER-2 Gene Amplification, Esophagus Cancer, Gastroesophageal Junction Cancer, Stomach Cancer, Her2 Positive, Her2+, Esophageal Cancer, Metastatic

Brief summary

To determine whether the combination of MM-111 plus paclitaxel and trastuzumab is more effective than paclitaxel and trastuzumab alone

Detailed description

This is a randomized, open Label, Phase 2 Study of MM-111 and Paclitaxel withTrastuzumab in Patients with HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front Line Metastatic or Locally Advanced Therapy. Approximately 120 patients will be randomized in a 1:1 ratio between the experimental and comparator arms.

Interventions

DRUGMM-111

MM-111 (IV)

DRUGPaclitaxel

Paclitaxel (IV)

DRUGTrastuzumab

Trastuzumab (IV)

Sponsors

Merrimack Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients must have documentation of histologically or cytologically confirmed metastatic or locally advanced adenocarcinoma of the distal esophagus, GE junction or stomach * Patients must have documentation of histologically or cytologically confirmed HER2 expression * Patients must be ≥18 years of age * Patients must have ECOG PS of 0, 1, or 2 * Patients must have adequate hematologic status, renal and hepatic function

Exclusion criteria

* Patients with known hypersensitivity to any of the components of MM-111 * Patients with a known history of hypersensitivity to paclitaxel or other drugs formulated in Cremophor® EL * Patients with a known history of hypersensitivity to trastuzumab or any of its components (group 1 patients only) * Patients with an active infection or with an unexplained fever \>38.5°C

Design outcomes

Primary

MeasureTime frameDescription
Progression Free Survival (PFS)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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Control Group
Trastuzumab + paclitaxel
42
Experimental Group
MM-111 + trastuzumab + paclitaxel
42
Total84

Baseline characteristics

CharacteristicControl GroupTotalExperimental Group
Age, Continuous62.5 years63 years63.5 years
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants2 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
41 Participants82 Participants41 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Height172 cm171 cm170.19 cm
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
12 Participants23 Participants11 Participants
Race (NIH/OMB)
Black or African American
0 Participants2 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
30 Participants59 Participants29 Participants
Region of Enrollment
Denmark
0 participants1 participants1 participants
Region of Enrollment
France
1 participants1 participants0 participants
Region of Enrollment
Korea, Republic of
11 participants21 participants10 participants
Region of Enrollment
Spain
9 participants17 participants8 participants
Region of Enrollment
Taiwan
2 participants4 participants2 participants
Region of Enrollment
United Kingdom
6 participants14 participants8 participants
Region of Enrollment
United States
13 participants26 participants13 participants
Sex: Female, Male
Female
2 Participants7 Participants5 Participants
Sex: Female, Male
Male
40 Participants77 Participants37 Participants
Subject of child bearing potential0 Participants2 Participants2 Participants
Weight73.97 kg72.51 kg68 kg

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
18 / 4211 / 42
other
Total, other adverse events
26 / 4239 / 42
serious
Total, serious adverse events
16 / 4219 / 42

Outcome results

Primary

Progression Free Survival (PFS)

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.

Time frame: 30 months

ArmMeasureValue (MEDIAN)
Control GroupProgression Free Survival (PFS)23.3 weeks
Experimental GroupProgression Free Survival (PFS)9.6 weeks

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026