Clinical Trials Logo

Clinical Trial Summary

This phase I trial is studying the side effects and the best dose of MEK Inhibitor AZD6244 when given together with cetuximab in patients with advanced or refractory solid tumors that cannot be removed by surgery. MEK inhibitor AZD6244 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving MEK Inhibitor AZD6244 together with cetuximab may kill more tumor cells.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine the dose limiting toxicities and the maximum tolerated dose of AZD6244 in combination with cetuximab in advanced, refractory solid tumors.

II. To assess for evidence of anti-tumor activity with this combination, per tumor measurements using RECIST criteria.

SECONDARY OBJECTIVES:

I. To evaluate the pharmacokinetics of AZD6244 and cetuximab when administered concomitantly.

II. To evaluate the safety and tolerability of the combination of AZD6244 and cetuximab in patients with K-RAS mutated metastatic colorectal cancer.

TERTIARY OBJECTIVES:

I. To assess the inhibition of the RAF/MEK/ERK pathway in peripheral blood mononuclear cells secondary to treatment with AZD6244.

II. To evaluate the pharmacokinetics of AZD6244 in combination with cetuximab and the relation to treatment side effects.

OUTLINE: This is a dose-escalation study of MEK inhibitor AZD6244.

Patients receive oral MEK inhibitor AZD6244 once or twice daily on days 1-28 and cetuximab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and periodically during study for pharmacokinetic and biomarker analyses.

After completion of study treatment, patients are followed up for 1 month or every 3 months for 1 year. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01217450
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 1
Start date October 2012
Completion date May 2014

See also
  Status Clinical Trial Phase
Completed NCT01828775 - Palliative Care Intervention in Improving Quality of Life, Psychological Distress, and Communication in Patients With Solid Tumors Receiving Treatment N/A
Terminated NCT01642342 - Recombinant Albumin Fusion Protein sEphB4-HSA in Treating Patients With Metastatic or Recurrent Solid Tumors Phase 1
Completed NCT00002950 - Topotecan Plus Sargramostim in Treating Patients With Advanced Cancer Phase 1/Phase 2
Completed NCT01705548 - Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis N/A
Completed NCT02146222 - VEGFR/PDGFR Dual Kinase Inhibitor X-82 and Docetaxel in Treating Patients With Solid Tumors Phase 1
Terminated NCT01602627 - Hsp90 Inhibitor AUY922 in Treating Older Patients With Advanced Solid Malignancies Phase 1
Completed NCT01191216 - 1-Methyl-D-Tryptophan and Docetaxel in Treating Patients With Metastatic Solid Tumors Phase 1
Recruiting NCT01137825 - Registry of Older Patients With Cancer
Recruiting NCT00992303 - Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy and Healthy Participants
Completed NCT00949949 - Everolimus, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Unresectable Solid Tumors Refractory to Standard Therapy Phase 1
Suspended NCT00935090 - 3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer N/A
Completed NCT00924651 - Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy Phase 3
Withdrawn NCT00937417 - S0716 Vandetanib and Docetaxel in Treating Patients With Advanced Solid Tumors Phase 1
Active, not recruiting NCT00710632 - Screening to Predict Weight Loss in Patients With Cancer N/A
Completed NCT00544596 - R-(-)-Gossypol Acetic Acid, Cisplatin, and Etoposide in Treating Patients With Advanced Solid Tumors or Extensive Stage Small Cell Lung Cancer Phase 1
Completed NCT00573690 - Sorafenib Combined With Cisplatin and Etoposide or Carboplatin and Pemetrexed in Treating Patients With Metastatic Solid Tumors Phase 1
Active, not recruiting NCT00436735 - Nelfinavir in Treating Patients With Metastatic, Refractory, or Recurrent Solid Tumors Phase 1
Completed NCT00352443 - S0528 Lapatinib and Everolimus in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma Phase 1
Completed NCT00121277 - Vorinostat and Capecitabine in Treating Patients With Metastatic or Unresectable Solid Tumors Phase 1
Completed NCT00128622 - Denileukin Diftitox Followed by Vaccine Therapy in Treating Patients With Metastatic Cancer Phase 1