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Anti-tumor antibiotic, Anti-metabolites, Virus Therapy, Monoclonal Antibodies, Checkpoint Inhibitor, Kinase Inhibitor, Corticosteroid
Personalized Cancer Therapy for Cancer
Phase 1
Waitlist Available
Led By Zahi Mitri, MD, MS
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Creatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) >= 60 mL/min/1.73 m^2 for participants with creatinine levels > 1 x institutional ULN (at time of registration and within 4 weeks prior to initiating on-protocol treatment)
Participants must have Eastern Cooperative Oncology Group (ECOG) performance status =< 2 and a physician assessed life expectancy of >= 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up death from any cause (up to 60 months after the last dose of smmart-prime therapy #1)
Awards & highlights
Study Summary
This trial is to test if cancer drugs can be tailored to the individual, and to understand why drugs stop working.
Who is the study for?
Adults over 21 with various advanced cancers, good performance status (able to carry out daily activities), and a life expectancy of at least 6 months. They must have normal organ function tests, no active infections or other cancers, not be on other experimental drugs, and agree to use contraception.Check my eligibility
What is being tested?
The SMMART PRIME trial is testing how different drug combinations affect individual cancer cases by analyzing patient samples. It aims to understand why treatments fail and how diverse cancers respond to varied therapies.See study design
What are the potential side effects?
Potential side effects depend on the specific drugs used but may include immune reactions, liver or kidney issues, blood clots or bleeding problems due to anticoagulants if used, fatigue, nausea, hair loss except for alopecia patients.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is within the normal range required.
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I can care for myself and am expected to live 6 months or more.
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My cancer is spreading and has been confirmed by tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ death from any cause (up to 60 months after the last dose of smmart-prime therapy #1)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~death from any cause (up to 60 months after the last dose of smmart-prime therapy #1)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of implementing an individualized treatment strategy (number of participants to receive first dose)
Secondary outcome measures
Incidence of grade 3+ toxicities attributable to assigned study drug(s)
Overall survival (OS)
Time to decline (TTD)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (biospecimen collection, 2 drug combination)Experimental Treatment56 Interventions
TUMOR BIOPSY: Patients undergo collection of tissue samples. Clinical analytics are performed on the samples and analyzed by a clinical tumor board to recommend a treatment option based on those analytics.
SMMART-PRIME TREATMENT: Patients receive a combination of 2 drugs (Drug A and Drug B, selected from interventions below). Doses will be escalated within individual patients over time. As described in detail below, escalation will occur monthly and is anticipated to occur as follows: first month - 100% FDA approved dose Drug A + 25% FDA approved dose Drug B; second month -- 100% dose Drug A + 50% dose Drug B; third month -- 100% dose Drug A + 100% dose Drug B. All dose-escalations will be reviewed and approved by an independent consultant outside of Oregon Health & Science University (OHSU).
Treatment will continue for up to the end of 6 treatment cycles (cycle length is between 21-28 days) in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
2020
Completed Phase 2
~1080
Bevacizumab
2013
Completed Phase 4
~5280
Venetoclax
2019
Completed Phase 3
~1990
Cabazitaxel
2014
Completed Phase 3
~1290
Everolimus
2010
Completed Phase 4
~1510
Tretinoin
2013
Completed Phase 4
~2040
Dacomitinib
2019
Completed Phase 4
~580
Enzalutamide
2014
Completed Phase 4
~2760
Pertuzumab
2014
Completed Phase 3
~7500
Nab-paclitaxel
2014
Completed Phase 3
~2030
Ipilimumab
2014
Completed Phase 3
~2620
Oxaliplatin
2011
Completed Phase 4
~2560
Celecoxib
2019
Completed Phase 4
~1740
Copanlisib
2016
Completed Phase 2
~130
Capecitabine
2013
Completed Phase 3
~3420
Regorafenib
2014
Completed Phase 2
~1580
Ruxolitinib
2018
Completed Phase 3
~1140
Lorlatinib
2018
Completed Phase 4
~440
Enasidenib
2020
Completed Phase 2
~560
Palbociclib
2017
Completed Phase 3
~3760
Ponatinib
2015
Completed Phase 2
~820
Trametinib
2014
Completed Phase 2
~1550
Doxorubicin
2012
Completed Phase 3
~7940
Lenvatinib
2005
Completed Phase 4
~2690
Olaparib
2007
Completed Phase 4
~2140
Trastuzumab Emtansine
2016
Completed Phase 3
~5630
Dabrafenib
2011
Completed Phase 3
~4120
Neratinib
2014
Completed Phase 2
~1970
Imatinib
2011
Completed Phase 3
~3940
Abiraterone
2012
Completed Phase 4
~2830
Idelalisib
2017
Completed Phase 3
~1660
Sunitinib
2014
Completed Phase 3
~4380
Fluorouracil
2014
Completed Phase 3
~11540
Dasatinib
2012
Completed Phase 3
~2320
Leucovorin
2005
Completed Phase 4
~5730
Vorinostat
2014
Completed Phase 3
~1600
Nivolumab
2014
Completed Phase 3
~4750
Sirolimus
2013
Completed Phase 4
~2750
Entrectinib
2014
Completed Phase 2
~360
Losartan
2003
Completed Phase 4
~3000
Panobinostat
2011
Completed Phase 3
~1560
Pembrolizumab
2017
Completed Phase 2
~2010
Sorafenib
2014
Completed Phase 3
~1670
Vemurafenib
2015
Completed Phase 3
~3100
Vismodegib
2015
Completed Phase 4
~1880
Abemaciclib
2019
Completed Phase 2
~1710
Bortezomib
2005
Completed Phase 2
~1140
Afatinib
2016
Completed Phase 4
~2340
Cobimetinib
2017
Completed Phase 3
~2660
Carboplatin
2014
Completed Phase 3
~6670
Biospecimen Collection
2004
Completed Phase 2
~1730
Darolutamide
2018
Completed Phase 2
~100
Erlotinib
2011
Completed Phase 4
~2290
Bicalutamide
2003
Completed Phase 3
~5330
Durvalumab
2017
Completed Phase 2
~3870
Find a Location
Who is running the clinical trial?
