Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial (NCT03878524) | Clinical Trial Compass
TerminatedPhase 1
Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial
Stopped: Low accrual
United States2 participantsStarted 2020-04-01
Plain-language 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.
Who can participate
Age range21 Years
SexALL
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Key Inclusion Criteria:
* Ability to understand and the willingness to sign a written informed consent document
* Participants \>= 21 years old at time of informed consent. Both men and women and members of all races and ethnic groups will be included
* Participants, both men and women, must agree to use an adequate method of contraception prior to study entry, for the duration of study participation, and for 4 months after completion of study
* Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to start of study drug administration
* Patients must have a histologically or cytologically-confirmed metastatic solid tumor or hematological malignancy that has progressed as follows:
* Patients with a solid tumor must have metastatic disease and have progressed on at least 1 line of established therapy that is known to provide clinical benefit, or for whom no standard curative therapy exists. Participants with newly diagnosed, unresectable, locally-advanced or metastatic pancreatic adenocarcinoma and are beginning first-line treatment with a course of chemotherapy are eligible OR
* Participants must have a hematological malignancy that is advanced, relapsed, or refractory to at least 1 line of established therapy that is known to provide clinical for the treatment of their disease. Hematological disease included in this study are as follows:
* Acute myelogenous leukemia (AML), or
* Myelodysplastic syndrome (MDS), o…
What they're measuring
1
Feasibility of implementing an individualized treatment strategy (number of participants to receive first dose)
Timeframe: From date of tumor board recommendation to first dose of SMMART-PRIME Therapy #1 (up to 3 months)