3-arm Trial to Evaluate Pasireotide LAR/Everolimus Alone/in Combination in Patients With Lung/Thymus NET - LUNA Trial
This study is not yet open for participant recruitment.
Verified April 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01563354
First received: March 20, 2012
Last updated: April 10, 2013
Last verified: April 2013
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Purpose
The purpose of this study is to test the effectiveness and safety of everolimus or pasireotide LAR alone or in combination in patients with your disease.
More specifically, this study aims to find out if the study drugs everolimus or pasireotide LAR alone or in combination (LAR stands for long-acting release) are safe and have beneficial effects in patients who have a neuroendocrine carcinoma of the lung and thymus. The studied treatment aims to shrink tumor size or stop the progression of your disease. The assessment will be based on measuring changes in the size of the tumor.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroendocrine Carcinoma of the Lung and Thymus |
Drug: Pasireotide LAR Drug: Everolimus Drug: Pasireotide LAR + Everolimus |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multicenter 3-arm Trial to Evaluate the Efficacy and Safety of Pasireotide LAR or Everolimus Alone or in Combination in Patients With Well Differentiated Neuroendocrine Carcinoma of the Lung and Thymus - LUNA Trial |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Proportion of patients progression-free at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free survival [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]Time from first study drug administration to objective tumor progression or death from any cause
- Disease control rate [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]Proportion of patients showing a best overall response of complete response, partial response or stable disease during 12 months of treatment
- Time to response [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]Time from start of treatment to the first observed objective tumor response (partial response or complete response)
- Duration of response [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]Time from onset of the first objective tumor response (partial response or complete response) to objective tumor progression or death from any cause
- Time to progression [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]Time from date of start of treatment to date of event defined as the first documented progression or death due to underling disease.
- Biochemical response rate [ Time Frame: Every 3 months up to Year 1 ] [ Designated as safety issue: No ]Percentage of patients showing normalization or a decrease > or = 50% of serum CgA, urinary 5HIAA
- Rate and severity of adverse events [ Time Frame: Week 2, 3 and 4; every month up to Year 3 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 112 |
| Study Start Date: | June 2013 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pasireotide LAR
60 mg i.m. injected once every 28 days
|
Drug: Pasireotide LAR
60 mg i.m. injected once every 28 days
|
|
Experimental: Everolimus
10 mg p.o. daily
|
Drug: Everolimus
10 mg p.o. daily
|
|
Experimental: Pasireotide LAR + Everolimus
Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily
|
Drug: Pasireotide LAR + Everolimus
Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 Performance Status 0-2
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 inclusion/exclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563354
Contacts
| Contact: Novartis Pharmaceuticals | +41613241111 | |
| Contact: Novartis Pharmaceuticals |
Locations
| Denmark | |
| Novartis Investigative Site | Not yet recruiting |
| Aarhus, Denmark, 8000 C | |
| Novartis Investigative Site | Not yet recruiting |
| Copenhagen, Denmark, DK-2100 | |
| France | |
| Novartis Investigative Site | Not yet recruiting |
| LILLE Cedex, France, 59037 | |
| Novartis Investigative Site | Not yet recruiting |
| Lyon, France, 69437 | |
| Novartis Investigative Site | Not yet recruiting |
| Marseille cedex 20, France, 13915 | |
| Novartis Investigative Site | Not yet recruiting |
| Rennes, France, F-35043 | |
| Novartis Investigative Site | Not yet recruiting |
| Strasbourg Cedex, France, 67091 | |
| Novartis Investigative Site | Not yet recruiting |
| Toulouse Cedex 9, France, 31059 | |
| Novartis Investigative Site | Not yet recruiting |
| Villejuif Cedex, France, 94805 | |
| Italy | |
| Novartis Investigative Site | Not yet recruiting |
| Ancona, AN, Italy, 60126 | |
| Novartis Investigative Site | Not yet recruiting |
| Avellino, AV, Italy, 83100 | |
| Novartis Investigative Site | Not yet recruiting |
| Viagrande, CT, Italy, 95029 | |
| Novartis Investigative Site | Not yet recruiting |
| Milano, MI, Italy, 20141 | |
| Novartis Investigative Site | Not yet recruiting |
| Padova, PD, Italy, 35100 | |
| Novartis Investigative Site | Not yet recruiting |
| Perugia, PG, Italy, 06129 | |
| Novartis Investigative Site | Not yet recruiting |
| Parma, PR, Italy, 43100 | |
| Novartis Investigative Site | Not yet recruiting |
| Roma, RM, Italy, 00128 | |
| Novartis Investigative Site | Not yet recruiting |
| Orbassano, TO, Italy, 10043 | |
| Novartis Investigative Site | Not yet recruiting |
| Napoli, Italy, 80131 | |
| Spain | |
| Novartis Investigative Site | Not yet recruiting |
| Cordoba, Andalucia, Spain, 14004 | |
| Novartis Investigative Site | Not yet recruiting |
| Granada, Andalucía, Spain, 18014 | |
| Novartis Investigative Site | Not yet recruiting |
| Sevilla, Andalucía, Spain, 41013 | |
| Novartis Investigative Site | Not yet recruiting |
| Barcelona, Cataluna, Spain, 08025 | |
| Novartis Investigative Site | Not yet recruiting |
| Valencia, Comunidad Valenciana, Spain, 46014 | |
| Novartis Investigative Site | Not yet recruiting |
| Madrid, Spain, 28046 | |
| Sweden | |
| Novartis Investigative Site | Not yet recruiting |
| Lund, Sweden, SE-221 85 | |
| Novartis Investigative Site | Not yet recruiting |
| Uppsala, Sweden, SE-751 85 | |
| Switzerland | |
| Novartis Investigative Site | Not yet recruiting |
| St. Gallen, Switzerland, 9007 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01563354 History of Changes |
| Other Study ID Numbers: | CSOM230DIC03, 2011-002872-17 |
| Study First Received: | March 20, 2012 |
| Last Updated: | April 10, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
neuroendocrine carcinoma; lung; thymus; pasireotide LAR; everolimus |
Additional relevant MeSH terms:
|
Carcinoma Lung Neoplasms Carcinoma, Neuroendocrine Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Adenocarcinoma Neoplasms, Nerve Tissue Everolimus Sirolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on June 17, 2013