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A Study of Sunitinib in Patients With Metastatic or Recurrent Thymic Carcinoma (KOSMIC)

Primary Purpose

Thymic Carcinoma

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Sunitinib

About this trial

This is an interventional treatment trial for Thymic Carcinoma focused on measuring Thymic carcinoma, Sunitinib, Metastatic, Recurrent

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)

Sites / Locations

Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sunitinib

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective response rate

CR or PR by RECIST criteria version 1.1

Secondary Outcome Measures

Disease control rate

CR or PR or SD by RECIST criteria version 1.1

Progression-Free Survival

Overall survival

Incidence of treatment related adverse events [Safety and Tolerability]

Number of patients with adverse events during cycle 1 (each cycle is 21 days). Subjects will be evaluated for toxicity according to NCI-CTCAE(Common Terminology Criteria for Adverse Events) of version 4.0.

Full Information

NCT ID

NCT02623127

First Posted

October 28, 2015

Last Updated

January 18, 2019

Sponsor

Seoul National University Hospital

Collaborators

SMG-SNU Boramae Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02623127

Brief Title

A Study of Sunitinib in Patients With Metastatic or Recurrent Thymic Carcinoma

Acronym

KOSMIC

Official Title

A Phase II, Non-comparative, Open Label, Multi-center Study of Sunitinib in Patients With Metastatic or Recurrent Thymic Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

October 2015 (Actual)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

Collaborators

SMG-SNU Boramae Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

Sunitinib (Sutent®; Pfizer, New York, NY, USA) is a multitargeted tyrosine-kinase inhibitor (TKI) with activity against the stem cell-factor receptor (KIT) and platelet-derived growth-factor receptor (PDGFR), vascular endothelial growth-factor receptor (VEGFR), glial cell line-derived neurotrophic factor receptor (rearranged during transfection [RET]), colony-stimulating factor-1 receptor (CSF1R), and Fms-like tyrosine kinase-3 receptor (FLT3). Sunitinib is a potent inhibitor of mutant KIT with additional inhibitory effects on VEGF receptors that potentially might make it more effective than imatinib against TCs. In the current version of NCCN guideline, sunitinib is suggested as one of the potential targeted therapeutics for advanced TCs. We planned this study to investigate the clinical efficacy and tolerability of sunitinib in patients with advanced or recurrent TCs in Korean population. In addition, we will collect tumor samples and blood samples from patients for the further exploration of predictive biomarkers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thymic Carcinoma

Keywords

Thymic carcinoma, Sunitinib, Metastatic, Recurrent

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sunitinib

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Sunitinib

Primary Outcome Measure Information:

Title

Objective response rate

Description

CR or PR by RECIST criteria version 1.1

Time Frame

Up to 6 months

Secondary Outcome Measure Information:

Title

Disease control rate

Description

CR or PR or SD by RECIST criteria version 1.1

Time Frame

Up to 6 months

Title

Progression-Free Survival

Time Frame

Up to 6 months

Title

Overall survival

Time Frame

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

Title

Incidence of treatment related adverse events [Safety and Tolerability]

Description

Time Frame

Up to 6 months

Other Pre-specified Outcome Measures:

Title

Biomarker endpoint

Description

When available, banked tumor tissue for genomic analysis for predictive biomarker of sunitinib.

Time Frame

Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jong Seok Lee, MD, PhD

Organizational Affiliation

Seoul National University Bundang Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Bundang Hospital

City

Seongnam

ZIP/Postal Code

463-707

Country

Korea, Republic of

12. IPD Sharing Statement

Links:

URL

https://doi.org/10.1016/j.jtho.2018.08.297

Description

Oral Presentation at WCLC 2018 (OA11.05 )

Learn more about this trial

A Study of Sunitinib in Patients With Metastatic or Recurrent Thymic Carcinoma

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