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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 15 and 22: pre-dose (within 10 minutes of dosing); 1, 2, and 4 hours post-dose
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the effects of a new drug called AZD6244 on patients with advanced cancer. They will be testing to see if the drug is safe and tolerable for patients.
Who is the study for?
This trial is for adults with advanced solid tumors that haven't responded to standard treatments. Participants should be relatively active and mobile (WHO performance status 0-2), not pregnant, and must not have had recent chemotherapy or radiotherapy. Those with severe diseases or brain complications are excluded.
What is being tested?
The study is testing the safety and how the body processes a capsule form of AZD6244, a potential new cancer treatment. It's aimed at patients whose cancers have stopped responding to usual treatments.
What are the potential side effects?
While specific side effects aren't listed here, common ones for cancer drugs like AZD6244 may include nausea, vomiting, diarrhea, skin rash, fatigue, liver enzyme changes, and blood count fluctuations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 8: pre-dose (within 10 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, and 12 hours post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 8: pre-dose (within 10 minutes of dosing); 5, 15, and 30 minutes, 1, 1.5, 2, 4, 8, and 12 hours post-dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Part A and Part B
Number of Participants With Abnormal Echocardiogram (ECHO) Parameters Reported as TEAEs in Part A and Part B
Number of Participants With Abnormal Electrocardiogram (ECG) Parameters Reported as TEAEs in Part A and Part B
+2 moreSecondary study objectives
AUC of AZD6244 (Part B Single Dose)
AUC of N-desmethyl AZD6244 (Part A)
AUC of N-desmethyl AZD6244 (Part B Single Dose)
+41 moreSide effects data
From 2020 Phase 2 trial • 334 Patients • NCT0124824750%
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%
Lung infection
5%
Dry mouth
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
6Treatment groups
Experimental Treatment
Group I: Part B: Relative Bioavailability (Sequence 2) and Safety Assessment PhaseExperimental Treatment1 Intervention
Participants in relative bioavailability phase will receive a single oral dose of AZD6244 75 mg capsule on Day 1. Following a washout period of 7 days, participants will receive a single oral dose of AZD6244 100 mg free-base suspension (mix and drink) on Day 8 (Sequence 2). In the safety assessment phase, participants who will participate in the relative bioavailability phase will receive oral AZD6244 75 mg capsule bd dosing from Day 9 onwards until disease progression or another protocol-defined discontinuation criterion will be met, whichever will occur first.
Group II: Part B: Relative Bioavailability (Sequence 1) and Safety Assessment PhaseExperimental Treatment1 Intervention
Participants in relative bioavailability phase will receive a single oral dose of AZD6244 100 mg free-base suspension (mix and drink) on Day 1. Following a washout period of 7 days, participants will receive a single oral dose of AZD6244 75 mg capsule on Day 8 (Sequence 1). In the safety assessment phase, participants who will participate in the relative bioavailability phase will receive oral AZD6244 75 mg capsule bd dosing from Day 9 onwards until disease progression or another protocol-defined discontinuation criterion will be met, whichever will occur first.
Group III: Part A: Dose Escalation AZD6244 75 mgExperimental Treatment1 Intervention
Participants will receive a single oral dose of AZD6244 75 mg capsule on Day 1 followed by continuous dosing from Day 2 onwards, until disease progression or another protocol-defined discontinuation criterion will be met, whichever will occur first.
Group IV: Part A: Dose Escalation AZD6244 50 mgExperimental Treatment1 Intervention
Participants will receive a single oral dose of AZD6244 50 mg capsule on Day 1 followed by continuous dosing from Day 2 onwards, until disease progression or another protocol-defined discontinuation criterion will be met, whichever will occur first.
Group V: Part A: Dose Escalation AZD6244 25 mgExperimental Treatment1 Intervention
Participants will receive a single oral dose of AZD6244 25 mg capsule on Day 1 followed by continuous twice daily (bd) dosing from Day 2 onwards, until disease progression or another protocol-defined discontinuation criterion will be met, whichever will occur first.
Group VI: Part A: Dose Escalation AZD6244 100 mgExperimental Treatment1 Intervention
Participants will receive a single oral dose of AZD6244 100 mg capsule on Day 1 followed by continuous dosing from Day 2 onwards, until disease progression or another protocol-defined discontinuation criterion will be met, whichever will occur first.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD6244
2011
Completed Phase 2
~2220
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,403 Previous Clinical Trials
289,125,022 Total Patients Enrolled
Emerging Oncology Medical Science Director, MDStudy DirectorAstraZeneca
4 Previous Clinical Trials
284 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken part in another clinical trial with an experimental drug in the last 30 days.You have received radiation or chemotherapy treatment within the last 21 days.You have a severe and uncontrolled disease that affects your whole body.You have cancer that has spread to your brain or spinal cord, unless it is not causing any symptoms and you are not taking steroids or anticonvulsants.Your cancer has not responded to standard treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Part A: Dose Escalation AZD6244 25 mg
- Group 2: Part A: Dose Escalation AZD6244 50 mg
- Group 3: Part B: Relative Bioavailability (Sequence 2) and Safety Assessment Phase
- Group 4: Part A: Dose Escalation AZD6244 75 mg
- Group 5: Part A: Dose Escalation AZD6244 100 mg
- Group 6: Part B: Relative Bioavailability (Sequence 1) and Safety Assessment Phase
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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