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A Phase Ib/II Open-label, Multi-center Study of the Combination of MEK162 Plus AMG 479 (Ganitumab) in Adult Patients With Selected Advanced Solid Tumors


Phase 2
18 Years
N/A
Open (Enrolling)
Both
KRAS Mutated Colorectal Adenocarcinoma., Metastatic Pancreatic Adenocarcinoma, BRAF Mutated Melanoma

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Trial Information

A Phase Ib/II Open-label, Multi-center Study of the Combination of MEK162 Plus AMG 479 (Ganitumab) in Adult Patients With Selected Advanced Solid Tumors


Inclusion Criteria:



- Patients aged ≥ 18 years

- Patients with advanced solid tumors (CRC, melanoma) with documented somatic KRAS or
BRAFV600 mutations in tumor tissue. Patients with metastatic pancreatic
adenocarcinoma may be enrolled irrespectively of KRAS or BRAFV600 mutational status.

- Patients must have relapsed or progressed following standard therapy or patients for
whom no standard anticancer therapy exists.

- Measurable disease as determined by RECIST v1.1. World Health Organization (WHO)
Performance Status (PS) ≤ 2.

- Adequate organ function

- Negative serum pregnancy test

Exclusion Criteria:

- Prior therapy with MEK- or IGF-1R- inhibitor

- History or current evidence of central serous retinopathy (CSR), retinal vein
occlusion (RVO) or retinal degenerative disease

- Patients with known history of severe infusion reactions to monoclonal antibodies

- Patients with primary CNS tumor or CNS tumor involvement

- History of thromboembolic event requiring full-dose anticoagulation therapy

- Clinically significant cardiac disease

- History of another malignancy within 2 years

- Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase Ib: Estimation of Maximum Tolerated Doses (MTDs) and/or recommended Phase II doses (RP2Ds) by measuring incidence of dose limiting toxicities

Outcome Description:

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)

Outcome Time Frame:

Approximately 6 months

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CMEK162X2111

NCT ID:

NCT01562899

Start Date:

August 2012

Completion Date:

September 2014

Related Keywords:

  • KRAS Mutated Colorectal Adenocarcinoma.
  • Metastatic Pancreatic Adenocarcinoma
  • BRAF Mutated Melanoma
  • MEK162
  • AMG 479
  • Ganitumab
  • colorectal adenocarcinoma
  • pancreatic adenocarcinoma
  • melanoma
  • KRAS
  • BRAF
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Melanoma
  • Colorectal Neoplasms

Name

Location

University of Utah / Huntsman Cancer Institute HuntsmanSalt Lake City, Utah  84103
Massachusetts General Hospital Mass General 2Boston, Massachusetts  02114