Precision Medicine Approach for Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, it mentions that concurrent forms of anti-cancer therapy that might interfere with the study are not allowed, except for some hormone therapies. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the treatment SMMART-ACT in the Precision Medicine Approach for Cancer?
Precision medicine in cancer care uses detailed information about a person's tumor to tailor treatments, which can improve effectiveness and reduce side effects. Research shows that using targeted therapies based on molecular profiling can lead to better outcomes, as seen in some small clinical trials and ongoing studies.12345
What safety data exists for the precision medicine approach for cancer treatment?
Research on small molecule kinase inhibitors (a type of cancer treatment) has shown that they can have various adverse events (unwanted side effects) in patients. A machine-learning model has been developed to predict these side effects, helping to identify and manage potential safety risks for individual patients.678910
How is the SMMART-ACT treatment different from other cancer treatments?
SMMART-ACT is unique because it uses a precision medicine approach, which involves analyzing the genetic makeup of a patient's tumor to tailor treatments specifically to their cancer's molecular profile. This method aims to improve treatment effectiveness and reduce side effects by targeting the specific genetic alterations present in the tumor, rather than using a one-size-fits-all approach.211121314
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.
Research Team
Lara Davis, MD
Principal Investigator
OHSU Knight Cancer Institute
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive personalized advanced cancer treatment based on SMMART-ACT tumor board recommendations. Treatment involves various drug regimens across 14 arms, with cycles repeating every 21 or 28 days for up to 6-8 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up includes regular assessments every 3 months for 1 year, then every 6 months until year 5.
Treatment Details
Interventions
- SMMART-ACT
Find a Clinic Near You
Who Is Running the Clinical Trial?
OHSU Knight Cancer Institute
Lead Sponsor
Oregon Health and Science University
Collaborator
AstraZeneca
Industry Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University