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
- Conditions
- Histologically confirmed differentiated or medullary thyroid cancer by local pathologist.MedDRA version: 16.0Level: PTClassification code 10027105Term: Medullary thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0Level: PTClassification code 10066474Term: Thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0Level: PTClassification code 10033701Term: Papillary thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-004295-19-IT
- Lead Sponsor
- European Organisation for Research and Treatment of Cancer. EORTC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 102
? 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
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 105
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45
? 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to explore the efficacy of nintedanib (as measured by progression free survival) as second line therapy for patients with either differentiated or medullary thyroid cancer progressing after first line therapy.;Secondary Objective: ? To explore the safety of nintedanib as second line treatment in patients with MTC or DTC.<br><br>? To explore the molecular mechanisms of action of the drug.;Primary end point(s): ? Progression free survival (RECIST 1.1);Timepoint(s) of evaluation of this end point: Patients be followed every 8 weeks until progression for the endpoints of the trial
- Secondary Outcome Measures
Name Time Method Secondary end point(s): ? Response Rate (RECIST 1.1)<br>? Toxicity profile<br>? Duration of response<br>? Exploration of the molecular mechanisms of action of drug;Timepoint(s) of evaluation of this end point: Patients be followed every 8 weeks until progression for the endpoints of the trial