Efficacy and Safety Study of Sorafenib to Treat Advanced Medullary Thyroid Carcinoma (SUMMIT)
This study has been withdrawn prior to enrollment.
(Study was withdrawn due to unanticipated hassle in patient recruitment.)
Sponsor:
Eanm Research Ltd
Information provided by (Responsible Party):
Eanm Research Ltd
ClinicalTrials.gov Identifier:
NCT01736878
First received: October 23, 2012
Last updated: May 16, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Medullary Thyroid Carcinoma |
Drug: Sorafenib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized Double-blind Placebo Controlled Phase II Study to Evaluate the Efficacy and Safety of Sorafenib Treatment in Patients With Advanced (Recurrent, Persistent and/or Metastasizing) Medullary Thyroid Carcinoma |
Resource links provided by NLM:
Further study details as provided by Eanm Research Ltd:
Primary Outcome Measures:
- Progression Free Survival (PFS) [ Time Frame: from the date of randomisation until the date of radiological or biochemical progression or death. An average of 9 months is assumed. ] [ Designated as safety issue: No ]The proportion of patients with PFS in the Sorafenib group and the Placebo group will be compared by log rank test and Kaplan-Meier plot.
Secondary Outcome Measures:
- Time to Progression (TPP) [ Time Frame: from the date of randomisation until the date of confirmed radiological or biochemical progression. An average of 9 months is assumed. ] [ Designated as safety issue: No ]The average TTP in the Sorafenib group and the Placebo group will be compared.
Other Outcome Measures:
- Overall Survival (OS) [ Time Frame: from the date of randomisation until the date of death due to any cause. Final assessment at the end of study after approximately 36 months. ] [ Designated as safety issue: No ]The proportion of surviving patients in the Sorafenib group and the Placebo group will be compared.
| Enrollment: | 0 |
| Study Start Date: | October 2012 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sorafenib tablets
Oral administration of Sorafenib tablets, 400 mg bid, until disease progression or unacceptable toxicity
|
Drug: Sorafenib |
|
Placebo Comparator: Placebo tablets
Oral administration of Placebo tablets until disease progression, afterwards continuation with Sorafenib at the discretion of the investigator
|
Drug: Sorafenib |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Eanm Research Ltd |
| ClinicalTrials.gov Identifier: | NCT01736878 History of Changes |
| Other Study ID Numbers: | EARL-2, 2011-006250-90 |
| Study First Received: | October 23, 2012 |
| Last Updated: | May 16, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices Austria : Federal Ministry for Labour, Health, and Social Affairs |
Keywords provided by Eanm Research Ltd:
|
Medullary Thyroid Carcinoma Sorafenib Efficacy |
Additional relevant MeSH terms:
|
Carcinoma Thyroid Neoplasms Thyroid Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Head and Neck Neoplasms |
Endocrine System Diseases Sorafenib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013