Trial · NCT03878524
Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial
NCT03878524, Phase 1, Terminated, OHSU Knight Cancer Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial. Trials, record NCT03878524. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03878524
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial
- NCT number
- NCT03878524
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 2 participants, actual
- Lead sponsor
- OHSU Knight Cancer Institute
- 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
Abemaciclib, Abiraterone, Afatinib, Bevacizumab, Bicalutamide, Biospecimen Collection, Bortezomib, Cabazitaxel, Cabozantinib, Capecitabine, Carboplatin, Celecoxib, Cobimetinib, Copanlisib, Dabrafenib, Dacomitinib, Darolutamide, Dasatinib, Doxorubicin, Durvalumab, Enasidenib, Entrectinib, Enzalutamide, Erlotinib, Everolimus, Fluorouracil, Idelalisib, Imatinib, Ipilimumab, Lenvatinib, Leucovorin, Lorlatinib, Losartan, Nab-paclitaxel, Neratinib, Nivolumab, Olaparib, Oxaliplatin, Palbociclib, Panobinostat, Pembrolizumab, Pertuzumab, Ponatinib, Quality-of-Life Assessment, Regorafenib, Ruxolitinib, Sirolimus, Sorafenib, Sunitinib, Trametinib, Trastuzumab Emtansine, Tretinoin, Vemurafenib, Venetoclax, Vismodegib, Vorinostat
- First posted
- 2019-03-18
- Last updated
- 2024-03-04
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Feasibility of implementing an individualized treatment strategy (number of participants to receive first dose) | From date of tumor board recommendation to first dose of SMMART-PRIME Therapy #1 (up to 3 months) | Measured as the number of participants to receive the first dose of Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART)-PRIME therapy (Therapy #1) within 3 months from the date of Clinical Tumor Board providing a recommended drug combination. |
| Secondary | Incidence of grade 3+ toxicities attributable to assigned study drug(s) | 30 days post completion of each SMMART-PRIME Therapy (up to 6 months) | Measured with National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Criteria version 5.0. |
| Secondary | Time to treatment discontinuation | Completion of SMMART-PRIME Therapy #1 (up to 6 months) | Measured as time (days) from start of SMMART-PRIME Therapy #1 to discontinuation for any reason. |
| Secondary | Overall survival (OS) | Death from any cause (up to 60 months after the last dose of SMMART-PRIME Therapy #1) | Overall survival (OS) is defined as the time (days) from start of SMMART-PRIME Therapy #1 to death from any reason. |
| Secondary | Time to decline (TTD) | Completion of SMMART-PRIME Therapy #1 (up to 6 months) | Measured time (days) from start of SMMART-PRIME Therapy #1 to recorded Eastern Cooperative Oncology Group (ECOG) performance status \>= 3 using cumulative incidence methods. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39863139 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03878524
GET https://conductscience.org/api/trials/v1/NCT03878524/registered