Trial · NCT03008369
Lenvatinib in Treating Patients With Metastatic or Advanced Pheochromocytoma or Paraganglioma That Cannot Be Removed by Surgery
NCT03008369, Phase 2, Completed, Mayo Clinic; results first posted 2021-05-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lenvatinib in Treating Patients With Metastatic or Advanced Pheochromocytoma or Paraganglioma That Cannot Be Removed by Surgery. Trials, record NCT03008369. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03008369
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lenvatinib in Treating Patients With Metastatic or Advanced Pheochromocytoma or Paraganglioma That Cannot Be Removed by Surgery
- NCT number
- NCT03008369
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Malignant Adrenal Gland Pheochromocytoma, Malignant Paraganglioma, Metastatic Adrenal Gland Pheochromocytoma
- Interventions
- Laboratory Biomarker Analysis, Lenvatinib, Quality-of-Life Assessment
- First posted
- 2017-01-02
- Last updated
- 2024-02-20
- Results first posted
- 2021-05-14
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Confirmed Tumor Response Rate | 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 lesions; Overall Response (OR) = CR + PR |
| Secondary | Duration of Tumor Response | 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. |
| Secondary | Patients Evaluable for Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 4.0 | 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. |
| Secondary | Overall Survival Time | 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. |
| Secondary | Progression-free Survival | 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. |
| Secondary | Quality of Life Assessed by EQ-5D and FACT-G | 5 years | Descriptive statistics, and scatter plots will form the basis of presentation of these data both overall and by other outcomes (toxicity, response and survival measures). Correlations between the quality of life outcomes and other outcome measures will be carried out by standard parametric and nonparametric tests (e.g. Pearson's and Spearman's rho). Comparison between continuous variables will be made with Wilcoxon rank sum tests, Fisher's exact tests will be used to determine differences between categorical variables, and Log-rank test will be used to test differences between time-to-event ou |
| Other | Changes in Urinary Catecholamine and Metanephrine Levels | Up to 5 years | Wilcoxon rank sum tests will be used to examine whether fold changes in a given biomarker during the first cycle of treatment differs between whose tumor responded to treatment and those whose tumor did not. Time series plots will be constructed. |
| Other | Germline Mutational Status in Peripheral Blood Mononuclear Cells | Up to 5 years | Will examine associations between tumor response and somatic mutational status in archived tumors, or germline mutational status in patient's peripheral blood mononuclear cells, (presence of SDHD, SDHB, RET, VHL, neurofibromatosis type-1). |
| Other | Somatic Mutational Status in Peripheral Blood Mononuclear Cells | Up to 5 years | Will examine associations between tumor response and somatic mutational status in archived tumors, or germline mutational status in patient's peripheral blood mononuclear cells, (presence of SDHD, SDHB, RET, VHL, neurofibromatosis type-1). |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Confirmed Tumor Response Rate | Monthly, up to 17 months. | participants | NUMBER | |
| SECONDARY | Duration of Tumor Response | Every month until off treatment, at off treatment, every 3 months until PD, at PD, every 6 months after PD up to 17 months | All treated patients | Months | MEDIAN |
| SECONDARY | Patients Evaluable for Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 4.0 | Monthly, up to 17 months. | All treated patients | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival Time | Every month until off treatment, at off treatment, every 3 months until PD, at PD, every 6 months after PD up to 17 months | All treated patients | Months | MEDIAN |
| SECONDARY | Progression-free Survival | Every month until off treatment, at off treatment, every 3 months until PD, at PD or up to 17 months | All treated patients | Months | MEDIAN |
| SECONDARY | Quality of Life Assessed by EQ-5D and FACT-G | 5 years | No patients made it to the QoL timepoint or submitted QoL data after treatment. | ||
| OTHER_PRE_SPECIFIED | Changes in Urinary Catecholamine and Metanephrine Levels | Up to 5 years | |||
| OTHER_PRE_SPECIFIED | Germline Mutational Status in Peripheral Blood Mononuclear Cells | Up to 5 years | |||
| OTHER_PRE_SPECIFIED | Somatic Mutational Status in Peripheral Blood Mononuclear Cells | Up to 5 years |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Confirmed Tumor Response Rate | Treatment (Lenvatinib) | 1.0 | participants | ||
| Duration of Tumor Response | Treatment (Lenvatinib) | 9.7 | 95% Confidence Interval 9.7 to NA | Months | |
| Patients Evaluable for Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 4.0 | Treatment (Lenvatinib) | 3 | Participants | ||
| Overall Survival Time | Treatment (Lenvatinib) | NA | 95% Confidence Interval NA to NA | Months | |
| Progression-free Survival | Treatment (Lenvatinib) | 11.5 | 95% Confidence Interval 5.5 to NA | Months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Lenvatinib) | 3 | |
| Overall Study | COMPLETED | Treatment (Lenvatinib) | 3 | |
| Overall Study | NOT COMPLETED | Treatment (Lenvatinib) | 0 |
Source ClinicalTrials.gov
Adverse events21
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hyperthyroidism | Endocrine disorders | Treatment (Lenvatinib) | 2 | 3 | 4 |
| other | Hypothyroidism | Endocrine disorders | Treatment (Lenvatinib) | 1 | 3 | 1 |
| other | Constipation | Gastrointestinal disorders | Treatment (Lenvatinib) | 1 | 3 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Lenvatinib) | 2 | 3 | 12 |
| other | Gastroesophageal reflux disease | Gastrointestinal disorders | Treatment (Lenvatinib) | 1 | 3 | 1 |
| other | Mucositis oral | Gastrointestinal disorders | Treatment (Lenvatinib) | 1 | 3 | 1 |
| other | Nausea | Gastrointestinal disorders | Treatment (Lenvatinib) | 2 | 3 | 11 |
| other | Vomiting | Gastrointestinal disorders | Treatment (Lenvatinib) | 1 | 3 | 1 |
| other | Fatigue | General disorders | Treatment (Lenvatinib) | 3 | 3 | 19 |
| other | Aspartate aminotransferase increased | Investigations | Treatment (Lenvatinib) | 1 | 3 | 1 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Lenvatinib) | 0 | 3 |
| Total, other adverse events | Treatment (Lenvatinib) | 3 | 3 |
| Total, serious adverse events | Treatment (Lenvatinib) | 1 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03008369
GET https://conductscience.org/api/trials/v1/NCT03008369/events?page=2