Personalized Medicine Approaches for Cancer

Overseen by Lara Davis

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: OHSU Knight Cancer Institute

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests if analyzing a patient's cancer can help find the best drugs or drug combinations to treat their disease. It targets patients with advanced cancers that are difficult to treat with standard methods. By studying the cancer cells closely, doctors can choose the best treatment options for each patient.

Research Team

Lara Davis

Principal Investigator

OHSU Knight Cancer Institute

Eligibility Criteria

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.

Inclusion Criteria

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.

Exclusion Criteria

Uncontrolled intercurrent illness and infection that may interfere with planned treatment

Severe infection within < four weeks prior to initiation of study treatment

History of allergy to an assigned study agent or its excipients

Treatment Details

Interventions

• Ado-Trastuzumab Emtansine (HER2 Inhibitor)
• Alectinib (ALK Inhibitor)
• Alpelisib (PI3K Inhibitor)
• Anastrozole (Aromatase Inhibitor)
• Atezolizumab (PD-L1 Inhibitor)
• Bevacizumab (VEGF Inhibitor)
• Biopsy (Procedure)
• Biospecimen Collection (Procedure)
• Capecitabine (Antimetabolite)
• Carboplatin (Alkylating Agent)
• Cobimetinib (MEK Inhibitor)
• Entrectinib (ROS1 Inhibitor)
• Eribulin (Microtubule Inhibitor)
• Fulvestrant (Estrogen Receptor Antagonist)
• Hyaluronidase-zzxf/Pertuzumab/Trastuzumab (Monoclonal Antibodies)
• Irinotecan (Topoisomerase I Inhibitor)
• Letrozole (Aromatase Inhibitor)
• Nab-paclitaxel (Taxane)
• Niraparib (PARP Inhibitor)
• Olaparib (PARP Inhibitor)
• Paclitaxel (Taxane)
• Palbociclib (CDK4/6 Inhibitor)
• Vemurafenib (BRAF Inhibitor)
• Vinorelbine (Vinca Alkaloid)
• Vismodegib (Hedgehog Pathway Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Treatment (SMMART-ACT) Experimental Treatment 28 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.

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials

239

Recruited

2,089,000+

Dr. Shivaani Kummar

OHSU Knight Cancer Institute

Chief Executive Officer

MD, FACP

Dr. Gordon Mills

OHSU Knight Cancer Institute

Chief Medical Officer since 2022

MD, PhD

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

John Hunter

Oregon Health and Science University

Chief Medical Officer since 2024

MD, specific details unavailable

Ann Madden Rice

Oregon Health and Science University

Chief Executive Officer

FACHE certification, extensive leadership experience in academic health centers