To evaluate the efficacy of pasireotide LAR and everolimus alone or in combination in progressive patients with a well differentiated neuroendocrine tumor of the lung or thymus.
ID
Source
Brief title
Condition
- Neoplastic and ectopic endocrinopathies
- Endocrine neoplasms malignant and unspecified
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is defined as the proportion of patients progression-free
at 9 months according to RECIST 1.1.
Secondary outcome
* Overall progression-free survival
* Time to response, duration of response and time to progression, objective
response rate and best response
* Biochemical response rate, duration of biochemical response and biochemical
progression free survival
* Rate and severity of AEs
Background summary
This study is based on both preclinical and clinical considerations:
* Combined inhibition of the IGF-1-, the PI3K- and the mTOR-pathways by
pasireotide and everolimus may control tumor growth more effectively than
either compound alone.
* Combination of everolimus with sandostatin LAR seems to improve progression
free survival in NET patients. Thus the combination of everolimus with
pasireotide LAR might result in even better tumor control.
The purpose of this study is to assess efficacy and safety of pasireotide LAR
and everolimus alone or in combination.
Study objective
To evaluate the efficacy of pasireotide LAR and everolimus alone or in
combination in progressive patients with a well differentiated neuroendocrine
tumor of the lung or thymus.
Study design
A prospective, multicenter, randomized, open-label, 3-arm, phase II study with
a single-stage design in each arm to evaluate the efficacy and safety of
pasireotide LAR (SOM230) and everolimus (RAD001) alone or in combination in the
treatment of patients with a well differentiated neuroendocrine carcinoma of
lung or thymus.
Intervention
Arm 1 treatment with pasireotide (SOM230) LAR (60 mg/month i.m.),
Arm 2 treatment with everolimus (RAD001) (10 mg/day p.o.),
Arm 3 treatment with pasireotide LAR (60 mg/month i.m.) and everolimus (10
mg/day p.o.)
Study burden and risks
* Possible toxicity of treatment by pasireotide LAR and everolimus, alone or in
combination. Side effects are specified in appendix D of the patient
information.
* The study assessments are common medical assessments: blood sampling,
echocardiogram (using ultrasound) or MUGA scan (using radiation), CT-scan
(using radiation) or MRI. An overview of all study procedures can be found in
appendix B of the patient information.
* Frequent study visits
It is not certain that the patient will benefit from the study participation.
However, obtained insights might be useful in the future. The extent of the
burden to the patient are as to be expected from a phase II study.
Raapopseweg 1
Arnhem 6824 DP
NL
Raapopseweg 1
Arnhem 6824 DP
NL
Listed location countries
Age
Inclusion criteria
* Histological confirmed advanced well differentiated carcinoma of the lung and thymus;* Patients of all treatment lines can be included;* At least one measurable lesion of disease on CT scan or MRI;* Radiological documentation of disease progression within 12 months prior to randomization;* Adequate liver, renal and bone marrow function;* WHO performancestatus 0-2;Other protocol-defined inclusion criteria may apply
Exclusion criteria
* Poorly differentiated neuroendocrine carcinoma;* Non-neuroendocrine thymoma;* Patients with severe functional disease requiring symptomatic treatment with somatostatin analogs;* Prior therapy with mTOR inhibitors;* History of liver disease;* Baseline QTcF> 470 msec;* Uncontrolled diabetes mellitus despite adequate therapy;Other protocol-defined exclusion criteria may apply
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-002872-17-NL |
| ClinicalTrials.gov | NCT01563354 |
| CCMO | NL44585.031.13 |