A Study of MEK162 and AMG 479 in Patients With Selected Solid Tumors

NCT01562899

Last updated date
Study Location
Massachusetts General Hospital Mass General 2
Boston, Massachusetts, 02114, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Pancreatic Adenocarcinoma, BRAF Mutated Melanoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Metastatic Pancreatic Adenocarcinoma, BRAF Mutated MelanomaA Study of MEK162 and AMG 479 in Patients With Selected Solid Tumors
NCT01562899
  1. Boston, Massachusetts
  2. Salt Lake City, Utah
  3. Parkville, Victoria
  4. Leuven,
  5. Toronto, Ontario
  6. Toulouse Cedex 9,
  7. Napoli,
  8. Barcelona, Catalunya
  9. Sutton, Surrey
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of MEK162 and AMG 479 in Patients With Selected Solid Tumors
Official Title  ICMJE 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
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Pancreatic Adenocarcinoma
  • BRAF Mutated Melanoma
Intervention  ICMJE
  • Drug: MEK162
    Supplied as tablets of dosage strength 15 mg in high-density polyethylene bottles with child-resistant closure.
    Other Name: Binimetinib
  • Drug: AMG 479
    Supplied as sterile liquid for intravenous infusion in vials in boxes. Until April 2013 a frozen formulation with a concentration of 30 mg/ml was used; from May 2013 onwards a refrigerated formulation with a concentration of 70 mg/ml was used.
    Other Name: Ganitumab
Study Arms  ICMJE
  • Experimental: Dose escalation
    Dose finding group chosen in order to establish a safe and tolerated dose of binimetinib in combination with ganitumab in patients with selected advanced solid tumors.
    Interventions:
    • Drug: MEK162
    • Drug: AMG 479
  • Experimental: KRAS mutated colorectal adenocarcinoma

    Patients with KRAS mutant colorectal cancer.

    The starting dose (30 mg bid) of binimetinib chosen for this study was a fraction of the MTD (60 mg bid) and the RP2D (45 mg bid) determined for single agent use. The starting dose for ganitumab was 12 mg/kg q2w which had been shown to be a well-tolerated dose in combination with other anti-cancer agents.

    Interventions:
    • Drug: MEK162
    • Drug: AMG 479
  • Experimental: Metastatic pancreatic adenocarcinoma

    Patients with metastatic pancreatic cancer.

    The starting dose (30 mg bid) of binimetinib chosen for this study was a fraction of the MTD (60 mg bid) and the RP2D (45 mg bid) determined for single agent use. The starting dose for ganitumab was 12 mg/kg q2w which had been shown to be a well-tolerated dose in combination with other anti-cancer agents.

    Interventions:
    • Drug: MEK162
    • Drug: AMG 479
  • Experimental: BRAF mutated melanoma

    Patients with mutant BRAF V600 melanoma.

    The starting dose (30 mg bid) of binimetinib chosen for this study was a fraction of the MTD (60 mg bid) and the RP2D (45 mg bid) determined for single agent use. The starting dose for ganitumab was 12 mg/kg q2w which had been shown to be a well-tolerated dose in combination with other anti-cancer agents.

    Interventions:
    • Drug: MEK162
    • Drug: AMG 479
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 31, 2014)
77
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2012)
91
Actual Study Completion Date  ICMJE April 1, 2015
Actual Primary Completion Date April 1, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   France,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT01562899
Other Study ID Numbers  ICMJE CMEK162X2111
C4211010 ( Other Identifier: Alias Study Number )
2012-000305-76 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP