NCT02623127

Brief Summary

This study aims to investigate the clinical activity of sunitinib in patients with advanced thymic carcinoma who have failed chemotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 7, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

2.2 years

First QC Date

October 28, 2015

Last Update Submit

January 18, 2019

Conditions

Thymic Carcinoma

Keywords

Thymic carcinomaSunitinibMetastaticRecurrent

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    CR or PR by RECIST criteria version 1.1

    Up to 6 months

Secondary Outcomes (4)

  • Disease control rate

    Up to 6 months

  • Progression-Free Survival

    Up to 6 months

  • Overall survival

    From first day of study treatment to day of any kind of death, assessed up to 24 months

  • Incidence of treatment related adverse events [Safety and Tolerability]

    Up to 6 months

Other Outcomes (1)

  • Biomarker endpoint

    Day 1

Study Arms (1)

Sunitinib

EXPERIMENTAL

Sunitinib will be administered orally at a dose of 50 mg once daily in 3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment.

Drug: Sunitinib

Interventions

SunitinibDRUG
Sunitinib

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of signed, written and dated informed consent prior to any study specific procedures
  • Histopathologically confirmed metastatic or recurrent thymic thymic carcinoma
  • Age ≥ 20
  • ECOG PS 0-2
  • Documented progressive disease after one or more conventional systemic chemotherapy
  • At least one measurable disease by RECIST v1.1
  • Adequate organ function for treatment as follows:
  • Absolute neutrophil count \> 1.5 x 109/L
  • Platelets \>100 x 109/L
  • Serum creatinine ≤ 2.0 x ULN (upper limit of normal)
  • Serum bilirubin ≤ 1.5 x ULN
  • AST and ALT ≤ 2.5 x ULN (without liver metastasis), ≤ 5.0 x ULN (with liver metastasis)
  • Life expectancy ≥ 12 weeks at day 1

You may not qualify if:

  • Previous treatment with sunitinib or other VEGF-TKIs
  • Any major operation or irradiation within 4 weeks of baseline disease assessment
  • Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug
  • CNS metastasis with continuous corticosteroid use within 4 weeks of baseline disease assessment (Asymptomatic CNS metastasis patients can be enrolled)
  • Patients with uncontrolled or significant cardiovascular disease (AMI within 12 months, Unstable angina within 6 months, NYHA Class III, IV Congestive heart failure or left ventricular ejection fraction below local institutional lower limit of normal or below 45%, Congenital long QT syndrome, Any significant ventricular arrhythmia, Any uncontrolled second or third degree heart block, Uncontrolled hypertension)
  • Concomitant malignancy (except adequately treated basal cell cancer of skin or cervical cancer in situ)
  • Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
  • Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into this trial. (including active bleeding, untreated DVT or thromboembolism)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, 463-707, South Korea

Location

Related Links

MeSH Terms

Conditions

ThymomaNeoplasm MetastasisRecurrence

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Neoplasms, Complex and MixedNeoplasms by Histologic TypeNeoplasmsThymus NeoplasmsThoracic NeoplasmsNeoplasms by SiteLymphatic DiseasesHemic and Lymphatic DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Jong Seok Lee, MD, PhD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Internal Medicine

Study Record Dates

First Submitted

October 28, 2015

First Posted

December 7, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2017

Study Completion

October 1, 2018

Last Updated

January 23, 2019

Record last verified: 2019-01

Locations

KR(1)