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MEK Inhibitor

AZD6244 + Chemotherapy for Advanced Cancer

Phase 1
Waitlist Available
Led By Jeffrey Infante, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 day 3 and cycle 2 day 1
Awards & highlights

Study Summary

This trial is testing a new drug in combination with standard chemotherapies to see if it is safe and effective for treating advanced solid tumors.

Who is the study for?
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.Check my eligibility
What is being tested?
The trial tests AZD6244 taken orally twice daily alongside standard chemotherapy drugs like Temsirolimus, Dacarbazine, Erlotinib, and Docetaxel. It aims to find the highest dose of AZD6244 that's safe when combined with these chemotherapies.See study design
What are the potential side effects?
Potential side effects may include typical reactions from chemotherapy such as nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts; specific side effects related to AZD6244 are being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer can't be cured with surgery or radiation, and chemotherapy is the standard treatment for me.
Select...
I can carry out all my usual activities without help.
Select...
I can swallow capsules.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 day 3 and cycle 2 day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 day 3 and cycle 2 day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability of twice daily oral doses of AZD6244 when administered in combination with standard doses of selected chemotherapies.
Secondary outcome measures
Define highest tolerated dose of AZD6244 when in combination with selected chemotherapies.
Pharmacotherapy
Tumor response.

Side effects data

From 2020 Phase 2 trial • 334 Patients • NCT01248247
50%
Rash Acneiform
36%
Diarrhea
32%
Nausea
32%
Dry skin
27%
Anorexia
23%
Increased blood bilirubin
23%
Vomiting
23%
Increased AST
14%
Oral mucositis
14%
Weight loss
14%
Other skin and subcutaneous tissue disorders, specify
14%
Rash Maculopapular
14%
Epistaxis
9%
Fatigue
9%
Hyperglycemia
9%
Increased alkaline phosphatase
5%
Dry mouth
5%
Lung infection
5%
Pruritus
5%
Hyponatremia
5%
Dyspnea
5%
Palmar-plantar erythrodysesthesia syndrome
5%
Multi-organ failure
5%
Hypoalbuminemia
5%
Dysgeusia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1 - Erlotinib
Arm 3 - AZD6244 + MK-2206
Arm 4 - Sorafenib
Arm 2 - Erlotinib + MK-2206

Trial Design

4Treatment groups
Experimental Treatment
Group I: 4Experimental Treatment2 Interventions
AZD6244 + Temsirolimus
Group II: 3Experimental Treatment2 Interventions
AZD6244 + Erlotinib
Group III: 2Experimental Treatment2 Interventions
AZD6244 + Dacarbazine
Group IV: 1Experimental Treatment2 Interventions
AZD6244 + docetaxel
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temsirolimus
2008
Completed Phase 2
~1940
AZD6244
2011
Completed Phase 2
~1570
Dacarbazine
2005
Completed Phase 3
~5110
Erlotinib
2011
Completed Phase 4
~2290
Docetaxel
1995
Completed Phase 4
~5620

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,245 Previous Clinical Trials
288,529,206 Total Patients Enrolled
Jeffrey Infante, MDPrincipal InvestigatorSCRI Development Innovations, LLC
3 Previous Clinical Trials
103 Total Patients Enrolled
Kevin Kim, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
63 Total Patients Enrolled

Media Library

AZD6244 (MEK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00600496 — Phase 1
Kidney Cancer Research Study Groups: 1, 2, 3, 4
Kidney Cancer Clinical Trial 2023: AZD6244 Highlights & Side Effects. Trial Name: NCT00600496 — Phase 1
AZD6244 (MEK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00600496 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many distinct venues is the clinical testing available in?

"Currently, 4 medical sites are actively running this trial. They can be found in Nashville, Detroit and Houston with an additional four other locations available. To reduce any necessary travel arrangements, it is advised to select the site closest to you if one decides to participate."

Answered by AI

What criteria must a person meet to be considered for enrolment into this experiment?

"To be considered for this trial, applicants ought to have malignant colorectal tumors and span the age range of 18-130. A maximum of 140 people will ultimately be selected."

Answered by AI

What therapeutic purposes is AZD6244 typically employed for?

"AZD6244 has been developed to treat metastatic bladder cancer, as well as various other diseases such as advance directives, small cell lung cancer (SCLC), lymphoma, and Hodgkins."

Answered by AI

Is the age criterion for this experiment limited to those younger than 25 years?

"As stated in the inclusion criteria for this clinical trial, participants must be aged between 18 and 130."

Answered by AI

How hazardous is AZD6244 for patients who take it?

"AZD6244 has not yet been extensively tested, so its safety rating was set at 1 on our risk scale. This is a Phase 1 trial which implies that there is limited data available to support both efficacy and security."

Answered by AI

What further exploration has been conducted regarding AZD6244?

"Presently, there are 147 phase 3 clinical trials being conducted for AZD6244 in 440 active studies. Of these sites, the majority of them can be found in Fuzhou, Fujian Province; however, 30211 centers across the world have been enlisted to partake within this research endeavour."

Answered by AI

What is the maximal number of participants being enrolled in this trial?

"Unfortunately, enrollment for this trial has been closed. This clinical study was originally posted on December 14th 2007 and the most recent update was made September 20st 2022. If you are seeking other trials to enroll in, there are 6280 studies involving colon neoplasms with participants being recruited and 440 trials recruiting patients taking AZD6244."

Answered by AI

Are there any current opportunities to enroll in this investigation?

"Per the clinicaltrials.gov registry, this trial is no longer recruiting new participants; it was initially posted on December 14th 2007 and its most recent update came in September 20th 2022. Despite that, over 6720 other medical studies are currently open for enrollment."

Answered by AI
Recent research and studies
~8 spots leftby Apr 2025