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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 weeks3 visits

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

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 Treatment7 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. Additionally, prostate cancer patients undergo bone scan on study.

Group II: Arm XIII (olaparib, liposomal doxorubicin)Experimental Treatment8 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. Additionally, prostate cancer patients undergo bone scan on study.

Group III: Arm XII (olaparib, carboplatin, paclitaxel)Experimental Treatment7 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. Additionally, prostate cancer patients undergo bone scan on study.

Group IV: Arm XI (olaparib)Experimental Treatment5 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. Additionally, prostate cancer patients undergo bone scan on study.

Group V: Arm X (gefitinib)Experimental Treatment5 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. Additionally, prostate cancer patients undergo bone scan on study.

Group VI: Arm VIII (olaparib, temozolomide)Experimental Treatment6 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. Additionally, prostate cancer patients undergo bone scan on study.

Group VII: Arm VII (gefitinib, pemetrexed, carboplatin)Experimental Treatment7 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. Additionally, prostate cancer patients undergo bone scan on study.

Group VIII: Arm VI (abemaciclib, tamoxifen)Experimental Treatment6 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. Additionally, prostate cancer patients undergo bone scan on study.

Group IX: Arm V (abemaciclib, letrozole)Experimental Treatment6 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. Additionally, prostate cancer patients undergo bone scan on study.

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. Additionally, prostate cancer patients undergo bone scan on study.

Group XI: Arm IV (abemaciclib, exemestane)Experimental Treatment6 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. Additionally, prostate cancer patients undergo bone scan on study.

Group XII: Arm III (abemaciclib)Experimental Treatment5 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. Additionally, prostate cancer patients undergo bone scan on study.

Group XIII: Arm II (abemaciclib, pemetrexed)Experimental Treatment6 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. Additionally, prostate cancer patients undergo bone scan on study.

Group XIV: Arm I (abemaciclib, gemcitabine)Experimental Treatment6 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. Additionally, prostate cancer patients undergo bone scan on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~1920

Bone Scan

2015

Completed Phase 2

~50