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Targeted Therapy Based on Genetic Profile for Cancer
N/A
Waitlist Available
Led By Apostolia M Tsimberidou
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The patient has Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase levels (SGPT) =< 2.5 X ULN (unless the patient has liver metastases)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up continuous monitoring, expected range from 2 months to 3 years
Awards & highlights
Study Summary
This trial is testing whether targeted therapy based on a tumor's genetic profile is more effective than standard treatment for metastatic cancer.
Who is the study for?
This trial is for patients with metastatic cancer who have tried standard treatments or decided not to use them. They should be relatively healthy, able to perform daily activities (ECOG 0-1), and have tumors that can be measured or biopsied. Women of childbearing age and men must agree to contraception during the study. Patients with stable brain metastasis off steroids for two weeks are eligible.Check my eligibility
What is being tested?
The trial compares targeted therapy chosen based on genetic differences in a patient's tumor against standard cancer treatment. It aims to determine if personalized medicine, using information about the tumor's molecular profile, is more effective than traditional approaches not tailored to genetic changes.See study design
What are the potential side effects?
Potential side effects depend on the specific targeted therapies used but may include allergic reactions, fatigue, nausea, liver issues, blood cell count changes affecting immunity and clotting, kidney function alterations, and potential interference with normal bowel absorption.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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My liver enzyme levels are normal or slightly elevated.
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My kidneys are functioning well, with a creatinine clearance of at least 50 ml/min.
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My cancer has spread to other parts of my body.
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My brain metastasis is stable, and I haven't taken steroids for 2 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ continuous monitoring, expected range from 2 months to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~continuous monitoring, expected range from 2 months to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Comparison of Progression-Free Survival (PFS) Between the Two Randomized Arms
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B: Standard-of-Care TherapyExperimental Treatment1 Intervention
Standard-of-Care treatment not selected on basis of alteration analysis.
Group II: Arm A: Targeted TherapyActive Control1 Intervention
Personalized treatment, targeted therapy against the alteration based on molecular profiling.
Find a Location
Who is running the clinical trial?
Tempus AIIndustry Sponsor
16 Previous Clinical Trials
16,213 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,797,087 Total Patients Enrolled
Tempus LabsIndustry Sponsor
16 Previous Clinical Trials
16,713 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My tumor can be biopsied or I have a recent tumor sample available.I had cancer before, but I've been cancer-free for over 3 years.I have not been treated based on genetic testing results.I haven't had cancer treatment in the last 3 weeks, or I've recovered from its side effects.I have moderate to severe numbness, tingling, or pain in my hands or feet.My liver enzyme levels are normal or slightly elevated.I have had skin basal cell carcinoma or early-stage cervical cancer.I am a woman who can have children and agree to use birth control during the study.I agree to use contraception or practice abstinence during and for 3 months after the study.I have heart problems like high blood pressure, irregular heartbeat, or recent heart attack.I have had multiple treatments for my condition.I have tried or considered all standard treatments for my metastatic disease.I do not have any severe illnesses like uncontrolled diabetes or severe infections that could affect my participation in the study.I cannot swallow pills due to a physical condition.I am fully active or restricted in physically strenuous activity but can do light work.My kidneys are functioning well, with a creatinine clearance of at least 50 ml/min.My cancer can be measured by tests or scans.I have severe nausea, vomiting, or a chronic gut condition that affects medication absorption.My cancer has spread to other parts of my body.My brain metastasis is stable, and I haven't taken steroids for 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B: Standard-of-Care Therapy
- Group 2: Arm A: Targeted Therapy
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment available for this clinical investigation?
"Affirmative. Information on clinicaltrials.gov states that this study is still open to participants, having first been posted in May 13th of 2014 and most recently modified on September 27th 2022. The trial needs 1 location for the enrollment of a total of 1362 patients."
Answered by AI
What is the participant count of this clinical research?
"Correct. Data hosted on clinicaltrials.gov affirms that this investigation, which was initialised on 13th May 2014, is currently recruiting patients. A total of 1 centre requires the enrollment of approximately 1362 individuals."
Answered by AI
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