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

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

Sponsors

Lead Sponsor: AstraZeneca

Source AstraZeneca
Brief Summary

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.

Overall Status Active, not recruiting
Start Date 2007-12-14
Completion Date 2021-12-31
Primary Completion Date 2010-08-20
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Safety and tolerability of twice daily oral doses of AZD6244 when administered in combination with standard doses of selected chemotherapies. 28 days +
Secondary Outcome
Measure Time Frame
PK of AZD6244 and selected chemotherapies. Cycle 1 Day 3 and Cycle 2 day 1
Define highest tolerated dose of AZD6244 when in combination with selected chemotherapies. 28 days +
Tumor response. 28 days +
Enrollment 140
Condition
Intervention

Intervention Type: Drug

Intervention Name: AZD6244

Description: twice daily oral dose

Other Name: ARRY-142886

Intervention Type: Drug

Intervention Name: Dacarbazine

Description: intravenous infusion

Arm Group Label: 2

Intervention Type: Drug

Intervention Name: Erlotinib

Description: daily oral dose

Arm Group Label: 3

Intervention Type: Drug

Intervention Name: Docetaxel

Description: intravenous infusion

Arm Group Label: 1

Other Name: Taxotere®

Intervention Type: Drug

Intervention Name: Temsirolimus

Description: intravenous infusion

Arm Group Label: 4

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

130 Years

Healthy Volunteers:

No

Overall Official
Location
Facility:
Research Site | Detroit, Michigan, 48201, United States
Research Site | Philadelphia, Pennsylvania, 19111, United States
Research Site | Nashville, Tennessee, 37203, United States
Research Site | Houston, Texas, 77030, United States
Location Countries

United States

Verification Date

2021-06-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: 1

Type: Experimental

Description: AZD6244 + docetaxel

Label: 2

Type: Experimental

Description: AZD6244 + Dacarbazine

Label: 3

Type: Experimental

Description: AZD6244 + Erlotinib

Label: 4

Type: Experimental

Description: AZD6244 + Temsirolimus

Patient Data Yes
Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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