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HER2 Inhibitor
Personalized Medicine Approaches for Cancer
Phase < 1
Waitlist Available
Led By Lara Davis, M.D.
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time of first dose of study drug until death from any cause (until the end of long-term follow-up), ltfu is up to 5 years
Awards & highlights
Study Summary
This trial is testing if cancer samples can be used to find drugs to control the disease. They will also study the safety and if the drugs have any side effects. Researchers will also study tumor cells to see why some people respond to certain therapies and why some drugs stop working.
Who is the study for?
This trial is for adults with advanced breast, ovarian, prostate, or pancreatic cancer, or sarcomas who have a life expectancy of at least 6 months. They must have measurable lesions after treatment and documented progression after prior therapy. Participants need normal organ function tests and should not be pregnant or breastfeeding. Those with brain metastases, severe infections, other active cancers that could affect the study's outcome are excluded.Check my eligibility
What is being tested?
The SMMART-ACT trial aims to see if precision medicine can find effective drug combinations based on individual cancer samples. It includes testing various drugs like Palbociclib and Trastuzumab among others for safety and effectiveness in controlling disease while also studying why treatments work differently across individuals.See study design
What are the potential side effects?
Potential side effects may include reactions to specific drugs such as fatigue, nausea, blood count changes depending on the intervention used. Since multiple drugs are being tested each participant might experience different side effects based on their personalized treatment regimen.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the time of first dose of study drug until death from any cause (until the end of long-term follow-up), ltfu is up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time of first dose of study drug until death from any cause (until the end of long-term follow-up), ltfu is 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
Proportion of participants who receive an ACT therapy based an ACT Tumor Board recommendation.
Secondary outcome measures
Disease-specific survival
Incidence of treatment-emergent adverse events
Overall response rate (ORR)
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (SMMART-ACT)Experimental Treatment28 Interventions
Administered in monotherapy or in combination with other targeted agents or immunotherapies, chemotherapies, or radiation. Combination treatment plans may include a two-week monotherapy lead-in, followed by a combination treatment regimen. Each ACT study intervention must have an established RP2D determined in a prior clinical trial. Participants undergo a Pre-Treatment Biopsy, plus an On-Treatment Biopsy after two weeks on first dose of study drug(s) and prior to starting Cycle 2, regardless of regimen. Participants continue to receive study agent(s) after the On-Treatment Biopsy, according to the biopsy results and the results of ongoing safety and clinical assessments. Treatment cycles repeat every 21 to 28 days in the absence of disease progression or unacceptable toxicity. Cycles are determined based on the study agent(s). Upon disease progression, participants are given the option to undergo an additional biopsy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vemurafenib
2015
Completed Phase 3
~3100
Trastuzumab
2014
Completed Phase 4
~5190
Pertuzumab
2014
Completed Phase 3
~7500
Paclitaxel
2011
Completed Phase 4
~5380
Niraparib
2018
Completed Phase 4
~1540
Olaparib
2007
Completed Phase 4
~2140
Palbociclib
2017
Completed Phase 3
~3760
Fulvestrant
2011
Completed Phase 3
~3690
Letrozole
2002
Completed Phase 4
~3240
Nab-paclitaxel
2014
Completed Phase 3
~2030
Trastuzumab Emtansine
2016
Completed Phase 3
~5630
Alectinib
2015
Completed Phase 3
~2400
Alpelisib
2018
Completed Phase 3
~900
Anastrozole
2019
Completed Phase 4
~10090
Atezolizumab
2017
Completed Phase 3
~5860
Bevacizumab
2013
Completed Phase 4
~5280
Biopsy
2014
Completed Phase 4
~850
Biospecimen Collection
2004
Completed Phase 2
~1730
Capecitabine
2013
Completed Phase 3
~3420
Irinotecan
2017
Completed Phase 4
~2680
Carboplatin
2014
Completed Phase 3
~6670
Cobimetinib
2017
Completed Phase 3
~2660
Entrectinib
2014
Completed Phase 2
~360
Eribulin
2012
Completed Phase 3
~2700
Vinorelbine
2013
Completed Phase 4
~2190
Vismodegib
2015
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
OHSU Knight Cancer InstituteLead Sponsor
230 Previous Clinical Trials
2,090,726 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,689 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
973 Previous Clinical Trials
6,846,029 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not able or willing to take medicine by mouth.A doctor believes you will likely live for at least 6 more months.Your blood clotting time is not too fast, unless you are already taking medication to slow it down.You have advanced stage of sarcoma, prostate, breast, ovarian, or pancreatic cancer.You have cancer that has spread to your brain or central nervous system, and it has gotten worse.Your liver enzymes, AST and ALT, should not be more than three times the upper limit of normal.Your breast cancer has not responded to other treatments and the tumor can still be measured.You currently have another type of cancer that could interfere with the study.You are in jail or have been detained for psychiatric or physical treatment against your will.You have shown that the disease has worsened after trying at least one treatment before.Your platelet count is at least 100,000 per microliter.Your hemoglobin level is at least 9 g/dL (or 5.6 mmol/L).Your kidney function is normal, and your creatinine levels are within the acceptable range.You must have received a specific treatment recommendation from the SMMART-ACT Tumor Board based on the review of your biopsy results.Your white blood cell count is at least 1500 per microliter.Your activated partial thromboplastin time (aPTT) test result is within a certain range.Your body mass index (BMI) is between 16 and 35.You must also meet the specific requirements for the treatment being studied.You have new, active cancer spreading to your brain or central nervous system, or known cancer in the covering of your brain and spinal cord.You have hepatitis C and have not received treatment for it yet.You are able to perform daily activities without help or needing to stay in bed for more than half of the day.Your total bilirubin level should be no higher than 1.5 times the upper limit of normal. If your total bilirubin level is higher than 1.5 times the upper limit of normal, your direct bilirubin level should be within the normal range.You finished receiving radiation therapy for a specific disease area at least two weeks before starting the SMMART-ACT treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (SMMART-ACT)
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.
Has the SMMART-ACT treatment gained FDA approval?
"There is data indicating that Treatment (SMMART-ACT) may be safe, but not yet any evidence to support its efficacy. For this reason, it was given a score of 2."
Answered by AI
Can people sign up for this experiment right now?
"The trial in question is not currently looking for new patients, however this may change in the future as the study was most recently updated on July 12th, 2022. There are 7285 other clinical trials that are actively recruiting patients at this time."
Answered by AI
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