Clinical Trials Directory

Trials / Terminated

TerminatedNCT03878524

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) Trial: PRIME

Status
Terminated
Phase
Phase 1
Study type
Interventional
Enrollment
2 (actual)
Sponsor
OHSU Knight Cancer Institute · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

Summary

This phase Ib trial determines if samples from a patient's cancer can be tested to find combinations of drugs that provide clinical benefit for the kind of cancer the patient has. This study is also being done to understand why cancer drugs can stop working and how different cancers in different people respond to different types of therapy.

Detailed description

PRIMARY OBJECTIVE: I. To determine the feasibility of implementing an individualized treatment strategy for advanced solid tumor and hematological malignancies based upon a comprehensive assessment of tumor and patient characteristics. SECONDARY OBJECTIVES: I. To describe the tolerability of implementing an individualized treatment strategy, particularly by measuring unanticipated toxicity associated with the administration of different combinations of two therapeutic agents given to an individual participant. II. To assess the duration of treatment for participants receiving Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART)-PRIME Therapy #1. III. To determine overall survival of participants with advanced solid tumors and hematological malignancies. IV. To determine the time to decline in a participant's ability to perform activities of daily living. EXPLORATORY OBJECTIVES: I. To measure quality of life among enrolled participants. II. To evaluate immune-mediated tumor response among participants receiving an immunomodulatory study drug. III. To determine the rates of response and benefit to SMMART-PRIME Therapy #1, as an individualized treatment strategy for participants with advanced solid tumor and hematological malignancies. IV. To determine the progression-free and disease-free survival of participants with advanced solid tumors and hematological malignancies. OUTLINE: TUMOR BIOPSY: Patients undergo collection of tissue samples. Clinical analytics are performed on the samples and analyzed by a clinical tumor board to recommend a treatment option based on those analytics. The findings from these Clinical Study Analytics are intended to provide the basis for selection of two drugs that, when administered in combination, provide an optimal and individualized treatment approach. This may or may not include a SMMART-PRIME treatment. The decision to initiate any SMMART-PRIME Therapy ultimately resides with the treating physician in conjunction with the study participant. SMMART-PRIME TREATMENT: Patients receive a combination of 2 drugs (Drug A and Drug B, selected from interventions below). Doses will be escalated within individual patients over time. As described in detail below, escalation will occur on a monthly basis and is anticipated to occur as follows: first month -- 100% Food and Drug Administration (FDA) approved dose Drug A + 25% FDA approved dose Drug B; second month -- 100% dose Drug A + 50% dose Drug B; third month -- 100% dose Drug A + 100% dose Drug B. All dose-escalations will be reviewed and approved by an independent consultant outside of Oregon Health \& Science University (OHSU). Treatment will continue for up to the end of 6 treatment cycles (cycle length is between 21-28 days) in the absence of disease progression or unacceptable toxicity. Patients whose treatment is discontinued as a result of excess toxicity or lack of efficacy may switch to a different combination of drugs. Beyond six cycles, participants will be considered off-protocol directed treatment, and will move into long term follow-up. After completion of study treatment, patients are followed for up to 5 years.

Conditions

Interventions

TypeNameDescription
DRUGAbemaciclibGiven PO
DRUGAbirateroneGiven PO
DRUGAfatinibGiven PO
BIOLOGICALBevacizumabGiven IV
DRUGBicalutamideGiven PO
PROCEDUREBiospecimen CollectionUndergo collection of biospecimens (including tissue, blood, or previously collected archival specimens)
DRUGBortezomibGiven IV
DRUGCabazitaxelGiven IV
DRUGCabozantinibGiven PO
DRUGCapecitabineGiven PO
DRUGCarboplatinGiven IV
DRUGCelecoxibGiven PO
DRUGCobimetinibGiven PO
DRUGCopanlisibGiven IV
DRUGDabrafenibGiven PO
DRUGDacomitinibGiven PO
DRUGDarolutamideGiven PO
DRUGDasatinibGiven PO
DRUGDoxorubicinGiven IV
BIOLOGICALDurvalumabGiven IV
DRUGEnasidenibGiven PO
DRUGEntrectinibGiven PO
DRUGEnzalutamideGiven PO
DRUGErlotinibGiven PO
DRUGEverolimusGiven PO
DRUGFluorouracilGiven IV
DRUGIdelalisibGiven PO
DRUGImatinibGiven PO
BIOLOGICALIpilimumabGiven IV
DRUGLenvatinibGiven PO
DRUGLeucovorinGiven IV
DRUGLorlatinibGiven PO
DRUGLosartanGiven PO
DRUGNab-paclitaxelGiven IV
DRUGNeratinibGiven PO
BIOLOGICALNivolumabGiven IV
DRUGOlaparibGiven PO
DRUGOxaliplatinGiven IV
DRUGPalbociclibGiven PO
DRUGPanobinostatGiven PO
BIOLOGICALPembrolizumabGiven IV
BIOLOGICALPertuzumabGiven IV
DRUGPonatinibGiven PO
OTHERQuality-of-Life AssessmentAncillary studies
DRUGRegorafenibGiven PO
DRUGRuxolitinibGiven PO
DRUGSirolimusGiven PO
DRUGSorafenibGiven PO
DRUGSunitinibGiven PO
DRUGTrametinibGiven PO
BIOLOGICALTrastuzumab EmtansineGiven IV
DRUGTretinoinGiven PO
DRUGVemurafenibGiven PO
DRUGVenetoclaxGiven PO
DRUGVismodegibGiven PO
DRUGVorinostatGiven PO

Timeline

Start date
2020-04-01
Primary completion
2020-12-10
Completion
2020-12-10
First posted
2019-03-18
Last updated
2024-03-04

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03878524. Inclusion in this directory is not an endorsement.

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial (NCT03878524) · Clinical Trials Directory