A phase II study exploring the safety and efficacy of nintedanib (BIBF1120) as second line therapy for patients with eitherc differentiated and medullary thyroid carcinoma progressing after first line therapy.
- Conditions
- thyroid cancerthyroid carcinoma10043739
- Registration Number
- NL-OMON47685
- Lead Sponsor
- European Organisation for Research in Treatment of Cancer (EORTC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
* 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. Patients with an MTC 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. If it is available and reimbursed in the respective country one of the prior lines of treatment needs to be with Vandetanib as long as there is no contraindication or the patient refuses the treatment with Vandetanib.
* 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
* 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.
* History of receiving any investigational treatment within 28 days prior
to randomization
* Women or patients of child bearing potential who do not use any
contraceptive methods
* Any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up
schedule.
* No hypersensitivity to nintedanib, peanut or soya, or to any of the excipients of nintedanib.
* Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 3 months after the last dose of study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
* Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until at least 3 months after the last dose of study treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* Progression free survival (RECIST 1.1)</p><br>
- Secondary Outcome Measures
Name Time Method <p>* Secondary end-points<br /><br>* Response Rate (RECIST 1.1)<br /><br>* Duration of response<br /><br>* Exploration of the molecular mechanisms of action of drug<br /><br>* PFS at second progression (PFS-2) for patients crossing over from placebo to<br /><br>nintedanib.<br /><br><br /><br>Safety<br /><br>* Toxicity profile (CTCAE version 4.0 will be used for adverse event reporting)</p><br>