Oregon Health and Science UniversityOTHER
973 Previous Clinical Trials
6,846,027 Total Patients Enrolled
8 Trials studying Lymphoma
360 Patients Enrolled for Lymphoma
OHSU Knight Cancer InstituteLead Sponsor
230 Previous Clinical Trials
2,090,724 Total Patients Enrolled
20 Trials studying Lymphoma
1,067 Patients Enrolled for Lymphoma
Zahi Mitri, MD, MSPrincipal InvestigatorOHSU Knight Cancer Institute
4 Previous Clinical Trials
143 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any other active cancer besides the one being treated.My condition has worsened and I can't care for myself.You have HIV, hepatitis B, or hepatitis C.My brain or spinal cord cancer has not been controlled or was found in the last 4 weeks.My blood clotting time is normal or managed with medication.Your platelet count is at least 100,000 per microliter within 4 weeks before starting the treatment.My kidney function is within the normal range required.I do not have any untreated infections.Women who could become pregnant must have a negative pregnancy test within 14 days before starting the study drug.I finished any major treatments or surgeries over 4 weeks ago, and any side effects are mild.I have chronic GVHD or am on medication to control GVHD.I can care for myself and am expected to live 6 months or more.You have had an allergic reaction to the study drug or its ingredients while taking it.My cancer is spreading and has been confirmed by tests.Your white blood cell count is at least 1,500 per microliter.I am 21 years old or older.I do not have any serious heart conditions or recent heart attacks.I agree to use birth control during and for 4 months after the study.My blood clotting time is normal or managed if I'm on blood thinners.Your liver enzymes (AST and ALT) are not more than three times the normal level.Your body mass index (BMI) is between 16 and 35 kilograms per square meter.Your hemoglobin level is at least 9 g/dL.Your bilirubin levels must be within a certain range, and if they are too high, you may not be able to participate.You must have a disease that can be measured.You must also meet specific criteria related to your type of cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (biospecimen collection, 2 drug combination)
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.
To what extent is participation in this investigation increasing?
"Affirmative. According to information posted on clinicaltrials.gov, this trial is currently enrolling participants; the protocol was first shared on April 1st 2020 and was recently revised on July 12th 2022. The study requires 40 people from a single medical centre for participation."
Answered by AI
Could you provide a synopsis of any preceding studies that focused on collecting biospecimens and administering two drugs in tandem?
"Currently, there are 5,625 distinct clinical trials dedicated to Treatment (biospecimen collection, 2 drug combination). Of those live studies, 1,098 have advanced to Phase 3. While the majority of these experiments happen in Guangzhou within Guangdong province - 232870 other medical centres also provide this treatment."
Answered by AI
Is this an experimental trial?
"At present, there are 5,625 live studies related to Treatment (biospecimen collection, 2 drug combination) in 6505 cities and 98 countries. The first clinical trial investigating this treatment was sponsored by Alfacell back in 1997 with a sample size of 300 participants that managed to reach Phase 3. Since then 8,565 trials have been successfully concluded."
Answered by AI
Are there currently any vacancies within this research trial?
"Affirmative. According to clinicaltrials.gov, this medical trial is looking for volunteers; the initial posting was on April 1st 2020 and it has been revised as of July 12th 2022. 40 people are needed from one site."
Answered by AI
What conditions can be addressed with the Treatment (biospecimen collection, 2 drug combination) protocol?
"Treatment (biospecimen collection, 2 drug combination) is frequently prescribed to treat malignant melanoma of the skin. It has also proven effective at managing recurrent cervical cancer and leukemia."
Answered by AI
Has the FDA sanctioned the collection of biospecimens and use of a two drug combination for this treatment?
"As this is a Phase 1 trial, with relatively little data concerning safety and efficacy, we can only rate the proposed treatment (biospecimen collection combined with two drugs) as having low security on a scale of one to three."
Answered by AI
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