Zanzalintinib in Unresectable and Progressive MPGGs
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute
About this trial
This study is to examine the effects of oral daily zanzalintinib in participants with unresectable, progressive metastatic pheochromocytoma or paraganglioma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years. As no dosing or adverse event data are currently available in participants < 18 years of age, children and adolescents are excluded from this study.
Documentation of Disease
Histologic Documentation: Histologically-proven advanced (metastatic or unresectable primary) pheochromocytoma or paraganglioma.
Stage: Advanced (metastatic or unresectable primary) disease
Disqualifiers
Received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (eg, cytokines or antibodies) within 3 weeks, or nitrosoureas/ mitomycin C within 6 weeks before the first dose of study treatment.
Prior treatment with zanzalintinib
Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
Received radionuclide treatment (i.e. I 131 meta-iodo- benzyl guanidine) within 6 months of the first dose of study treatment
Trial design
Design model
Single group
Treatments tested in this trial
Zanzalintinib
DrugRoute: Oral Schedule: Daily
Treatment groups
14 Participants
are divided into 1 treatment groupGroup A: ZanzalintinibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR)
ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Time frame
Assessed every 8 weeks during treatment. The estimated treatment duration is up to 16 months.Secondary outcomes
1
Median Progression-Free Survival (PFS)
PFS based on Kaplan-Meier method is defined as the time from registration to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.
Time frame
Assessed every 8 weeks during treatment. The treatment duration is up to 16 months. If treatment discontinued prior to progression, participants will be followed every 3 months for up to 52 weeks or until death.2
Median Overall Survival (OS)
OS based on Kaplan-Meier method is defined as the time from registration to death due to any cause, or censored at date last known alive.
Time frame
Treatment duration is up to 16 months. Following treatment discontinuation, participants will be followed every 3 months for up to 52 weeks or until death.3
Global Adverse Event (AE) Rate
Global AE rate is defined as the proportion of participants who experience at least one adverse event during the treatment period. Aes are summerized and graded based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame
AE will be assessed every 2 weeks through Week 8 and every 4 weeks thereafter until the end of treatment (up to 16 months).4
Blood Pressure Control Rate
The blood pressure control rate is defined as the proportion of participants who require the addition or discontinuation of antihypertensive medication during the treatment period.
Time frame
Assessed every 8 weeks on treatment. Treatment duration is up to 16 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dana-Farber Cancer Institute
Lead sponsor
Exelixis
Collaborator
Source ClinicalTrials.gov
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