SMMART Adaptive Clinical Treatment (ACT) Trial

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT05238831
Phase
EARLY_PHASE1
Status
Withdrawn

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

Eligibility Criteria

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

Interventions

  • Alectinib — DRUG
    Given orally (PO)
  • Alpelisib — DRUG
    Given PO
  • Anastrozole — DRUG
    Given PO
  • Atezolizumab — BIOLOGICAL
    Given IV
  • Bevacizumab — BIOLOGICAL
    Given IV
  • Biopsy — PROCEDURE
    Undergo tissue biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood
  • Capecitabine — DRUG
    Given PO
  • Carboplatin — DRUG
    Given IV
  • Cobimetinib — DRUG
    Given PO
  • Entrectinib — DRUG
    Given PO
  • Eribulin — DRUG
    Given IV
  • Fulvestrant — DRUG
    Given by injection
  • Hyaluronidase-zzxf/Pertuzumab/Trastuzumab — BIOLOGICAL
    Given phesgo SC
  • Irinotecan — DRUG
    Given IV
  • Letrozole — DRUG
    Given PO
  • Nab-paclitaxel — DRUG
    Given IV
  • Niraparib — DRUG
    Given PO
  • Olaparib — DRUG
    Given PO
  • Paclitaxel — DRUG
    Given IV
  • Palbociclib — DRUG
    Given IV
  • Pertuzumab — BIOLOGICAL
    Given subcutaneously (SC)
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Trastuzumab — BIOLOGICAL
    Given SC
  • Trastuzumab Emtansine — BIOLOGICAL
    Given intravenously (IV)
  • Vemurafenib — DRUG
    Given PO
  • Vinorelbine — DRUG
    Given IV
  • Vismodegib — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Jan 30, 2023
Status verified
Jan 2024
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (SMMART-ACT)
    Administered in monotherapy or in combination with other targeted agents or immunotherapies, chemotherapies, or radiation. Combination treatment plans may include a two-week monotherapy lead-in, followed by a combination treatment regimen. Each ACT study intervention must have an established RP2D determined in a prior clinical trial. Participants undergo a Pre-Treatment Biopsy, plus an On-Treatment Biopsy after two weeks on first dose of study drug(s) and prior to starting Cycle 2, regardless of regimen. Participants continue to receive study agent(s) after the On-Treatment Biopsy, according to the biopsy results and the results of ongoing safety and clinical assessments. Treatment cycles repeat every 21 to 28 days in the absence of disease progression or unacceptable toxicity. Cycles are determined based on the study agent(s). Upon disease progression, participants are given the option to undergo an additional biopsy.

Primary Outcome Measure

Proportion of participants who receive an ACT therapy based an ACT Tumor Board recommendation. [ Time Frame: From time of SMMART-ACT Tumor Board review to first dose of SMMART-ACT study drug regime as evaluated at interim analysis (approximately 2 years) ]

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