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Safety and Efficacy of RAD001 in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor (\MACS1304)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01324492
Recruitment Status : Completed
First Posted : March 29, 2011
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The present study is designed to collect safety/tolerability data and explore the efficacy of RAD001 in advanced pulmonary neuroendocrine tumor in Chinese patients.

Condition or disease Intervention/treatment Phase
Lung Neuroendocrine Neoplasm Drug: RAD001 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib, Open-label Study to Evaluate RAD001 as Monotherapy Treatment in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor
Study Start Date : December 2010
Primary Completion Date : June 2014
Study Completion Date : June 2014


Arm Intervention/treatment
Experimental: RAD001 Drug: RAD001
Other Name: Everolimus



Primary Outcome Measures :
  1. Adverse events, serious adverse events, laboratory results (Hematology, Serum Blood Chemistry, hepatitis tests, Standard urinalysis dipstick assessment, Coagulation Studies)or assessment of the incidence of pneumonitis [ Time Frame: every 6 weeks ]

Secondary Outcome Measures :
  1. Chest X-Ray,Triphasic CT scan or MRI of the chest, abdomen and cavitas pelvis evaluated by using RECIST criteria [ Time Frame: 6 weeks ]
  2. Date and reason of death, or discontinuation from the study. [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed carcinoid tumors
  • Newly diagnosed advanced carcinoid tumors or progressed after 1st line treatment is eligible

Exclusion Criteria:

  • Patients with either clinically apparent central nervous system metastases or carcinomatous meningitis(non-clinical symptoms with brain lesions is eligible)
  • Received Cytotoxic chemotherapy, immunotherapy or radiotherapy prior to enrollment
  • Patients with a concurrent malignancy, or history of prior malignancy within the past three years, except for basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, treated early stage (T1a) prostate cancer or treated early stage (DCIS or LCIS) breast cancer
  • Prior therapy with RAD001 or other mTOR inhibitors (sirolimus, temsirolimus, everolimus)

Other protocol-defined inclusion/exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01324492


Locations
China, Beijing
Novartis Investigative Site
Beijing, Beijing, China, 100730
China, Guangdong
Novartis Investigative Site
Guangzhou, Guangdong, China, 510030
China, Jilin
Novartis Investigative Site
Changchun, Jilin, China
China, Liaoning
Novartis Investigative Site
Shenyang, Liaoning, China
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Investigative Site

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01324492     History of Changes
Other Study ID Numbers: CRAD001KCN01
First Posted: March 29, 2011    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
phase Ib,
RAD001,
advanced pulmonary neuroendocrine tumor

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents