Unresectable locally advanced or metastatic medullary thyroid cancer MedDRA version: 14.1 Level: LLT Classification code 10027105 Term: Medullary thyroid cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Written consent from Female or male patients aged 18 years and over. Previously confirmed histological diagnosis of unresectable, locally advanced or metastatic, hereditary or sporadic MTC Objective disease progression within the previous 14 months prior to enrolment, and/or have one or more symptoms that the Investigator believes to be related to the patient’s MTC. World Health Organisation (WHO) or Eastern Cooperative Oncology Group (ECOG) Performance status 0-2. Has measurable disease (at least one lesion, not irradiated within12 weeks of study randomisation, with longest diameter =10mm (lymph nodes minimum =15 mm) with CT or MRI). Lesions must be amenable to accurate and repeat measurement. 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 63 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 17
Exclusion criteria
Exclusion criteria: Prior treatment (major surgery, radiation therapy, chemotherapy, or other investigational drugs) received within 28 days before randomization. Abnormal liver function tests (bilirubin>1.5xULRR, and ALT, AST, or ALP>2.5xULRR or 5.0xULRR if related to liver metastases). Significant cardiac conditions or events such as reduced cardiac functions, symptomatic cardiac arrhythmia requiring treatment, congenital long QT syndrome, history of drug-induced QT prolongation, or QTcF correction unmeasurable or >450 ms Abnormal electrolytes such as potassium, magnesium and calcium, or abnormal organ functions such as decreased creatinine clearance. For women only - currently pregnant or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the objective response rates (ORR) for 150 mg and 300 mg/day of vandetanib in patients with advanced & progressive MTC. ORR = % of patients with a best response of complete or partial response (CR/PR) as per RECIST Version1.1;Secondary Objective: Safety, tolerability and pharmacokinetics of vandetanib 150 mg and 300 mg. Time to and duration of objective response, and best percentage change in target lesion size in Part A. Examine the relationship between PK and QTc ;Primary end point(s): To assess the objective response rates (ORR) for 150 mg and 300 mg/day of vandetanib in patients with advanced & progressive MTC. ORR = % of patients with a best response of complete or partial response (CR/PR) as per RECIST Version1.1;Timepoint(s) of evaluation of this end point: Patient's disease status is measured every 12 weeks for up to14months after start of treatment or objective disease progression if earlier. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the safety and tolerability of vandetanib 150 mg and 300 mg To evaluate the time to objective response, duration of objective response, and the best percentage change in target lesion (TL) size while in Part A of the study To evaluate the pharmacokinetics (PK) of vandetanib at 150 mg and 300 mg in this patient population To examine the relationship between PK and QTcF (QT interval corrected for heart rate according to Fridericia)is applicable;Timepoint(s) of evaluation of this end point: Safety monitored continuously and evaluated after 14 and 24 months. NB treatment is unblinded after 14 months or objective progression Disease levels evaluated for 14months after start of treatment or objective disease progression if earlier.NB treatment is unblinded after 14 months or objective progression At 3, 8, 12, 24 and 60 weeks after starting treatment and when objective disease progession is evident (if <60 weeks) Safety monitored continuously and evaluated overall after 14 and 24 months. NB treatment is unblinded after 14 months or objective progression | — |
Countries
Czech Republic, India, Israel, Italy, Netherlands, Poland, Russian Federation, United Kingdom, United States
Contacts
Public ContactInformation Centre
AstraZeneca
Outcome results
None listed