A phase II study exploring the safety and efficacy of nintedanib (BIBF1120) as second line therapy for patients with either differentiated or medullary thyroid cancer progressing after first line therapy. - EORTC protocol 1209-EnTF

European Organisation for Research and Treatment of Cancer. EORTC0 sites102 target enrollmentJuly 10, 2014

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Histologically confirmed differentiated or medullary thyroid cancer by local pathologist.
Sponsor: European Organisation for Research and Treatment of Cancer. EORTC
Enrollment: 102
Status: Active, not recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

July 10, 2014

End Date

August 28, 2019

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

European Organisation for Research and Treatment of Cancer. EORTC

•? Histologically confirmed differentiated or medullary thyroid cancer by local pathologist.
•? Available tumor tissue at the time of initial diagnosis for histology review.
•? Locally advanced or metastatic disease deemed incurable by surgery, radiotherapy and/or radioactive iodine (RAI).
•? Patients must have measurable lesion with documented progression during the 12 months prior to randomization.
•? Patients must have received one or 2 prior line of treatment (but no more than two) and must be off treatment for at least 4 weeks prior to randomization.
•? Age \=18 years.
•? Performance status (PS) 0\-1 (WHO, Appendix C).
•? Life expectancy of more than 12 weeks.
•? Adequate organ function, evidenced by the following laboratory results within 3 weeks prior to randomization
•Are the trial subjects under 18? no

•? Current symptomatic brain metastases or if previously present, must have been treated at least two months before randomization.
•? History of other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or basal cell or spinocellular carcinoma of the skin.
•? Ongoing treatment related toxicity due to prior treatment \> grade I (except alopecia).
•? History of significant cardiac disease
•? Current uncontrolled hypertension
•? Evidence of active bleeding or bleeding diathesis.
•? Cerebrovascular accident at any time in the past, transient ischemic attack, deep venous thrombosis (DVT) or pulmonary embolism in the past 6 months
•? History of clinically significant gastrointestinal disorders .
•? Current severe, uncontrolled systemic disease or any other systemic disease/symptom that can hamper compliance with the protocol.
•? Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery.