Study Stopped
Withdrawn due to a change in therapeutic interventions.
SMMART Adaptive Clinical Treatment (ACT) Trial
Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) Trial: Adaptive Clinical Treatment (ACT)
2 other identifiers
interventional
N/A
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2023
Typical duration for early_phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2022
CompletedFirst Posted
Study publicly available on registry
February 14, 2022
CompletedStudy Start
First participant enrolled
January 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
January 23, 2024
January 1, 2024
3.3 years
February 9, 2022
January 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of participants who receive an ACT therapy based an ACT Tumor Board recommendation.
At interim analysis, if greater than or equal to 11 of the first 15 enrolled participants (80%) receive C1D1 of the recommended ACT drug regimen, the feasibility threshold will be met. If not attained, reasons as to why the feasibility endpoint was not met will be reviewed.
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)
Secondary Outcomes (6)
Incidence of treatment-emergent adverse events
First dose of study drug up to 30 days after last dose study drug(s)
Rate of treatment discontinuation due to toxicities and/or intolerability.
First dose of study drug to last dose study drug(s)
Overall response rate (ORR)
At 6 months from cycle 1 day 1 +/- 2 weeks (each cycle may be 21 or 28 days, depending on the assigned SMMART ACT regimen)
Progression free survival
From the first dose of study drug until the earliest date of disease progression, as measured by investigator assessment, or death due to any cause (until the end of long-term follow-up (LTFU)), LTFU is up to 5 years
Disease-specific survival
Time from the first day of treatment with study intervention to death as a result of the disease at time of last follow-up, LTFU is up to five years from time of last dose of study therapy
- +1 more secondary outcomes
Study Arms (1)
Treatment (SMMART-ACT)
EXPERIMENTALAdministered 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.
Interventions
Given orally (PO)
Given PO
Given PO
Given IV
Given IV
Undergo collection of blood
Given IV
Given PO
Given by injection
Given phesgo SC
Given IV
Given PO
Given IV
Given IV
Given subcutaneously (SC)
Ancillary studies
Given SC
Given intravenously (IV)
Given PO
Given PO
Eligibility Criteria
You may qualify if:
- 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 of therapy.
- PRIMARY TREATMENT: SMMART-ACT Tumor Board treatment recommendation of at least one per protocol ACT intervention based on the board's review of SMMART-CAP results on a pre-screening biopsy.
- PRIMARY TREATMENT: Absolute neutrophil count (ANC) \>= 1,500 / uL (1.5 K/cu mm) (assessed at primary \[post pre-screening\] screening, or by the time that study intervention commences)
- May be waived, per principal investigator (PI), on a case-by-case basis for participant populations recognized to have normal baseline values below this level
- PRIMARY TREATMENT: Platelets \>= 100,000 / uL (100 K/cu mm) (assessed at primary \[post pre-screening\] screening, or by the time that study intervention commences)
- PRIMARY TREATMENT: Hemoglobin \>= 9 g/dL (or \>= 5.6 mmol/L) (assessed at primary \[post pre-screening\] screening, or by the time that study intervention commences)
- PRIMARY TREATMENT: Creatinine =\< 1.5 x institutional upper limit of normal (IULN) OR measured or calculated creatinine clearance (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\]) \>= 50 mL/min/1.73m\^2. (assessed at primary \[post pre-screening\] screening, or by the time that study intervention commences)
- Creatinine clearance should be calculated per institutional standard. For participants with a baseline calculated creatinine clearance below normal institutional laboratory values, a measured baseline creatinine clearance should be determined. Individuals with higher values felt to be consistent with inborn errors of metabolism will be considered on a case-by-case basis.
- +17 more criteria
You may not qualify if:
- PRE-SCREENING: Evidence of active malignancy of another cancer with a natural or treatment history that may affect safety or efficacy assessments of this study or impose unacceptable risk to the participant. Guiding examples for those who can be enrolled include: individuals who have been disease free for two years; cancers with high cure rates (e.g., prior history of stage 1 rectal cancer and currently otherwise disease free); adequately treated localized non-melanomatous skin cancer.
- PRE-SCREENING: Involuntarily incarceration, including, but not limited to, imprisonment and compulsory detained for treatment of psychiatric or physical (e.g., infectious disease) illness.
- PRIMARY TREATMENT: Any brain/central nervous system (CNS) metastases or brain/CNS metastases that has progressed (e.g., evidence of new or enlarging brain metastasis that progresses within =\< four weeks of CNS directed treatment as ascertained by clinical examination(s) and magnetic resonance imaging (MRI) or computed tomography (CT) during the main eligibility screening period.
- PRIMARY TREATMENT: One or more new, active brain/CNS metastasis or the presence of known leptomeningeal disease (LMD) that requires immediate treatment. If treatment within the first cycle of therapy is unlikely to be required, enrollment may be considered, as per the investigator.
- PRIMARY TREATMENT: Concurrent forms of anti-cancer therapy that have the potential to interfere with efficacy and safety assessments or may that may pose increased risk to the participant while on a SMMART-ACT treatment, and as per the investigator. (Select hormone therapies, are allowed.)
- PRIMARY TREATMENT: Uncontrolled intercurrent illness and infection that may interfere with planned treatment including, but not limited to the following:
- Symptomatic congestive heart failure (New York Heart Association \[NYHA\] class III or IV)
- Unstable angina pectoris or coronary angioplasty, or stenting within \< six months prior to enrollment,
- Cardiac arrhythmia (ongoing cardiac dysrhythmias of grade \>=2 \[National Cancer Institute (NCI) CTCAE v5.0\]),
- Conditions that require intra-cardiac defibrillators,
- Known cardiac metastases,
- History of abnormal cardiac valve morphology (\>= grade 2),
- Chronic graft versus host disease (GVHD) or immunosuppressive therapy for the control of GVHD.
- PRIMARY TREATMENT: Severe infection within \< four weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
- PRIMARY TREATMENT: Inability or unwillingness to take oral medication (only for assigned oral study interventions).
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OHSU Knight Cancer Institutelead
- Genentech, Inc.collaborator
- Oregon Health and Science Universitycollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lara Davis
OHSU Knight Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 9, 2022
First Posted
February 14, 2022
Study Start
January 30, 2023
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
January 23, 2024
Record last verified: 2024-01