AZD6244 for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Research Site, Philadelphia, PABreast Cancer+6 MoreAZD6244 - Drug
Eligibility
18 - 130
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Breast Cancer
  • Melanoma
  • Colon Cancer
  • Colorectal Cancer
  • Lung Cancer
  • Kidney Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Cycle 1 Day 3 and Cycle 2 day 1

28 days +
Define highest tolerated dose of AZD6244 when in combination with selected chemotherapies.
Safety and tolerability of twice daily oral doses of AZD6244 when administered in combination with standard doses of selected chemotherapies.
Tumor response.
Day 3
Pharmacotherapy

Trial Safety

Safety Progress

1 of 3

Side Effects for

Arm 1 - Erlotinib
50%Rash Acneiform
36%Diarrhea
32%Dry skin
32%Nausea
27%Anorexia
23%Increased blood bilirubin
23%Increased AST
23%Vomiting
14%Other skin and subcutaneous tissue disorders, specify
14%Epistaxis
14%Oral mucositis
14%Weight loss
14%Rash Maculopapular
9%Increased alkaline phosphatase
9%Hyperglycemia
9%Fatigue
5%Multi-organ failure
5%Dry mouth
5%Dyspnea
5%Hyponatremia
5%Pruritus
5%Lung infection
5%Palmar-plantar erythrodysesthesia syndrome
5%Hypoalbuminemia
5%Dysgeusia
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT01248247) in the Arm 1 - Erlotinib ARM group. Side effects include: Rash Acneiform with 50%, Diarrhea with 36%, Dry skin with 32%, Nausea with 32%, Anorexia with 27%.

Trial Design

4 Treatment Groups

1
1 of 4
3
1 of 4
4
1 of 4
2
1 of 4

Experimental Treatment

140 Total Participants · 4 Treatment Groups

Primary Treatment: AZD6244 · No Placebo Group · Phase 1

1Experimental Group · 2 Interventions: Docetaxel, AZD6244 · Intervention Types: Drug, Drug
3Experimental Group · 2 Interventions: AZD6244, Erlotinib · Intervention Types: Drug, Drug
4Experimental Group · 2 Interventions: AZD6244, Temsirolimus · Intervention Types: Drug, Drug
2Experimental Group · 2 Interventions: Dacarbazine, AZD6244 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dacarbazine
FDA approved
Docetaxel
FDA approved
Selumetinib
FDA approved
Temsirolimus
FDA approved
Erlotinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: cycle 1 day 3 and cycle 2 day 1

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,015 Previous Clinical Trials
240,372,718 Total Patients Enrolled
160 Trials studying Breast Cancer
1,236,985 Patients Enrolled for Breast Cancer
Patricia LoRusso, DOPrincipal InvestigatorBarbara Ann Karmanos Cancer Institute
6 Previous Clinical Trials
380 Total Patients Enrolled
Kevin Kim, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
63 Total Patients Enrolled
Jeffrey Infante, MDPrincipal InvestigatorSCRI Development Innovations, LLC
3 Previous Clinical Trials
103 Total Patients Enrolled
Roger Cohen, MDPrincipal InvestigatorFox Chase Cancer Center
4 Previous Clinical Trials
120 Total Patients Enrolled

Eligibility Criteria

Age 18 - 130 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a disease that cannot be cured and the chemotherapy being studied is the standard treatment for your condition.
You must be able to swallow capsules of AZD6244.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.