A Phase I, Open-Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886)

Part of paid clinical trials in Detroit, Michigan.

Sponsor
AstraZeneca
Study ID
NCT00600496
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • AZD6244 — DRUG
    twice daily oral dose
  • Dacarbazine — DRUG
    intravenous infusion
  • Erlotinib — DRUG
    daily oral dose
  • Docetaxel — DRUG
    intravenous infusion
  • Temsirolimus — DRUG
    intravenous infusion

Study Details

This study is being conducted to determine if a combination of AZD6244 given orally twice a day with standard doses of selected chemotherapies will be safe and tolerable for cancer patients with advanced solid tumors. The highest tolerated dose of AZD6244 in combination with selected chemotherapies will be evaluated. The study will also investigate how AZD6244 in combination with standard chemotherapies are absorbed, distributed and excreted by the body as well as the length of time that the drugs remain in the body. Initial and periodic assessments will establish patient response to the combination therapies

Key Dates

First listed
Jan 25, 2008
Start date
Dec 14, 2007
Status verified
Mar 2026
Primary completion
Aug 20, 2010
Completion
Dec 18, 2025

Study Design

Enrollment
140 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    AZD6244 + docetaxel
  • Experimental: 2
    AZD6244 + Dacarbazine
  • Experimental: 3
    AZD6244 + Erlotinib
  • Experimental: 4
    AZD6244 + Temsirolimus

Primary Outcome Measure

Safety and tolerability of twice daily oral doses of AZD6244 when administered in combination with standard doses of selected chemotherapies. [ Time Frame: 28 days + ]

Locations (4)

FacilityCityStateZIPSite coordinators
Research SiteDetroitMichigan48201-
Research SitePhiladelphiaPennsylvania19111-
Research SiteNashvilleTennessee37203-
Research SiteHoustonTexas77030-

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