18 and older, any sex, with Malignant Adrenal Gland Pheochromocytoma or Malignant Paraganglioma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Confirmed Tumor Response RatePrimary· Monthly, up to 17 months.
Will be defined as 100% times the number of eligible patients who has started lenvatinib and whose objective tumor status was a complete response or partial response on 2 consecutive evaluations at least 4 weeks apart (using Response Evaluation Criteria in Solid Tumors version 1.1 criteria) divided by the number of eligible patients who has started lenvatinib. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target
Group
Value
95% CI
Treatment (Lenvatinib)
1.0
Duration of Tumor ResponseSecondary· Every month until off treatment, at off treatment, every 3 months until PD, at PD, every 6 months after PD up to 17 months
Will be estimated using the Kaplan-Meier method.
Group
Value
95% CI
Treatment (Lenvatinib)
9.7
9.7 – NA
Patients Evaluable for Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 4.0Secondary· Monthly, up to 17 months.
Adverse Events are fully reported in the adverse event section of the results. All adverse events will be graded. For each type of adverse event classified as either possibly, probably, or definitely related to study treatment, the proportion of patients experiencing a severe (grade 3 or higher) adverse event will be noted per cycle. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns.
Group
Value
95% CI
Treatment (Lenvatinib)
3
Overall Survival TimeSecondary· Every month until off treatment, at off treatment, every 3 months until PD, at PD, every 6 months after PD up to 17 months
Will be estimated using the Kaplan-Meier method.
Group
Value
95% CI
Treatment (Lenvatinib)
NA
NA – NA
Progression-free SurvivalSecondary· Every month until off treatment, at off treatment, every 3 months until PD, at PD or up to 17 months
Will be estimated using the Kaplan-Meier method.
Group
Value
95% CI
Treatment (Lenvatinib)
11.5
5.5 – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Monthly, up to 17 months..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase II trial studies how well lenvatinib works in treating patients with pheochromocytoma or paraganglioma that has spread to other places in the body or cannot be removed by surgery. Lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04142398 — Incidence of HPV Infection and HPV-Associated Disease in Screening Indian Men Who Have Sex With HIV-Positive Men
· withdrawn
NCT04142385 — Incidence of HIV Infection in Screening Indian Men Who Have Sex With Men
· withdrawn
NCT05558904 — An Investigational Scan (Me-4FDG PET/CT) for the Detection of Sodium-Glucose Transport for Early Diagnosis of Lung Cance
· Phase 1, PHASE2
· recruiting
NCT05564650 — Navitoclax in Relapsed or Refractory High-Risk Myelodysplastic Syndrome
· Phase 1
· active not recruiting
NCT05396859 — Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia
· Phase 1
· active not recruiting
Other Mayo Clinic trials
Trials by the same sponsor.
NCT07126548 — A Point of Prostate Cancer Diagnosis Virtual Reality Assistant Intervention in Supporting Newly Diagnosed Black Men
· NA
· not yet recruiting
NCT07221656 — Evaluation of Prolonged Asparaginase Activity Levels After Calaspargase Pegol Administration
· not yet recruiting
NCT06891001 — The Utilization of a Shoe Insert on Individuals With Unilateral Greater Trochanteric Pain Syndrome on Single Leg Stance,
· NA
· not yet recruiting
NCT07169799 — Impact of Cryotherapy Spray (Tru-Freeze) for the Eradication of Gastric Antral Vascular Ectasia (ICE-GAVE)
· NA
· recruiting
NCT07086183 — Perioperative Risk in Patients on Chronic Aspirin Undergoing Craniotomy
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mayo Clinic
Last refreshed: 20 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03008369.