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A Phase I, Open-Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886) When Given in Combination With Standard Doses of Selected Chemotherapies to Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Breast Neoplasms, Colon Cancer, Colonic Cancer, Colon Neoplasms, Lung Cancer, Melanoma, Kidney Cancer

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Trial Information

A Phase I, Open-Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886) When Given in Combination With Standard Doses of Selected Chemotherapies to Patients With Advanced Solid Tumors


Inclusion Criteria:



- Patients will have measurable and/or non-measurable disease, lacking curative options
for whom the selected chemotherapy agents represent the standard of care

- WHO performance status 0-1

- Patients must be able to swallow AZD6244 capsules

Exclusion Criteria:

- Prior treatment with a MEK inhibitor

- Participation in a clinical study during the last 30 days or have not recovered from
side effects of an investigational study drug

- Brain metastases or spinal cord compression unless treated and stable (for at least 1
month) off steroids

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of twice daily oral doses of AZD6244 when administered in combination with standard doses of selected chemotherapies.

Outcome Description:

Incidence and intensity of adverse events as graded by CTCAE (version 3.0), physical examinations, vital signs (including weight, blood pressure and pulse rate), ECG parameters, MUGA scan and echocardiography, clinical chemistry (including liver function tests), Brain Natriuretic Peptide (BNP), Troponin I, hematology, urinalysis, and ophthalmologic examinations.

Outcome Time Frame:

28 days +

Safety Issue:

Yes

Principal Investigator

Patricia LoRusso, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

Karmanos Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

D1532C00004

NCT ID:

NCT00600496

Start Date:

December 2007

Completion Date:

August 2013

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms
  • Colon Cancer
  • Colonic Cancer
  • Colon Neoplasms
  • Lung Cancer
  • Melanoma
  • Kidney Cancer
  • ARRY-142886
  • AZD6244
  • Cancer
  • Colon Cancer
  • Breast Cancer
  • Lung Cancer
  • Melanoma
  • Kidney Cancer
  • Breast Neoplasms
  • Neoplasms
  • Colonic Neoplasms
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Lung Neoplasms
  • Melanoma

Name

Location

Research SiteBattle Kreek, Michigan  
Research SiteAllentown, Pennsylvania  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas