Health TrialsbyHealthPanel

ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST

ConditionGastrointestinal Stromal Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami

About this trial

The purpose of this research is to test if mutations (changes in DNA) in exons (segment of DNA or RNA containing information that has the instructions for making proteins) in the KIT gene can be used to predict the body's response to standard of care treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who are ≥ 18 years of age.

Patients who have histologically confirmed metastatic or unresectable GIST. Unresectable GIST must be confirmed to be unresectable by an experienced surgeon.

Patients who received imatinib prior treatment regimens, including adjuvant therapy, with objective disease progression, inadequate clinical benefit, or intolerance. Additionally, disease progression or intolerance to other systemic therapies including investigational agents and radiotherapy is allowed. Patients who experienced intolerance to prior therapies must have objective disease progression prior to enrollment.

Patients who have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2.

Disqualifiers

Patients who have received prior treatment with sunitinib or regorafenib.

Patients who have received more than 2 different prior tyrosine kinase inhibitor (TKI) treatment regimens. If a patient receives the same TKI more than once sequentially (eg, imatinib followed by a period without systemic therapy and retreatment with imatinib), that will be counted as a single TKI treatment regimen.

Patients who are known to be KIT wild type.

Patients who received any systemic anticancer therapy within 2 weeks before. Prior radiotherapy to major organs within 2 weeks of admission, or focal radiotherapy, such as to bones, limbs, or other areas not involving major organs, within 3 days.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sunitinib

    Drug

    37.5 mg of Sunitinib orally (PO), once daily on a 28-day treatment cycle.

  • Regorafenib

    Drug

    120.0 mg of Regorafenib, once daily by mouth 3 weeks on 1 week off on a 4-week treatment cycle.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Group A: KIT Exon 13 receiving SunitinibExperimental treatment 2 interventions
Group B: Group B: KIT Exon 17 receiving RegorafenibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of Participants Achieving Overall Response

The overall response rate (ORR) will be defined as the number of evaluable patients whose best overall response to study treatment is complete response (CR) or partial response (PR). ORR will be assessed using Choi criteria by treating physician.

Time frame
Up to 12 months

Secondary outcomes

1

Progression-Free Survival (PFS)

Progression-free survival (PFS) will be defined as the time elapsed from the start of treatment to the date of documented progression or death, whichever comes first. For surviving patients without progression who begin alternative treatment, PFS will be censored at the last date of documented progression-free status prior to starting alternative treatment. Similarly, losses to follow up will be censored at the last date of documented progression-free status.

Time frame
Up to 3 years
2

Overall Survival (OS)

Overall survival (OS) will be defined as the time elapsed from the start of treatment until death. For surviving patients, follow-up will be censored at the date of last contact.

Time frame
Up to 3 years
3

Number of Participants Achieving Clinical Benefit

The clinical benefit rate (CBR) will be defined as the number of evaluable patients whose best overall response to study treatment is complete response (CR), or partial response (PR), or stable disease (SD), for 6 months or more and will be assessed using Choi criteria by treating physician.

Time frame
Up to 12 months
4

Incidence of Treatment-Related Toxicity and Adverse Events

Safety and tolerability of assigned Sunitinib and Regorafenib treatment will be reported as the incidence of treatment-related toxicity, including serious adverse events (SAEs) and adverse events (AEs), in study participants using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.

Time frame
Up to 13 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

Source ClinicalTrials.gov
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