Trial Outcomes & Findings for A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced Sarcoma, Prostate, Breast, Ovarian or Pancreatic Cancer (NCT NCT06630325)

Results Overview

A threshold of the posterior probability rate of 75% will be utilized for declaring feasibility to support the analysis of the primary objective in this pilot.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

From SMMART-ACT tumor board review to the first dose of ACT study drug per unique treatment regimen. This is expected to take up to approximately 30 days.

Results posted on

2026-04-28

Participant Flow

Six participants were consented to the Pre-Screening portion of this study. As per protocol, any participant that receives an ACT Tumor Board treatment recommendation, whether or not the recommendation is an ACT Therapy option, will be considered enrolled. Based on this definition six participants were enrolled. However, zero participants went on to receive an ACT Therapy.

Participant milestones

Participant milestones
Measure	Pre-Screening This Pre-Screening "arm" is added to account for the 6 participants who were enrolled but who did not go on to any of the study therapy arms.	Arm I (Abemaciclib, Gemcitabine) Patients receive abemaciclib PO BID on days 1-21 and gemcitabine IV over 30 minutes on days 1 and 8 of each cycle. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.	Arm II (Abemaciclib, Pemetrexed) Patients receive abemaciclib PO BID on days 1-21 and pemetrexed IV over 10 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.	Arm III (Abemaciclib) Patients receive abemaciclib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.	Arm IV (Abemaciclib, Exemestane) Patients receive abemaciclib PO BID and exemestane PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.	Arm V (Abemaciclib, Letrozole) Patients receive abemaciclib PO BID and letrozole PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.	Arm VI (Abemaciclib, Tamoxifen) Patients receive abemaciclib PO BID and tamoxifen PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.	Arm VII (Osimertinib) Patients receive osimertinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography or MUGA scan and blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.
Overall Study STARTED	6	0	0	0	0	0	0	0
Overall Study COMPLETED	6	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

No participants received study therapy.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm III (Abemaciclib) Patients receive abemaciclib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.	Arm IV (Abemaciclib, Exemestane) Patients receive abemaciclib PO BID and exemestane PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.	Arm V (Abemaciclib, Letrozole) Patients receive abemaciclib PO BID and letrozole PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.	Arm VI (Abemaciclib, Tamoxifen) Patients receive abemaciclib PO BID and tamoxifen PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.	Arm VII (Osimertinib) Patients receive osimertinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography or MUGA scan and blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.	Total n=6 Participants Total of all reporting groups	Pre-Screen n=6 Participants Pre-Screening added as an "arm" to account for participants who were enrolled but who did not go on to receive study therapy under any of the study arms.	Arm I (Abemaciclib, Gemcitabine) Patients receive abemaciclib PO BID on days 1-21 and gemcitabine IV over 30 minutes on days 1 and 8 of each cycle. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.	Arm II (Abemaciclib, Pemetrexed) Patients receive abemaciclib PO BID on days 1-21 and pemetrexed IV over 10 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study and optionally at the end of treatment. Additionally, prostate cancer patients undergo bone scan on study.
Age, Categorical <=18 years	0 Participants No participants received study therapy.	0 Participants No participants received study therapy.	0 Participants No participants received study therapy.	0 Participants No participants received study therapy.	0 Participants No participants received study therapy.	0 Participants n=6 Participants • No participants received study therapy.	0 Participants n=6 Participants • No participants received study therapy.	0 Participants No participants received study therapy.	0 Participants No participants received study therapy.
Age, Categorical Between 18 and 65 years	0 Participants No participants received study therapy.	0 Participants No participants received study therapy.	0 Participants No participants received study therapy.	0 Participants No participants received study therapy.	0 Participants No participants received study therapy.	3 Participants n=6 Participants • No participants received study therapy.	3 Participants n=6 Participants • No participants received study therapy.	0 Participants No participants received study therapy.	0 Participants No participants received study therapy.
Age, Categorical >=65 years	0 Participants No participants received study therapy.	0 Participants No participants received study therapy.	0 Participants No participants received study therapy.	0 Participants No participants received study therapy.	0 Participants No participants received study therapy.	3 Participants n=6 Participants • No participants received study therapy.	3 Participants n=6 Participants • No participants received study therapy.	0 Participants No participants received study therapy.	0 Participants No participants received study therapy.
Sex: Female, Male Female	0 Participants No participants received study therapy.	0 Participants No participants received study therapy.	0 Participants No participants received study therapy.	0 Participants No participants received study therapy.	0 Participants No participants received study therapy.	6 Participants n=6 Participants • No participants received study therapy.	6 Participants n=6 Participants • No participants received study therapy.	0 Participants No participants received study therapy.	0 Participants No participants received study therapy.
Sex: Female, Male Male	0 Participants No participants received study therapy.	0 Participants No participants received study therapy.	0 Participants No participants received study therapy.	0 Participants No participants received study therapy.	0 Participants No participants received study therapy.	0 Participants n=6 Participants • No participants received study therapy.	0 Participants n=6 Participants • No participants received study therapy.	0 Participants No participants received study therapy.	0 Participants No participants received study therapy.
Race and Ethnicity Not Collected	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.	—	—	—

PRIMARY outcome

Timeframe: From SMMART-ACT tumor board review to the first dose of ACT study drug per unique treatment regimen. This is expected to take up to approximately 30 days.