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Precision Medicine

Precision Medicine Approach for Cancer

Phase 2
Waitlist Available
Led By Lara E Davis
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
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
A diagnosis of advanced sarcoma or advanced prostate, breast, ovarian, or pancreatic cancer with objective tracking criteria
Must not have
Concurrent forms of anti-cancer therapy that may interfere with efficacy and safety assessments
Progressive brain/central nervous system (CNS) metastasis within ≤ four weeks of CNS directed treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of study drug to first date of documented progression or recurrence (recist 1.1), end-of-study, or death due to any cause, whichever occurs first, up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a personalized medicine approach called SMMART-ACT in patients with advanced sarcoma, prostate, breast, ovarian, or pancreatic cancer. The approach involves genetic and protein tests to understand

Who is the study for?
This trial is for patients with advanced sarcoma, prostate, breast, ovarian or pancreatic cancer that has spread. Participants must have a type of cancer that's eligible and be willing to undergo various treatments and tests as part of the precision medicine approach.
What is being tested?
The trial is testing a precision medicine method called SMMART-ACT. It involves genetic and protein tests to tailor treatment based on how the cancer responds. Treatments include drugs like Exemestane, Gefitinib, Gemcitabine, among others.
What are the potential side effects?
Potential side effects depend on the specific drugs used but may include nausea, fatigue, hair loss from chemotherapy agents; hormonal changes from therapies like Tamoxifen; skin reactions from targeted drugs like Gefitinib.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can do most of my daily activities by myself.
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I have advanced sarcoma or cancer of the prostate, breast, ovary, or pancreas.
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My condition worsened after treatment for advanced disease.
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A specialized tumor board has recommended a specific treatment plan for me.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not on any cancer treatments that could affect the trial's safety or results.
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My brain cancer has worsened within 4 weeks after treatment aimed at my brain.
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I have new brain metastases or leptomeningeal disease needing urgent treatment.
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I cannot or will not take pills for the study.
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I do not have another active cancer that could interfere with the study.
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I don't have a tumor that can be biopsied or enough stored tissue samples.
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I've had more than one treatment for cancer after my initial biopsy.
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I have hepatitis C that has not been treated or cured.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study drug to first date of documented progression or recurrence (recist 1.1), end-of-study, or death due to any cause, whichever occurs first, up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug to first date of documented progression or recurrence (recist 1.1), end-of-study, or death due to any cause, whichever occurs first, up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of participants who receive an adaptive clinical treatment (ACT) therapy based serial measurements of molecular and architectural responses to therapy (SMMART)-ACT tumor board recommendation
Secondary study objectives
Disease specific survival (DSS)
Incidence of treatment emergent adverse events (TEAEs) suspected or confirmed as attributed to study therapy
Overall response rate (ORR)
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

14Treatment groups
Experimental Treatment
Group I: Arm XIV (osimertinib)Experimental Treatment6 Interventions
Patients receive osimertinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography or MUGA scan and blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment.
Group II: Arm XIII (olaparib, liposomal doxorubicin)Experimental Treatment7 Interventions
Patients receive olaparib PO BID on days 1-28 and liposomal doxorubicin IV on day 1 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography or MUGA scan and blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment.
Group III: Arm XII (olaparib, carboplatin, paclitaxel)Experimental Treatment6 Interventions
Patients receive olaparib PO BID on days 1-3, 8-10, 15-17, 21-23 and carboplatin IV and paclitaxel IV on days 1, 8 and 15 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study, as clinically indicated, and optionally at the end of treatment.
Group IV: Arm XI (olaparib)Experimental Treatment4 Interventions
Patients receive olaparib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment.
Group V: Arm X (gefitinib)Experimental Treatment4 Interventions
Patients receive gefitinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment.
Group VI: Arm VIII (olaparib, temozolomide)Experimental Treatment5 Interventions
Patients receive olaparib PO BID and temozolomide PO QD on days 1-7 of each cycle. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment.
Group VII: Arm VII (gefitinib, pemetrexed, carboplatin)Experimental Treatment6 Interventions
Patients receive gefitinib PO QD on days 1-21, pemetrexed IV on day 1 of each cycle and carboplatin IV on day 1 of cycles 1-6. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment.
Group VIII: Arm VI (abemaciclib, tamoxifen)Experimental Treatment5 Interventions
Patients receive abemaciclib PO BID and tamoxifen PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment.
Group IX: Arm V (abemaciclib, letrozole)Experimental Treatment5 Interventions
Patients receive abemaciclib PO BID and letrozole PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment.
Group X: Arm IX (fulvestrant)Experimental Treatment4 Interventions
Patients receive fulvestrant IM on days 1, 15 and 29 of cycle 1 and day 1 of subsequent cycles. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment.
Group XI: Arm IV (abemaciclib, exemestane)Experimental Treatment5 Interventions
Patients receive abemaciclib PO BID and exemestane PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment.
Group XII: Arm III (abemaciclib)Experimental Treatment4 Interventions
Patients receive abemaciclib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment.
Group XIII: Arm II (abemaciclib, pemetrexed)Experimental Treatment5 Interventions
Patients receive abemaciclib PO BID on days 1-21 and pemetrexed IV over 10 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment.
Group XIV: Arm I (abemaciclib, gemcitabine)Experimental Treatment5 Interventions
Patients receive abemaciclib PO BID on days 1-21 and gemcitabine IV over 30 minutes on days 1 and 8 of each cycle. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
2017
Completed Phase 4
~1100
Biopsy
2014
Completed Phase 4
~1090
Exemestane
2003
Completed Phase 4
~7510
Gefitinib
2005
Completed Phase 3
~2440
Abemaciclib
2019
Completed Phase 2
~1990
Biospecimen Collection
2004
Completed Phase 3
~2020
Fulvestrant
2011
Completed Phase 3
~3890
Carboplatin
2014
Completed Phase 3
~6120
Temozolomide
2010
Completed Phase 3
~1880
Gemcitabine
2017
Completed Phase 3
~1920
Olaparib
2007
Completed Phase 4
~2190
Echocardiography
2013
Completed Phase 4
~11580
Letrozole
2002
Completed Phase 4
~3590
Multigated Acquisition Scan
2015
Completed Phase 3
~270
Paclitaxel
2011
Completed Phase 4
~5810
Pemetrexed
2014
Completed Phase 3
~5550
Tamoxifen
2005
Completed Phase 4
~30110
Pegylated Liposomal Doxorubicin Hydrochloride
2001
Completed Phase 3
~4520

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityOTHER
1,000 Previous Clinical Trials
7,388,345 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,378 Previous Clinical Trials
288,738,880 Total Patients Enrolled
48 Trials studying Ovarian Cancer
24,022 Patients Enrolled for Ovarian Cancer
Eli Lilly and CompanyIndustry Sponsor
2,657 Previous Clinical Trials
3,224,852 Total Patients Enrolled
25 Trials studying Ovarian Cancer
2,206 Patients Enrolled for Ovarian Cancer
~25 spots leftby Dec 2027
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