Precision Medicine Approach for Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Lara Davis, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: OHSU Knight Cancer Institute

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial tests the how well a precision medicine approach (serial measurements of molecular and architectural response to therapy \[SMMART\])-adaptive clinical treatment \[ACT\]) works in treating patients with sarcoma, prostate, breast, ovarian or pancreatic cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). SMMART testing uses genetic and protein tests to learn how cancer changes and to understand what drugs may work against a person's cancer or why drugs stop working. These test results are reviewed by a group of physicians and scientists during a SMMART tumor board who then recommend precision therapy.

Eligibility Criteria

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.

Inclusion Criteria

I can do most of my daily activities by myself.

Consented biospecimen collection as per institutional standards, with exceptions for prior successful SMMART-CAP assays

Physician-assessed life expectancy of ≥ 6 months

Exclusion Criteria

I am not on any cancer treatments that could affect the trial's safety or results.

I cannot or will not take pills for the study.

History of allergy to an assigned study agent or its excipients

Participant Groups

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.

Group I: Arm XIV (osimertinib) Experimental Treatment 7 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 Treatment 8 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 Treatment 7 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 Treatment 5 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 Treatment 5 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 Treatment 6 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 Treatment 7 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 Treatment 6 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 Treatment 6 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 Treatment 4 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 Treatment 6 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 Treatment 5 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 Treatment 6 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 Treatment 6 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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

OHSU Knight Cancer Institute-Northwest Portland Portland, OR

OHSU Knight Cancer Institute Portland, OR

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute Lead Sponsor

Oregon Health and Science University Collaborator

AstraZeneca Industry Sponsor

Eli Lilly and Company Industry Sponsor

References