AZD6244 + Chemotherapy for Advanced Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new cancer treatment by combining AZD6244, an oral medication, with standard chemotherapy. The study aims to determine if this combination is safe for individuals with advanced solid tumors and to identify the highest tolerable dose. Researchers will also examine how the body absorbs and processes the drugs. Individuals with advanced cancer who can swallow pills may be suitable candidates for this trial, particularly if other treatment options are unavailable. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it does exclude those who have taken a MEK inhibitor before, so you may need to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining AZD6244 with various chemotherapy drugs is generally safe. In one study, patients taking AZD6244 with docetaxel experienced manageable side effects. Another study found that when AZD6244 was used with dacarbazine, common side effects included nausea and rash, but these were not severe for most participants.
Similarly, when AZD6244 was combined with erlotinib or temsirolimus, side effects were mostly mild to moderate. Common issues included diarrhea, rash, and fatigue. These side effects were manageable and did not prevent participants from continuing treatment.
Overall, the safety data suggest that while some side effects occur, the treatment combinations are generally well-tolerated. It is important to consult a healthcare provider about any concerns before joining a trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about AZD6244 because it targets a specific pathway in cancer cells called the MAPK/ERK pathway, which plays a key role in cell growth and survival. Unlike traditional chemotherapy drugs that target rapidly dividing cells more broadly, AZD6244 offers a more targeted approach by specifically inhibiting this pathway, potentially leading to fewer side effects. Moreover, when combined with other treatments like docetaxel, dacarbazine, erlotinib, or temsirolimus, AZD6244 could enhance their effectiveness by overcoming resistance mechanisms that cancer cells often develop. This targeted approach could mean better outcomes for patients with advanced cancer, offering a promising alternative to existing treatments.
What evidence suggests that this trial's treatments could be effective for advanced cancer?
This trial will evaluate the effectiveness of AZD6244 combined with different chemotherapy drugs for treating advanced cancers. Research has shown that combining AZD6244 with these drugs may improve outcomes. For instance, participants receiving AZD6244 with docetaxel may experience longer periods without cancer worsening, as one study found an increase from 2.8 months to 3.9 months compared to chemotherapy alone. Another arm of the trial will test AZD6244 with dacarbazine, where patients have experienced more stable disease conditions. Trials with AZD6244 and erlotinib have shown some improvement in controlling tumors for certain patients. Additionally, early research with AZD6244 and temsirolimus suggests it might be more effective against tumors, though more information is needed. Overall, AZD6244 shows promise when used with these chemotherapy drugs in the various treatment arms of this trial.12356
Who Is on the Research Team?
Jeffrey Infante, MD
Principal Investigator
SCRI Development Innovations, LLC
Patricia LoRusso, DO
Principal Investigator
Barbara Ann Karmanos Cancer Institute
Roger Cohen, MD
Principal Investigator
Fox Chase Cancer Center
Kevin Kim, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for cancer patients with advanced solid tumors who have a good performance status, measurable disease, and no curative options left. They must be able to swallow pills and not have used MEK inhibitors before or been in another study within the last month.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive AZD6244 in combination with standard doses of selected chemotherapies to assess safety, tolerability, and pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AZD6244
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology