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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02623127
Recruitment Status : Completed
First Posted : December 7, 2015
Last Update Posted : January 23, 2019
Sponsor:
Collaborator:
SMG-SNU Boramae Medical Center
Information provided by (Responsible Party):
Jong-Seok Lee, Seoul National University Bundang Hospital

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

Condition or disease Intervention/treatment Phase
Thymic Carcinoma Drug: Sunitinib Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Non-comparative, Open Label, Multi-center Study of Sunitinib in Patients With Metastatic or Recurrent Thymic Carcinoma
Actual Study Start Date : October 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : October 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Sunitinib
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


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate [ Time Frame: Up to 6 months ]
    CR or PR by RECIST criteria version 1.1


Secondary Outcome Measures :
  1. Disease control rate [ Time Frame: Up to 6 months ]
    CR or PR or SD by RECIST criteria version 1.1

  2. Progression-Free Survival [ Time Frame: Up to 6 months ]
  3. Overall survival [ Time Frame: From first day of study treatment to day of any kind of death, assessed up to 24 months ]
  4. Incidence of treatment related adverse events [Safety and Tolerability] [ Time Frame: Up to 6 months ]
    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.


Other Outcome Measures:
  1. Biomarker endpoint [ Time Frame: Day 1 ]
    When available, banked tumor tissue for genomic analysis for predictive biomarker of sunitinib.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of signed, written and dated informed consent prior to any study specific procedures
  2. Histopathologically confirmed metastatic or recurrent thymic thymic carcinoma
  3. Age ≥ 20
  4. ECOG PS 0-2
  5. Documented progressive disease after one or more conventional systemic chemotherapy
  6. At least one measurable disease by RECIST v1.1

  7. 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)
  8. Life expectancy ≥ 12 weeks at day 1

Exclusion Criteria:

  1. Previous treatment with sunitinib or other VEGF-TKIs
  2. Any major operation or irradiation within 4 weeks of baseline disease assessment
  3. Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug
  4. CNS metastasis with continuous corticosteroid use within 4 weeks of baseline disease assessment (Asymptomatic CNS metastasis patients can be enrolled)
  5. 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)
  6. Concomitant malignancy (except adequately treated basal cell cancer of skin or cervical cancer in situ)
  7. 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
  8. 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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02623127


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
SMG-SNU Boramae Medical Center
Investigators
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Principal Investigator: Jong Seok Lee, MD, PhD Seoul National University Bundang Hospital
More Information
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Additional Information:

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Responsible Party: Jong-Seok Lee, Professor of Internal Medicine, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02623127    
Other Study ID Numbers: SNUBH-15-01
First Posted: December 7, 2015    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Keywords provided by Jong-Seok Lee, Seoul National University Bundang Hospital:
Thymic carcinoma
Sunitinib
Metastatic
Recurrent
Additional relevant MeSH terms:
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Carcinoma
Thymoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Complex and Mixed
Thymus Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases
 Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action