Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01562899 · ClinicalTrials.gov registry record · Phase 1
A Study of MEK162 and AMG 479 in Patients With Selected Solid Tumors
A Phase 1 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 1
- Development phase
- 77
- Enrollment target
NCT01562899: Clinical Trial Phase 1 study, sponsored by Pfizer.
NCT01562899 is a Phase 1 study that was terminated before completion, run by Pfizer. The registered enrollment target is 77 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01562899, a Phase 1 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 77 participants
- Enrollment target
Study Summary
This is a multi-center, open-label, phase Ib/II study. First, the aim of the phase Ib part is to estimate the MTD(s) and/or to identify the recommended phase II dose(s) (RP2D) for the combination of MEK162 and AMG 479 (ganitumab), followed by the phase II part to assess the clinical efficacy and to further assess the safety of the combination in selected patient populations. The dose escalation part of the study will be guided by a Bayesian Logistic Regression Model (BLRM). At least 18 patients are expected to be enrolled in the dose escalation part. Following MTD/ RP2D declaration, patients will be enrolled in three phase II arms to assess efficacy of the combination as well as to better understand the safety, tolerability, PK, antibody concentrations and PD of the combination at MTD/RP2D. Phase II arm 1 will consist of approximately 25 patients with KRAS-mutant colorectal adenocarcinoma. Phase II arm 2 will consist of approximately 20 patients with metastatic pancreatic adenocarcinoma. Phase II arm 3 will consist of approximately 28 patients with mutant BRAFV600 melanoma. Patients will be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurs first. All patients will be followed up - at minimum patients must complete the safety follow-up assessments 30 days after the last dose of the study treatment.
Primary Outcome
To estimate the MTDs and/or RP2Ds of MEK162 in combination with AMG479 by measuring incidence of dose limiting toxicities in Cycle 1 (Cycle 1 = 28 days)
Interventions
- DRUG MEK162
- DRUG AMG 479
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2012-08-27 |
| Est. Completion | 2015-04-01 |
| Phase | Phase 1 |
Why NCT01562899 stopped before completion
NCT01562899 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% higher).
The record links to 0 conditions, and to 2 interventions - of which MEK162 is the first listed.
NCT01562899 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01562899 about?
NCT01562899 is a clinical study titled "A Study of MEK162 and AMG 479 in Patients With Selected Solid Tumors". This is a multi-center, open-label, phase Ib/II study. First, the aim of the phase Ib part is to estimate the MTD(s) and/or to identify the recommended phase II dose(s) (RP2D) for the combination of MEK162 and AMG 479 (ganitumab), followed by the phase II part to assess the clinical efficacy and to ...
What is the current status of trial NCT01562899?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 77 participants. The study started on 2012-08-27. Estimated completion is 2015-04-01.
What interventions are being tested in trial NCT01562899?
The interventions under investigation include: MEK162 (DRUG), AMG 479 (DRUG).
Who is sponsoring clinical trial NCT01562899?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01562899's enrollment target sits among peer trials
77 703rd of 2000 higher than 1,296 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02127398 · 77 participants · Phase 2
Stool Transplants to Treat Refractory Clostridium Difficile Colitis
- NCT04159103 · 77 participants · Phase 1
Open-Label Study of mRNA-3927 in Participants With Propionic Acidemia
- NCT04683003 · 77 participants · Phase 3
A Study of TAK-755 in Participants With Congenital Thrombotic Thrombocytopenic Purpura
- NCT05004116 · 77 participants · Phase 1
A Study of Repotrectinib in Combination With Chemotherapy in Children and Young Adults With Solid Tumor Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI