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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01324492
First received: March 24, 2011
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Lung Neuroendocrine Neoplasm
Drug: RAD001
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Chest X-Ray,Triphasic CT scan or MRI of the chest, abdomen and cavitas pelvis evaluated by using RECIST criteria [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Date and reason of death, or discontinuation from the study. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RAD001 Drug: RAD001
Other Name: Everolimus

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01324492

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

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

No publications provided

Responsible Party: Clinical Disclosure Office, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01324492     History of Changes
Other Study ID Numbers: CRAD001KCN01
Study First Received: March 24, 2011
Last Updated: June 5, 2014
Health Authority: United States: Food and Drug Administration
China: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 27, 2014