Efficacy and Safety Study of Sorafenib to Treat Advanced Medullary Thyroid Carcinoma (SUMMIT)

Eanm Research

Status and phase

Withdrawn

Phase 2

Conditions

Medullary Thyroid Carcinoma

Treatments

Drug: Sorafenib

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT01736878

2011-006250-90 (EudraCT Number)

EARL-2

Details and patient eligibility

About

The purpose of his study is to evaluate the efficacy and safety of Sorafenib versus placebo in subjects with locally advanced medullary thyroid cancer (MTC). The primary study objective is to compare the Progression-free Survival (PFS) of the Sorafenib treatment group with the placebo treatment group in patients with advanced MTC.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Inpatient or outpatient ≥ 18 years of age
Histologically confirmed medullary thyroid carcinoma
Recurrent or persistent local disease and/or distant metastases
No more than one prior line of systemic therapy
Best available supportive care to control (endocrine) symptoms
At least one defined lesion in CT or MRI evaluable for Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or at least one defined lesion in CT or MRI not evaluable by RECIST in combination with elevated tumour markers
Progression within previous 12 months
Hb > 8g/dl, white blood cells (WBC) >3.000 cells/mm³ (ANC > 1.500 cells/mm³), platelets > 100.000 cells/mm³, bilirubin < 2mg/dl, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN)
Performance status: WHO ≤ 2; Karnofsky index ≥ 50%
Sufficient renal function (creatinin <1.5 mg/dl and creatinin clearance > 30ml/min)
International normalized ratio (INR) and partial thromboplastin time (PTT) < 1.5 x ULN
No acute infections
Staging studies (MRT or CT and Calcitonin or CEA) completed within four weeks of protocol randomisation
Women of childbearing potential with negative serum pregnancy test
Women and men of childbearing potential using adequate contraception
Signed and dated written informed consent

Exclusion criteria

Unresolved toxicity (i.e. neurotoxicity) attributed to any prior therapy higher than National Cancer Institute-Common Toxicity Criteria for Adverse Effects (NCI-CTCAE version 4) Grade 2 (excluding cases of alopecia)
Patients with history of allergic or hypersensitivity reaction to study drug or placebo or their excipients
Current participation in another investigational trial
Patients with significant cardiovascular disease
Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy other than beta-blockers or digoxin
Congenital long corrected QT interval (QTc) syndrome, history of drug induced QTc prolongation, or QTc interval unmeasurable or more than 450 ms
Abnormal serum electrolytes such as potassium, magnesium and calcium
Uncontrolled hypertension, despite optimal management
Major surgery, open biopsy, or significant traumatic injury within 30 days prior to randomization
Non-healing wound, ulcer, or bone fracture
Evidence or history of bleeding diathesis or coagulopathy disorder
Hemorrhage/bleeding event ≥ Grade 3
Thrombotic or embolic events including transient ischemic attacks within the past 6 months
Subjects with symptomatic brain metastases or Subjects with brain metastases under corticosteroid treatment
Pregnant or breast-feeding patients
Patients with uncontrolled infections
Known HIV infection or infection with hepatitis B or C
Immunosuppression
Subjects with seizure disorder requiring medication • Subjects undergoing renal dialysis
Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
Any malabsorption condition