Ignite Creation Date:
2024-05-06 @ 12:23 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01562899
Status:
TERMINATED
Last Update Posted:
2020-12-10
First Post:
2012-03-22
Brief Title:
A Study of MEK162 and AMG 479 in Patients With Selected Solid Tumors
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Phase IbII Open-label Multi-center Study of the Combination of MEK162 Plus AMG 479 Ganitumab in Adult Patients With Selected Advanced Solid Tumors
Status:
TERMINATED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was withdrawn due to scientific and business considerations
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-center open-label phase IbII study First the aim of the phase Ib part is to estimate the MTDs andor to identify the recommended phase II doses 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 MTDRP2D 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
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 MTDRP2D 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| C4211010 | OTHER | None | None |
| 2012-000305-76 | EUDRACT_NUMBER | Alias Study Number | None |