Clinical trial NCT01774851: A Study of MM-111 and Paclitaxel With Trastuzumab in Patients HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: HER-2 Gene Amplification
Esophagus Cancer
Gastroesophageal Junction Cancer
Stomach Cancer
Keywords: HER-2 Gene Amplification
Esophagus Cancer
Gastroesophageal Junction Cancer
Stomach Cancer
Her2 Positive
Her2+
Esophageal Cancer
Metastatic
Lead sponsor: Merrimack Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-01-24
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Stanford
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Ocala
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Urbana
country: United States
state: Illinois
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Rochester
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Buffalo
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Wenatchee
country: United States
state: Washington
Study officials:
affiliation: Merrimack Pharmaceuticals
name: Akos Czibere, MD, PhD
role: STUDY_DIRECTOR
References: