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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 is a Phase 1 study that was terminated before completion, run by Pfizer. The registered enrollment target is 77 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01562899
The ClinicalTrials.gov registry entry for NCT01562899 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which MEK162 is the first listed.
NCT01562899 reports 0 study locations.
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.
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