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

AstraZeneca

Status and phase: Active, not recruiting; Phase 1

Conditions: Breast Cancer; Melanoma; Colon Neoplasms; Colonic Cancer; Colon Cancer; Kidney Cancer; Lung Cancer; Breast Neoplasms

Treatments: Drug: Erlotinib; Drug: Temsirolimus; Drug: AZD6244; Drug: Dacarbazine; Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00600496

D1532C00004

Details and patient eligibility

About

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

Enrollment: 140 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 4 patient groups

1

Experimental group

Description:

AZD6244 + docetaxel

Treatment:

Drug: Docetaxel

Drug: AZD6244

2

Experimental group

Description:

AZD6244 + Dacarbazine

Treatment:

Drug: Dacarbazine

Drug: AZD6244

3

Experimental group

Description:

AZD6244 + Erlotinib

Treatment:

Drug: AZD6244

Drug: Erlotinib

4

Experimental group

Description:

AZD6244 + Temsirolimus

Treatment:

Drug: AZD6244

Drug: Temsirolimus