Phase 4
N=81
To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer
Thyroid Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01496313 ↗Enrolled (actual)
81
Serious AEs
24.7%
Results posted
Nov 2015
Primary outcome: Primary: Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator — 0.20; 0.29 Proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 300mg vandetanib (Drug); 150mg vandetanib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator |
0.20; 0.29 | — |
| SECONDARY Best Objective Response |
0; 1; 8; 11; 21; 23 | — |
| SECONDARY Duration of Objective Response (RECIST 1.1) by Treatment Arm |
9.8; 8.4 | — |
| SECONDARY Time to Objective Response (RECIST 1.1) by Treatment Arm |
4.2; 4.4 | — |
| SECONDARY Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm |
-3.8; -17.5; -13.0; -24.9; -16.7; -29.1 | — |
| SECONDARY Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm. |
428.6; 786.2; 510.5; 941.0; 561.4; 969.9 | — |
Summary
The purpose of this study is to give patients with medullary thyroid cancer either 300mg/day or 150mg/day vandetanib and compare how well each dose affects how their cancer responds. It will also help the investigators understand the side effects of different doses in these patients.
Eligibility 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 within 12 weeks of study randomisation, with longest diameter more or equal 10mm (lymph nodes minimum more or equal 15 mm) with CT or MRI).
- Lesions must be amenable to accurate and repeat measurement.
Exclusion Criteria
- Prior treatment (major surgery, radiation therapy, chemotherapy, or other investigational drugs) received within 28 days before randomization.
- Abnormal liver function tests (bilirubin more than 1.5xULRR, and ALT, AST, or ALP more than 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 more than 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.
Data sourced from ClinicalTrials.gov (NCT01496313). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.