A Study of MM-111 and Paclitaxel With or Without Trastuzumab in Patients HER2 Expressing Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach
This study is not yet open for participant recruitment.
Verified January 2013 by Merrimack Pharmaceuticals
Sponsor:
Merrimack Pharmaceuticals
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01774851
First received: January 10, 2013
Last updated: January 23, 2013
Last verified: January 2013
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Purpose
To determine whether the combination of MM-111 plus paclitaxel and trastuzumab is more effective than paclitaxel and trastuzumab alone for group 1 and to determine whether the combination of MM-111 plus paclitaxel is more effective than paclitaxel alone for group 2.
| Condition | Intervention | Phase |
|---|---|---|
|
HER-2 Gene Amplification Esophagus Cancer Gastroesophageal Junction Cancer Stomach Cancer |
Drug: MM-111 Drug: Paclitaxel Drug: Trastuzumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized, Open Label, Phase 2 Study of MM-111 and Paclitaxel With or Without Trastuzumab in Patients With 'Traditional' and 'Non-Traditional' HER2 Expressing Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front Line Metastatic or Locally Advanced Therapy |
Resource links provided by NLM:
Further study details as provided by Merrimack Pharmaceuticals:
Primary Outcome Measures:
- Progression Free Survival (PFS) [ Time Frame: The outcome of PFS will be measured montly for an estimate of 22 months after the first 50 patients are enrolled. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 180 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1a
MM-111 + Paclitaxel + Trastuzumab
|
Drug: MM-111
MM-111 (IV)
Drug: Paclitaxel
Paclitaxel (IV)
Drug: Trastuzumab
Trastuzumab (IV)
|
|
Active Comparator: Arm 1b
Paclitaxel + Trastuzumab
|
Drug: Paclitaxel
Paclitaxel (IV)
Drug: Trastuzumab
Trastuzumab (IV)
|
|
Experimental: Arm 2a
MM-111 + Paclitaxel
|
Drug: MM-111
MM-111 (IV)
Drug: Paclitaxel
Paclitaxel (IV)
|
|
Active Comparator: Arm 2b
Paclitaxel
|
Drug: Paclitaxel
Paclitaxel (IV)
|
Detailed Description:
This is a randomized, open Label, Phase 2 Study of MM-111 and Paclitaxel with or without Trastuzumab in Patients with 'Traditional' and 'Non-Traditional' HER2 Expressing Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach Who Have Failed Front Line Metastatic or Locally Advanced Therapy. Up to 180 patients will be randomized in a 1:1 ratio between the experimental and comparator arms within each group.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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 as follows
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774851
Contacts
| Contact: Sasha Frye | 617-441-7667 | sfrye@merrimackpharma.com |
| Contact: Kate-Lyn Best | 617-441-7670 | kbest@merrimackpharma.com |
Locations
| United States, Pennsylvania | |
| Fox Chase Cancer Center | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Contact: Joan Leahy 215-214-1472 joan.bloch@fccc.edu | |
| Principal Investigator: Crystal Denlinger, D | |
Sponsors and Collaborators
Merrimack Pharmaceuticals
Investigators
| Study Director: | Victor Moyo, MD | Merrimack Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Merrimack Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01774851 History of Changes |
| Other Study ID Numbers: | MM-111-13-02-04 |
| Study First Received: | January 10, 2013 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma Stomach Neoplasms Esophageal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |
Head and Neck Neoplasms Esophageal Diseases Paclitaxel Trastuzumab Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013