Clinical trial · Interventional
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
NCT01774851CI-TRIAL-00028224terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): DSMB recommendation due to lack of efficacy. There were no safety signals.
Summary
Brief summary (as posted)
To determine whether the combination of MM-111 plus paclitaxel and trastuzumab is more effective than paclitaxel and trastuzumab alone
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophagus Cancer | — | UNRESOLVED | — |
| Gastroesophageal Junction Cancer | — | UNRESOLVED | — |
| HER-2 Gene Amplification | — | UNRESOLVED | — |
| Stomach Cancer | Malignant Gastric Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MM-111 | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1a
- description
- MM-111 + Paclitaxel + Trastuzumab
- interventionNames
- Drug: MM-111
- Drug: Paclitaxel
- Drug: Trastuzumab
- type
- ACTIVE_COMPARATOR
- label
- Arm 1b
- description
- Paclitaxel + Trastuzumab
- interventionNames
- Drug: Paclitaxel
- Drug: Trastuzumab
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- 30 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.