SMMART Adaptive Clinical Treatment (ACT) Trial
NCT05238831 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL
Last updated 2024-01-23
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.
Conditions
- Advanced Breast Carcinoma
- Advanced Malignant Solid Neoplasm
- Advanced Ovarian Carcinoma
- Advanced Pancreatic Carcinoma
- Advanced Prostate Carcinoma
- Advanced Sarcoma
- Anatomic Stage III Breast Cancer AJCC v8
- Anatomic Stage IV Breast Cancer AJCC v8
- Recurrent Adult Soft Tissue Sarcoma
- Recurrent Breast Carcinoma
- Recurrent Ovarian Carcinoma
- Recurrent Prostate Carcinoma
- Stage II Pancreatic Cancer AJCC v8
- Stage III Ovarian Cancer AJCC v8
- Stage III Pancreatic Cancer AJCC v8
- Stage IV Ovarian Cancer AJCC v8
- Stage IV Pancreatic Cancer AJCC v8
Interventions
- DRUG
-
Alectinib
Given orally (PO)
- DRUG
-
Alpelisib
Given PO
- DRUG
-
Anastrozole
Given PO
- BIOLOGICAL
-
Given IV
- BIOLOGICAL
-
Given IV
- PROCEDURE
-
Biopsy
Undergo tissue biopsy
- PROCEDURE
-
Biospecimen Collection
Undergo collection of blood
- DRUG
-
Given PO
- DRUG
-
Given IV
- DRUG
-
Cobimetinib
Given PO
- DRUG
-
Entrectinib
Given PO
- DRUG
-
Eribulin
Given IV
- DRUG
-
Given by injection
- BIOLOGICAL
-
Hyaluronidase-zzxf/Pertuzumab/Trastuzumab
Given phesgo SC
- DRUG
-
Given IV
- DRUG
-
Given PO
- DRUG
-
Given IV
- DRUG
-
Niraparib
Given PO
- DRUG
-
Given PO
- DRUG
-
Given IV
- DRUG
-
Given IV
- BIOLOGICAL
-
Given subcutaneously (SC)
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
- BIOLOGICAL
-
Given SC
- BIOLOGICAL
-
Trastuzumab Emtansine
Given intravenously (IV)
- DRUG
-
Vemurafenib
Given PO
- DRUG
-
Given IV
- DRUG
-
Vismodegib
Given PO
Sponsors & Collaborators
-
Genentech, Inc.
collaborator INDUSTRY -
Oregon Health and Science University
collaborator OTHER -
OHSU Knight Cancer Institute
lead OTHER
Principal Investigators
-
Lara Davis · OHSU Knight Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-30
- Primary Completion
- 2026-05-31
- Completion
- 2026-05-31
- FDA Drug
- Yes
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