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

Part of paid clinical trials in Portland, Oregon.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT06630325
Phase
PHASE2
Status
Terminated

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
  • Stage III Ovarian Cancer AJCC v8
  • Stage III Pancreatic Cancer AJCC v8
  • Stage III Prostate Cancer AJCC v8
  • Stage IV Ovarian Cancer AJCC v8
  • Stage IV Pancreatic Cancer AJCC v8
  • Stage IV Prostate Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abemaciclib — DRUG
    Given PO
  • Biopsy — PROCEDURE
    Undergo tumor biopsy
  • Bone Scan — PROCEDURE
    Undergo bone scan
  • Echocardiography — PROCEDURE
    Undergo echocardiography
  • Exemestane — DRUG
    Given PO
  • Gemcitabine — DRUG
    Given IV
  • Letrozole — DRUG
    Given PO
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Osimertinib — DRUG
    Given PO
  • Pemetrexed — DRUG
    Given IV
  • Survey Administration — OTHER
    Ancillary studies
  • Tamoxifen — DRUG
    Given PO
  • Biospecimen Collection — PROCEDURE
    Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection

Study Details

This phase II trial tests the how well a precision medicine approach (serial measurements of molecular and architectural response to therapy \[SMMART\])-adaptive clinical treatment \[ACT\]) works in treating patients with sarcoma, prostate, breast, ovarian or pancreatic cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). SMMART testing uses genetic and protein tests to learn how cancer changes and to understand what drugs may work against a person's cancer or why drugs stop working. These test results are reviewed by a group of physicians and scientists during a SMMART tumor board who then recommend precision therapy.

Key Dates

Start date
Jun 24, 2025
Status verified
Apr 2026
Primary completion
Mar 11, 2026
Completion
Mar 11, 2026

Study Design

Enrollment
6 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Proportion of Participants Who Receive an ACT Therapy Based on a SMMART-ACT Tumor Board Recommendation. [ Time Frame: 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. ]

Locations (1)

FacilityCityStateZIP
OHSU Knight Cancer InstitutePortlandOregon97239

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