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A Prospective Phase II Efficacy and Safety Study of Anlotinib in Metastatic or Locally Advanced Pheochromocytoma/ Paraganglioma : Open-label Single-arm, Exploratory Trial

NCT05133349 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-11-24

No results posted yet for this study

Summary

This is an open-label phase II study of an investigational drug, anlotinib in participants with advanced malignant paraganglioma or pheochromocytoma. Pheochromocytoma and paraganglioma (PPGL) are tumors originating from the adrenal medulla or adrenal diplomatic sensory chain, respectively, which can synthesize and secrete large amounts of catecholamines. In this study, participants whose disease has advanced or spread despite prior standard therapy, will receive anlotinib for 2-weeks followed by a 1-week rest period, until disease progression (PD) or drug toxicity intolerance. Anlotinib is an investigational drug, which has been shown to shrink tumours in several tumour models. The study will evaluate the efficacy as well as the toxicity profile of anlotinib when used as an alternative treatment for participants with PPGL tumours.

Conditions

  • Advanced or Metastatic Paraganglioma/ Pheochromocytoma

Interventions

DRUG

Anlotinib

Anlotinib 12mg capsules given orally on once daily in 21-day cycle until disease progression or treatment intolerance(14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21), the dose can be adjusted to 10mg or 8mg according to the specific conditions of the patient.

Sponsors & Collaborators

  • Nanjing First Hospital, Nanjing Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-14
Primary Completion
2023-09-14
Completion
2023-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05133349 on ClinicalTrials.gov