A Study of MM-111 and Paclitaxel With Trastuzumab in Patients HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach
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| ClinicalTrials.gov Identifier: NCT01774851 |
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Recruitment Status :
Terminated
(DSMB recommendation due to lack of efficacy. There were no safety signals.)
First Posted : January 24, 2013
Results First Posted : June 22, 2017
Last Update Posted : June 22, 2017
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Sponsor:
Merrimack Pharmaceuticals
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
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Brief Summary:
To determine whether the combination of MM-111 plus paclitaxel and trastuzumab is more effective than paclitaxel and trastuzumab alone
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HER-2 Gene Amplification Esophagus Cancer Gastroesophageal Junction Cancer Stomach Cancer | Drug: MM-111 Drug: Paclitaxel Drug: Trastuzumab | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 84 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 Start Date : | January 2013 |
| Actual Primary Completion Date : | July 2015 |
| Actual Study Completion Date : | December 2015 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm 1a
MM-111 + Paclitaxel + Trastuzumab
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Drug: MM-111
MM-111 (IV) Drug: Paclitaxel Paclitaxel (IV) Drug: Trastuzumab Trastuzumab (IV) |
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Active Comparator: Arm 1b
Paclitaxel + Trastuzumab
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Drug: Paclitaxel
Paclitaxel (IV) Drug: Trastuzumab Trastuzumab (IV) |
Primary Outcome Measures :
- Progression Free Survival (PFS) [ Time Frame: 30 months ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01774851
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Locations
| United States, Alabama | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Los Angeles, California, United States, 90089 | |
| Los Angeles, California, United States, 90095 | |
| Stanford, California, United States, 94305 | |
| United States, Colorado | |
| Denver, Colorado, United States, 80218 | |
| United States, Florida | |
| Ocala, Florida, United States, 34471 | |
| Saint Petersburg, Florida, United States, 33705 | |
| United States, Illinois | |
| Urbana, Illinois, United States, 61801 | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States, 02111 | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Minnesota | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Nevada | |
| Las Vegas, Nevada, United States, 89135 | |
| United States, New York | |
| Buffalo, New York, United States, 14263 | |
| United States, North Carolina | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Cleveland, Ohio, United States, 44106 | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, Tennessee | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Washington | |
| Wenatchee, Washington, United States, 98801 | |
Sponsors and Collaborators
Merrimack Pharmaceuticals
Investigators
| Study Director: | Akos Czibere, MD, PhD | Merrimack Pharmaceuticals |
| Responsible Party: | Merrimack Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01774851 History of Changes |
| Other Study ID Numbers: |
MM-111-13-02-04 |
| First Posted: | January 24, 2013 Key Record Dates |
| Results First Posted: | June 22, 2017 |
| Last Update Posted: | June 22, 2017 |
| Last Verified: | June 2017 |
Keywords provided by Merrimack Pharmaceuticals:
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HER-2 Gene Amplification Esophagus Cancer Gastroesophageal Junction Cancer Stomach Cancer |
Her2 Positive Her2+ Esophageal Cancer Metastatic |
Additional relevant MeSH terms:
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Stomach Neoplasms Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Head and Neck Neoplasms |
Esophageal Diseases Paclitaxel Albumin-Bound Paclitaxel Trastuzumab Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |