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A Phase II Randomized Therapeutic Optimization Trial for Subjects With Refractory Metastatic Colorectal Cancer Using ctDNA: Rapid 1 Trial

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ClinicalTrials.gov Identifier: NCT04786600
Recruitment Status : Recruiting
First Posted : March 8, 2021
Last Update Posted : November 21, 2022
Sponsor:
Collaborator:
Natera, Inc.
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE March 4, 2021
First Posted Date  ICMJE March 8, 2021
Last Update Posted Date November 21, 2022
Actual Study Start Date  ICMJE November 4, 2021
Estimated Primary Completion Date May 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2021)
Overall survival [ Time Frame: 1 year ]
Compare the overall survival in subjects who receive ctDNA assay-guided treatment and scan-guided treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2021)
  • Progression free survival [ Time Frame: 1 year ]
    Compare the progression free survival in subjects who receive ctDNA assay-guided treatment and scan-guided treatment
  • Best overall response [ Time Frame: 1 year ]
    Compare the proportion of subjects having each category of response during study participation (complete response, partial response, stable disease, and progressive disease) per RECIST v1.1 criteria
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II Randomized Therapeutic Optimization Trial for Subjects With Refractory Metastatic Colorectal Cancer Using ctDNA: Rapid 1 Trial
Official Title  ICMJE A Phase II Randomized Therapeutic Optimization Trial for Subjects With Refractory Metastatic Colorectal Cancer Using ctDNA: Rapid 1 Trial
Brief Summary This randomized, phase 2 study will investigate the use of the Signatera ctDNA assay versus the standard scan-based approach to guide treatment in patients with metastatic colorectal cancer. The aim of this study will be to measure and compare the overall survival, progression-free survival, and best overall response while on study of patients whose treatment has been guided by these two approaches.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Colorectal Cancer
Intervention  ICMJE
  • Device: Signatera ctDNA assay
    Subjects will be tested with the Signatera ctDNA assay every 2 weeks.
  • Drug: pre-specified sequence of FDA-approved drugs and drug combinations
    Subjects will receive treatment with a pre-specified sequence of FDA-approved drugs and drug combinations
Study Arms  ICMJE
  • Experimental: ctDNA assay-guided intervention
    Subjects on this arm will be tested with the Signatera ctDNA assay while receiving treatment on a pre-specified sequence of FDA-approved drugs and drug combinations. Subjects will move through this sequence based on the results of the ctDNA assay. Subjects will move to a new drug or drug combination in the sequence when the ctDNA assay indicates a significant increase in ctDNA level. Subjects will also have imaging scans every 12 weeks while on each drug or drug combination and subjects will move to a new drug or drug combination if these scans indicate disease progression.
    Interventions:
    • Device: Signatera ctDNA assay
    • Drug: pre-specified sequence of FDA-approved drugs and drug combinations
  • Active Comparator: Scan-guided Intervention
    Subjects on this arm will be treated with the same pre-specified sequence of FDA-approved drugs and drug combinations as those on the ctDNA assay- guided intervention arm. Subjects will move through the sequence based on the results of imaging scans, moving to a new drug or drug combination if imaging shows progressive disease.
    Intervention: Drug: pre-specified sequence of FDA-approved drugs and drug combinations
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 4, 2021)
78
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2025
Estimated Primary Completion Date May 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • A histologic confirmed adenocarcinoma of the colon or rectum with RECIST measurable metastatic disease measurable and not currently a candidate for oligometastatic definitive management
  • Must have at least received first-line oxaliplatin-based therapy for metastatic disease, or a clinically acceptable and documented reason they did not, and progressed or were intolerant to the therapy. Individuals who recurred within 6 months of completion of oxaliplatin based adjuvant chemotherapy are also eligible. Subjects may enroll at any line of therapy past this first line so long as the patient's next clinically reasonable prescribed treatment would be Folfiri + Bevacizumab/biosimilar, Anti-EGFR therapy (with or without irinotecan), OR Lonsurf.
  • Subjects must have tissue from either the primary and/or metastatic deposit available for submission at enrollment. Tissue can be from either a biopsy or resection surgery, whichever is most recent, but must be from the past five years.
  • Subjects must have tissue and blood shipped to Natera no fewer than 10 days prior to starting treatment.
  • Subjects must have had molecular profiling to determine tumor RAS, BRAF and MMR/MSI status
  • Subjects with known or suspected Gilbert's disease must be formally tested for UGT1A1*28 with results available to study team prior to treatment initiation
  • Any clinically relevant (as deemed by the PI) adverse events related to prior therapies must have resolved to Grade 1 or less (CTCAE 5.0) at study enrollment
  • Age ≥18 years
  • ECOG performance status of 0-2
  • Life expectancy of at least 6 months
  • Adequate organ function, as defined as:

    • Absolute neutrophil count (ANC) ≥ 1,500/µL
    • Hemoglobin ≥ 9g/dL
    • Platelets ≥ 100,000/µL
    • Total bilirubin ≤ 1.5 ULN or direct bilirubin ≤ 1 x ULN
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN; if liver metastases present, then AST and ALT must be ≤ 5 x ULN
    • Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 59 mL/min/1.73m using Cockcroft-Gault equation
  • Subjects must not have more than one active malignancy at the time of enrollment (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen [as determined by the treating physician and approved by the PI] may be included).
  • Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 12 weeks after the end of protocol-specified treatment to minimize the risk of pregnancy.
  • Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods throughout the study and should avoid conceiving children for 12 weeks following the last dose of the protocol-specified treatment.
  • Written informed consent obtained from the subject and the subject agrees to comply with all the study related procedures

Exclusion Criteria:

  • Colorectal cancer known to be Microsatellite High (MSI-H), deficient in DNA mismatch repair genes (dMMR), or BRAF (V600E) mutated
  • Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 12 weeks after the last dose of the protocol-specified treatment
  • Females who are pregnant or breastfeeding
  • History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician
  • Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness
  • Prior radiation therapy must have been completed 14 days prior to study entry
  • Prior chemotherapy or biologic therapy must have been completed 21 days prior to study entry
  • Known Dihydropyrimidine Dehydrogenase (DPD) deficiency
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alexandra Mueller, MS 352-273-9785 PMO@cancer.ufl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04786600
Other Study ID Numbers  ICMJE UF-STO-GI-012
UF-STO-GI-012 ( Other Identifier: University of Florida )
IRB202100341 ( Other Identifier: University of Florida )
OCR40199 ( Other Identifier: University of Florida )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Florida
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Florida
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Natera, Inc.
Investigators  ICMJE
Principal Investigator: Sherise Rogers, MD University of Florida
PRS Account University of Florida
Verification Date November 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP