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Tyrosine Kinase Inhibitor
AMG 706 + Gemcitabine for Cancer
Phase 1
Waitlist Available
Led By Carolyn Britten, MD
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status 0-2
Able to swallow oral medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing the effects of a new drug, AMG 706, when given with gemcitabine to patients with advanced solid tumors or lymphoma. The purpose is to study the side effects and what dose is best.
Who is the study for?
This trial is for patients with advanced solid tumors or lymphoma who can take gemcitabine, have measurable disease, and are in fair to good health (ECOG 0-2). They must be able to swallow pills. Excluded are those with certain heart diseases, recent thrombosis, HIV, untreated brain metastases, pregnancy or nursing mothers.Check my eligibility
What is being tested?
The study tests the combination of AMG 706 and gemcitabine chemotherapy to see how well they work together against cancer by blocking blood flow to tumors and stopping cell growth. It aims to find the best dose with acceptable side effects.See study design
What are the potential side effects?
Potential side effects include issues related to heart function due to AMG 706's effect on blood vessels; typical chemotherapy-related symptoms like nausea from gemcitabine; as well as general risks such as fatigue and infection susceptibility.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and perform daily activities.
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I can take pills by mouth.
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My cancer diagnosis was confirmed through tissue or cell testing.
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My cancer can be measured and is either outside of areas previously treated with radiation or has grown back in those areas.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose-limiting toxicity as assessed by NCI CTCAE v3.0
Maximum tolerated dose as assessed by NCI CTCAE v3.0
Secondary outcome measures
Biomarkers as measured by RNA transcript profiling and/or proteomic methods at weeks 1, 2, 4, 9, 13, 21, 29, 37, 45, 49
Incidence of adverse events, serious adverse events, and laboratory abnormalities not defined as dose-limiting toxicities as assessed by NCI CTCAE v3.0
Pharmacokinetic profiles as measured by blood sampling at weeks 1, 2, 9, 13, 21, 29, 37, 45, and 49
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Who is running the clinical trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
26,057 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,135 Total Patients Enrolled
Carolyn Britten, MDPrincipal InvestigatorJonsson Comprehensive Cancer Center
6 Previous Clinical Trials
104 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have brain metastases that are either untreated or causing symptoms.I have not taken drugs targeting the kinase insert domain receptor.I have severe heart disease.I am currently taking interferon.I can take care of myself and perform daily activities.I have not had a blood clot in my arteries or veins in the past year.I can take pills by mouth.My doctor thinks I should get gemcitabine treatment.I am HIV positive.My cancer has spread to my intestines.I have had a heart attack in the last year.I have been diagnosed with congestive heart failure.You are currently consuming grapefruit juice or whole grapefruit.I plan to have surgery within 2 weeks after my last dose of AMG 706.My lung cancer is squamous cell type or is a large tumor near the center of my chest.My cancer diagnosis was confirmed through tissue or cell testing.My cancer can be measured and is either outside of areas previously treated with radiation or has grown back in those areas.I have unstable chest pain.My heart condition is stable and does not affect my daily activities.I am not currently undergoing any cancer treatments like chemotherapy or radiotherapy.
Research Study Groups:
This trial has the following groups: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 this research endeavor currently accepting participants?
"According to the information posted on clinicaltrials.gov, this study is not presently recruiting patients. The original post for this trial was made on October 1st 2005 and it has since been updated as recently as September 16th 2013; yet there are no current openings at this time, but 3378 other studies are actively enrolling participants currently."
Answered by AI
Is this treatment modality proven to be innocuous for human use?
"Our assessment of the treatment's safety ranked it a 1 on our scale due to this being an early-stage Phase 1 trial with limited data available for both efficacy and safety."
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