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

Part of paid clinical trials in Portland, Oregon.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT03878524
Phase
PHASE1
Status
Terminated

Conditions

  • Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Anatomic Stage IV Breast Cancer AJCC v8
  • Anemia
  • Ann Arbor Stage III Hodgkin Lymphoma
  • Ann Arbor Stage III Non-Hodgkin Lymphoma
  • Ann Arbor Stage IV Hodgkin Lymphoma
  • Ann Arbor Stage IV Non-Hodgkin Lymphoma
  • Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
  • Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Castration-Resistant Prostate Carcinoma
  • Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Hematopoietic and Lymphoid System Neoplasm
  • Locally Advanced Pancreatic Adenocarcinoma
  • Metastatic Breast Carcinoma
  • Metastatic Malignant Solid Neoplasm
  • Metastatic Pancreatic Adenocarcinoma
  • Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis
  • Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
  • Primary Myelofibrosis
  • Recurrent Acute Lymphoblastic Leukemia
  • Recurrent Acute Myeloid Leukemia
  • Recurrent Chronic Lymphocytic Leukemia
  • Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Recurrent Hematologic Malignancy
  • Recurrent Hodgkin Lymphoma
  • Recurrent Myelodysplastic Syndrome
  • Recurrent Myelodysplastic/Myeloproliferative Neoplasm
  • Recurrent Myeloproliferative Neoplasm
  • Recurrent Non-Hodgkin Lymphoma
  • Recurrent Plasma Cell Myeloma
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory Acute Lymphoblastic Leukemia
  • Refractory Acute Myeloid Leukemia
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Refractory Chronic Myelomonocytic Leukemia
  • Refractory Hematologic Malignancy
  • Refractory Hodgkin Lymphoma
  • Refractory Malignant Solid Neoplasm
  • Refractory Myelodysplastic Syndrome
  • Refractory Myelodysplastic/Myeloproliferative Neoplasm
  • Refractory Non-Hodgkin Lymphoma
  • Refractory Plasma Cell Myeloma
  • Refractory Primary Myelofibrosis
  • Refractory Small Lymphocytic Lymphoma
  • Stage II Pancreatic Cancer AJCC v8
  • Stage III Pancreatic Cancer AJCC v8
  • Stage IV Pancreatic Cancer AJCC v8
  • Stage IV Prostate Cancer AJCC v8
  • Unresectable Pancreatic Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abemaciclib — DRUG
    Given PO
  • Abiraterone — DRUG
    Given PO
  • Afatinib — DRUG
    Given PO
  • Bevacizumab — BIOLOGICAL
    Given IV
  • Bicalutamide — DRUG
    Given PO
  • Biospecimen Collection — PROCEDURE
    Undergo collection of biospecimens (including tissue, blood, or previously collected archival specimens)
  • Bortezomib — DRUG
    Given IV
  • Cabazitaxel — DRUG
    Given IV
  • Cabozantinib — DRUG
    Given PO
  • Capecitabine — DRUG
    Given PO
  • Carboplatin — DRUG
    Given IV
  • Celecoxib — DRUG
    Given PO
  • Cobimetinib — DRUG
    Given PO
  • Copanlisib — DRUG
    Given IV
  • Dabrafenib — DRUG
    Given PO
  • Dacomitinib — DRUG
    Given PO
  • Darolutamide — DRUG
    Given PO
  • Dasatinib — DRUG
    Given PO
  • Doxorubicin — DRUG
    Given IV
  • Durvalumab — BIOLOGICAL
    Given IV
  • Enasidenib — DRUG
    Given PO
  • Entrectinib — DRUG
    Given PO
  • Enzalutamide — DRUG
    Given PO
  • Erlotinib — DRUG
    Given PO
  • Everolimus — DRUG
    Given PO
  • Fluorouracil — DRUG
    Given IV
  • Idelalisib — DRUG
    Given PO
  • Imatinib — DRUG
    Given PO
  • Ipilimumab — BIOLOGICAL
    Given IV
  • Lenvatinib — DRUG
    Given PO
  • Leucovorin — DRUG
    Given IV
  • Lorlatinib — DRUG
    Given PO
  • Losartan — DRUG
    Given PO
  • Nab-paclitaxel — DRUG
    Given IV
  • Neratinib — DRUG
    Given PO
  • Nivolumab — BIOLOGICAL
    Given IV
  • Olaparib — DRUG
    Given PO
  • Oxaliplatin — DRUG
    Given IV
  • Palbociclib — DRUG
    Given PO
  • Panobinostat — DRUG
    Given PO
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Pertuzumab — BIOLOGICAL
    Given IV
  • Ponatinib — DRUG
    Given PO
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Regorafenib — DRUG
    Given PO
  • Ruxolitinib — DRUG
    Given PO
  • Sirolimus — DRUG
    Given PO
  • Sorafenib — DRUG
    Given PO
  • Sunitinib — DRUG
    Given PO
  • Trametinib — DRUG
    Given PO
  • Trastuzumab Emtansine — BIOLOGICAL
    Given IV
  • Tretinoin — DRUG
    Given PO
  • Vemurafenib — DRUG
    Given PO
  • Venetoclax — DRUG
    Given PO
  • Vismodegib — DRUG
    Given PO
  • Vorinostat — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Apr 1, 2020
Status verified
Feb 2024
Primary completion
Dec 10, 2020
Completion
Dec 10, 2020

Study Design

Enrollment
2 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (biospecimen collection, 2 drug combination)
    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. 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 monthly and is anticipated to occur as follows: first month - 100% 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.

Primary Outcome Measure

Feasibility of implementing an individualized treatment strategy (number of participants to receive first dose) [ Time Frame: From date of tumor board recommendation to first dose of SMMART-PRIME Therapy #1 (up to 3 months) ]

Locations (1)

FacilityCityStateZIPSite coordinators
OHSU Knight Cancer InstitutePortlandOregon97239-

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By research site
OHSU Knight Cancer Institute· Portland, OR

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