WithdrawnEarly Phase 1

SMMART Adaptive Clinical Treatment (ACT) Trial

Stopped: Withdrawn due to a change in therapeutic interventions.

0Started 2023-01-30

Plain-language summary

SMMART-ACT is a feasibility pilot study to determine if testing samples from a participant's cancer using a precision medicine approach can be used to identify specific drugs or drug combinations that can help control their disease. The safety and tolerability of the drug or drug combination is also to be studied. Another purpose is for researchers to study tumor cells to try to learn why some people respond to a certain therapy and others do not, and why some cancer drugs stop working. The study population will include participants with advanced breast, ovarian, prostate, or pancreatic malignancies, or sarcomas.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * PRE-SCREENING: Written informed consent prior to any pre-screening activities, study-specific procedures or interventions. * PRE-SCREENING: At least 18 years of age at time of informed consent. Persons of all gender identities, biological sexes, races, and ethnicities will be included. * PRE-SCREENING: A diagnosis of advanced sarcoma or advanced prostate, breast, ovarian, or pancreatic cancer. Change in an individual's cancer can be tracked objectively according to the Prostate Cancer Working Group 3 (PCWG3) criteria for prostate cancer, and Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria for sarcomas and breast, ovarian, and pancreatic cancers. * PRE-SCREENING: Biospecimen collection, as per institutional standards, must be consented to and collection must be feasible, with the following exceptions for tissue collections: * Individuals with a prior successful SMMART-CAP tumor tissue sample collected within the last 90 days may be eligible, given that =\<1 treatment has been received within =\< 90 days of that biopsy. * PRE-SCREENING: Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2. * PRE-SCREENING: Physician assessed life expectancy of \>= 6 months. * PRIMARY TREATMENT: Documented progression after at least 1 line of prior therapy for advanced disease. If recurrence occurred within 6 months of the last dose of an adjuvant/neoadjuvant therapy, that adjuvant/neoadjuvant therapy will count as 1 line…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of participants who receive an ACT therapy based an ACT Tumor Board recommendation.

Timeframe: From time of SMMART-ACT Tumor Board review to first dose of SMMART-ACT study drug regime as evaluated at interim analysis (approximately 2 years)

Trial details

NCT IDNCT05238831

SponsorOHSU Knight Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-31

View on ClinicalTrials.gov More Advanced Breast Carcinoma trials