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A phase II study of second line therapy on safety and efficacy of nintedanib for patients with either differentiated or medullary thyroid cancer progressing after first line therapy.

Phase 1
Conditions
Histologically confirmed differentiated or medullary thyroid cancer by local pathologist.
MedDRA version: 21.1Level: PTClassification code 10027105Term: Medullary thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 21.1Level: PTClassification code 10066474Term: Thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 21.1Level: 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-PL
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
Inclusion Criteria

? 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

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 1
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

? 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.
? Hypersensitivity to nintedanib, peanut or soya, or to any of the excipients of nintedanib.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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.<br><br>? To explore other measure of activity/efficacy i.e. overall survival, duration of response, PFS at second progression (PFS-2) for patients crossing over from placebo to nintedanib.;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
NameTimeMethod
Secondary end point(s): ? Response Rate (RECIST 1.1)<br>? Duration of response<br>? Exploration of the molecular mechanisms of action of drug<br>? PFS at second progression (PFS-2) for patients crossing over from placebo to nintedanib.<br>? Toxicity profile (CTCAE version 4.0 will be used for adverse event reporting)<br>;Timepoint(s) of evaluation of this end point: Patients be followed every 8 weeks until progression for the endpoints of the trial
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