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Metastatic Colorectal CancerPhase 2NCT04786600

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

A Phase 2 study testing Signatera ctDNA assay and pre-specified sequence of FDA-approved drugs and drug combinations in people with Metastatic Colorectal Cancer, run by University of Florida at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Signatera ctDNA assay and pre-specified sequence of FDA-approved drugs and drug combinations
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
14 Mar 2022to 19 Mar 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 21Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Florida

    Gainesville, Florida, 32608

Other trials in United States

About this study

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.

Being tested
Signatera ctDNA assay, pre-specified sequence of FDA-approved drugs and drug combinations
Keywords
metastatic colorectal cancer, precision oncology, personalized medicine, ctDNA
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Signatera ctDNA assayDevice

    Subjects will be tested with the Signatera ctDNA assay every 2 weeks.

  • pre-specified sequence of FDA-approved drugs and drug combinationsDrug

    Subjects will receive treatment with a pre-specified sequence of FDA-approved drugs and drug combinations

Study groups in NCT04786600
Study groupRoleWhat they receive
ctDNA assay-guided interventionExperimentalSubjects 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.
Receives: Device: Signatera ctDNA assay; Drug: pre-specified sequence of FDA-approved drugs and drug combinations
Scan-guided InterventionActive comparatorSubjects 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.
Receives: Drug: pre-specified sequence of FDA-approved drugs and drug combinations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Determine the overall survival

    Measured: 580 days

Secondary outcomes (2)

  1. Best Overall Treatment Response

    Compare the proportion of subjects who receive ctDNA-guided treatment and scan-guided treatment that achieve each RECIST v1.1 response category (complete response, partial response, stable disease, and progressive disease) as their best response while on study treatment. Complete response is defined as the disappearance of all target lesions (any pathological lymph nodes must have reduction in short axis to <10 mm). Partial response is defined as least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of 1 or more new lesions is also considered progression. Stable disease is defined as either sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

    Measured: 1 year

  2. Progression-free Survival

    Determine progression-free survival

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2021
  2. Study start14 Mar 2022
  3. Primary completion19 Mar 2024
  4. Study completion19 Mar 2024

Why it stopped: slow accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04786600
Sponsor's protocol ID
UF-STO-GI-012
Other IDs
UF-STO-GI-012, IRB202100341, OCR40199
Status last verified
Jun 2025
First submitted
4 Mar 2021
Last updated
1 Jul 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Signatera ctDNA assay and pre-specified sequence of FDA-approved drugs and drug combinations in people with Metastatic Colorectal Cancer, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: 580 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04786600.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.

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Clinical Trial NCT04786600 | AzTrials