What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, particularly those tailored to individual tumor characteristics, include chemotherapy agents like gemcitabine and nab-paclitaxel, as well as targeted therapies such as PARP inhibitors. The known side effects of these treatments can vary but often include nausea, fatigue, diarrhea, and myelosuppression (a decrease in bone marrow activity leading to fewer blood cells). Specific side effects for gemcitabine may include flu-like symptoms and rash, while nab-paclitaxel can cause neuropathy (nerve damage). PARP inhibitors, used in patients with specific genetic mutations, may lead to anemia, nausea, and increased risk of infections.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer that align with the precision medicine approach. Olaparib, a PARP inhibitor, has shown efficacy in patients with metastatic pancreatic cancer harboring BRCA1/2 mutations. Additionally, combination regimens such as FOLFIRINOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan) and gemcitabine plus nab-paclitaxel have been approved for their ability to improve survival in advanced pancreatic cancer. These treatments highlight the importance of genomic testing and personalized therapy in managing pancreatic cancer.

What other types of research exist?

Promising novel alternatives to the Precision Medicine Approach for pancreatic cancer patients include new drug combinations emerging from ongoing research, such as those highlighted in the MPACT trial and FOLFIRINOX regimen. These combinations are continually being evaluated for their efficacy and may offer new treatment options in 2024.

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HER2 Inhibitor

Personalized Medicine Approaches for Cancer

Q: What is the mechanism of action of this treatment?

The precision medicine approach for treating pancreatic cancer involves tailoring treatments based on the genetic and molecular profile of the tumor. Common treatments include chemotherapy, which kills rapidly dividing cancer cells by interfering with DNA replication; targeted therapies, such as PARP inhibitors, which exploit defective DNA repair mechanisms in tumors with specific genetic mutations like BRCA1/2; and immunotherapy, which enhances the immune system's ability to recognize and attack cancer cells. This approach is crucial for pancreatic cancer patients as it can lead to more effective and personalized treatment plans, improving outcomes and minimizing side effects.

Phase < 1

Waitlist Available

Led By Lara 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

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

No Placebo-Only Group

Summary

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.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 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 ACT therapy based an ACT Tumor Board recommendation.

Secondary study objectives

Disease-specific survival

Incidence of treatment-emergent adverse events

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

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

Entrectinib

2014

Completed Phase 2

~360

Vemurafenib

2015

Completed Phase 3

~3550

Olaparib

2007

Completed Phase 4

~2190

Trastuzumab Emtansine

2016

Completed Phase 3

~5730

Vinorelbine

2013

Completed Phase 4

~2190

Cobimetinib

2017

Completed Phase 3

~3300

Paclitaxel

2011

Completed Phase 4

~5810

Alpelisib

2018

Completed Phase 3

~960

Capecitabine

2013

Completed Phase 3

~3970

Eribulin

2012

Completed Phase 3

~2740

Vismodegib

2015

Completed Phase 4

~1880

Nab-paclitaxel

2014

Completed Phase 3

~1950

Atezolizumab

2017

Completed Phase 3

~5850

Bevacizumab

2013

Completed Phase 4

~5540

Fulvestrant

2011

Completed Phase 3

~3890

Pertuzumab

2014

Completed Phase 3

~7500

Trastuzumab

2014

Completed Phase 4

~5190

Anastrozole

2016

Completed Phase 4

~5550

Biopsy

2014

Completed Phase 4

~1090

Biospecimen Collection

2004

Completed Phase 3

~2020

Alectinib

2019

Completed Phase 3

~2810

Carboplatin

2014

Completed Phase 3

~6120

Irinotecan

2017

Completed Phase 3

~2590

Letrozole

2002

Completed Phase 4

~3590

Niraparib

2018

Completed Phase 4

~2400

Palbociclib

2017

Completed Phase 3

~3880

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The precision medicine approach for treating pancreatic cancer involves tailoring treatments based on the genetic and molecular profile of the tumor. Common treatments include chemotherapy, which kills rapidly dividing cancer cells by interfering with DNA replication; targeted therapies, such as PARP inhibitors, which exploit defective DNA repair mechanisms in tumors with specific genetic mutations like BRCA1/2; and immunotherapy, which enhances the immune system's ability to recognize and attack cancer cells. This approach is crucial for pancreatic cancer patients as it can lead to more effective and personalized treatment plans, improving outcomes and minimizing side effects.

Molecular biomarkers: their increasing role in the diagnosis, characterization, and therapy guidance in pancreatic cancer.