A Phase I Study of Oral MEK162 in Japanese Patients With Advanced Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01469130
First received: November 8, 2011
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

In this study, MEK162 will be administered to Japanese patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will investigate the safety and tolerability and determine the MTD of MEK162 in Japanese patients.


Condition Intervention Phase
Advanced Solid Tumor
Drug: MEK162
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Oral MEK162 in Japanese Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Incidence of Dose limiting toxicities [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Incidence of frequency of Dose limiting toxicities during first 4 weeks will be measured according to the commen terminology criteria for adverse events (CTCAE).


Secondary Outcome Measures:
  • Incidence and severity of adverse events and serious adverse events, changes in laboratory values [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    Incidence and severity of adverse events and serious adverse events, changes in laboratory values will be measured during the treatment.

  • Plasma concentration of MEK162 and AR00426032active metabolite of MEK162 and derived PK parameters of MEK162 and the active metabolite. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Plasma concentration of MEK162 and active metabolite of MEK162 and derived PK parameters of MEK162 and the active metabolite will be measured with serial plasma samples during treatment for first 2 months.

  • Tumor responses according to RECIST 1.1 [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Tumor responses will be measured according to RECIST 1.1

  • Levels of p-ERK in tumor and skin [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Levels of p-ERK in tumor during treatment and skin for first 2 weeks will be measured.


Enrollment: 21
Study Start Date: November 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEK162

MEK162 will be administered orally once on Day 1 of Cycle 1 and continuously on a BID schedule, starting on Day 2 of Cycle 1 and on Day 1 of subsequent cycles. Each cycle will be 28 days in duration. Dose will be escalated and starting dose is 30 mg. Any doses that are missed should be skipped and should not be replaced or made up during the evening dosing or on a subsequent day, whichever applies.

The prescribed BID doses should be taken 12 ± 2 hrs apart.

Drug: MEK162
MEK162 in an oral formulation. It is a film-coated capsule-shape tablets (i.e. caplets).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histologically-confirmed, advanced unresectable solid tumors who have progressed within three months before screening/baseline visit.
  • Availability of a representative formalin fixed paraffin embedded tumor tissue sample.
  • At least one measurable or non-measurable lesion
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
  • Good organ (hepatic, kidney, BM) function at screening/baseline visit.

Exclusion Criteria:

  • Brain metastasis unless treated and free of signs/symptoms attributable to brain metastasis in the absence of corticosteroid therapy and anti-epileptic therapy.
  • Impaired cardiac function or clinically significant cardiac disease incl. unstable angina pectoris ≤ 3 months prior to starting study drug and Acute Myocardial Infarction (AMI) ≤ 3 months prior to starting study drug.
  • Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01469130

Locations
Japan
Novartis Investigative Site
Nagoya-city, Aichi, Japan, 466-8560
Novartis Investigative Site
Yufu, Oita, Japan, 879-5593
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01469130     History of Changes
Other Study ID Numbers: CMEK162X1101
Study First Received: November 8, 2011
Last Updated: October 18, 2013
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:
MEK, Advanced solid tumor

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014