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

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.

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

Interventions

DRUG

Abemaciclib

Given PO

DRUG

Abiraterone

Given PO

DRUG

Afatinib

Given PO

BIOLOGICAL

Bevacizumab

Given IV

DRUG

Bicalutamide

Given PO

PROCEDURE

Biospecimen Collection

Undergo collection of biospecimens (including tissue, blood, or previously collected archival specimens)

DRUG

Bortezomib

Given IV

DRUG

Cabazitaxel

Given IV

DRUG

Cabozantinib

Given PO

DRUG

Capecitabine

Given PO

DRUG

Carboplatin

Given IV

DRUG

Celecoxib

Given PO

DRUG

Cobimetinib

Given PO

DRUG

Copanlisib

Given IV

DRUG

Dabrafenib

Given PO

DRUG

Dacomitinib

Given PO

DRUG

Darolutamide

Given PO

DRUG

Dasatinib

Given PO

DRUG

Doxorubicin

Given IV

BIOLOGICAL

Durvalumab

Given IV

DRUG

Enasidenib

Given PO

DRUG

Entrectinib

Given PO

DRUG

Enzalutamide

Given PO

DRUG

Erlotinib

Given PO

DRUG

Everolimus

Given PO

DRUG

Fluorouracil

Given IV

DRUG

Idelalisib

Given PO

DRUG

Imatinib

Given PO

BIOLOGICAL

Ipilimumab

Given IV

DRUG

Lenvatinib

Given PO

DRUG

Leucovorin

Given IV

DRUG

Lorlatinib

Given PO

DRUG

Losartan

Given PO

DRUG

Nab-paclitaxel

Given IV

DRUG

Neratinib

Given PO

BIOLOGICAL

Nivolumab

Given IV

DRUG

Olaparib

Given PO

DRUG

Oxaliplatin

Given IV

DRUG

Palbociclib

Given PO

DRUG

Panobinostat

Given PO

BIOLOGICAL

Pembrolizumab

Given IV

BIOLOGICAL

Pertuzumab

Given IV

DRUG

Ponatinib

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

DRUG

Regorafenib

Given PO

DRUG

Ruxolitinib

Given PO

DRUG

Sirolimus

Given PO

DRUG

Sorafenib

Given PO

DRUG

Sunitinib

Given PO

DRUG

Trametinib

Given PO

BIOLOGICAL

Trastuzumab Emtansine

Given IV

DRUG

Tretinoin

Given PO

DRUG

Vemurafenib

Given PO

DRUG

Venetoclax

Given PO

DRUG

Vismodegib

Given PO

DRUG

Vorinostat

Given PO

Sponsors & Collaborators

• Oregon Health and Science University

  collaborator OTHER

• OHSU Knight Cancer Institute

  lead OTHER

Principal Investigators

• Lara Davis, MD · OHSU Knight Cancer Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-04-01

Primary Completion

2020-12-10

Completion

2020-12-10

FDA Drug

Yes

Countries

• United States

Study Locations