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Safety of RAD001 in Chinese Patients With Metastatic Renal Cell Cancer

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ClinicalTrials.gov Identifier: NCT01152801
Recruitment Status : Completed
First Posted : June 29, 2010
Last Update Posted : June 24, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

This is an open-label, multi-center study to evaluate the safety of RAD001 in Chinese patients with metastatic renal cell cancer who are intolerant of or have progressed despite treatment with vascular endothelial growth factor (VEGF)-targeted therapies. All patients will be treated with RAD001 10 mg daily until tumor progression (determined according to the Response Evaluation Criteria In Solid Tumors (RECIST) Criteria), unacceptable toxicity, death or discontinuation from the study for any other reason. At least 60 patients will be enrolled in the study. Screening and baseline evaluations will be performed within 28 days of the date when the patient signs the informed consent form. Baseline evaluations will be performed within two weeks of the first dose of RAD001. Screening and baseline evaluations will be performed to determine if patient meets all inclusion and exclusion criteria. All eligible patients should be enrolled in the study and will receive the first dose of RAD001 (10 mg daily) on Day 1, Cycle 1. Subsequently, patients will be asked to come to the clinic every month to complete the protocol-specified evaluations. A treatment Cycle consists of 28 days. After discontinuation of treatment with RAD001, patients will have a safety follow-up performed 28 days after the last dose of RAD001. Patients must continue with survival assessments which will be performed every 3 months from the last dose of RAD001 until up to 2 years after the last patient's first visit date.

An interim analysis focusing on safety data and a final analysis of all data are planned. All patients still receiving the study drug at the time of the final analysis will be given the option to continue treatment with RAD001 until the occurrence of unacceptable toxicity or disease progression.


Condition or disease Intervention/treatment Phase
Metastatic Renal Cell Carcinoma Drug: Everolimus (RAD001) Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib, Multi-center, Open-label Study to Evaluate the Safety of RAD001 in Chinese Patients With Metastatic Renal Cell Cancer Who Are Intolerant of or Who Have Progressed Despite Treatment With VEGF-targeted Therapies
Study Start Date : May 2010
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: RAD001 Drug: Everolimus (RAD001)


Outcome Measures

Primary Outcome Measures :
  1. To evaluate the safety and tolerability profile of RAD001 (10mg daily dose) in Chinese patients who are intolerant of or have progressed on or after VEGF-targeted therapy. [ Time Frame: 4 month + 12 month ]

Secondary Outcome Measures :
  1. Disease control rate (DCR), best overall response rate and progression-free survival (PFS) [ Time Frame: 12 month ]
  2. Overall survival (OS) [ Time Frame: 12 month ]
  3. Systemic pre-dose exposure levels of RAD001 in Chinese patients. [ Time Frame: 12 month ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients of Chinese origin who are ≥ 18 years old.
  • Patients with histologically or cytologically confirmed metastatic renal cell carcinoma.
  • Patients who are intolerant of or who have progression on or after stopping treatment with VEGF-targeted therapies within 6 months. Note: Prior treatment with vaccine therapy in the adjuvant setting and prior treatment with cytokines (i.e., IL-2, Interferon) or chemotherapy is permitted.
  • Patients with at least 1 measurable lesion determined according to the RECIST Criteria Guidelines.
  • Patients with history of brain metastasis who are clinically judged by the investigator as neurologically stable following definitive radiation or surgery and do not require corticosteroids may be enrolled in the study.
  • Patients with a Karnofsky Performance Status ≥ 70%.
  • Patients with adequate bone marrow function defined as ANC ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L, Hgb >9 g/dL.
  • Patients with adequate liver function defined as serum bilirubin ≤ 1.5 x ULN, ALT and AST ≤ 2.5x ULN. Patients with known liver metastases who have an AST and ALT ≤ 5x ULN.
  • Patients with adequate renal function which is defined as serum creatinine ≤ 2 x ULN.
  • Women of childbearing potential must have had a negative serum pregnancy test within 14 days prior to the administration of RAD001.
  • Patients must give written informed consent according to local guidelines

Exclusion Criteria:

  • Patients who have received chemotherapy, immunotherapy, radio-therapy or any other investigational agent (including pazopanib, axitinib) within 4 weeks of study entry, or have received sunitinib® and/or sorafenib® within 2 weeks of the first dose of RAD001.
  • Patients who have previously received RAD001 or other mTOR inhibitors.
  • Patients with a known hypersensitivity to RAD001 or other rapamycin analogs (sirolimus, temsirolimus), or to its excipients.
  • Patients who have a history of another primary malignancy ≤ 3 years, with the exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix.
  • Patients receiving chronic and systemic treatment with corticosteroids or another immunosuppressive agent. Patients may receive low dose treatment of corticosteroids with a maximum dose of 20 mg prednisone or 10 mg dexamethasone per day, if they are being given for disorders such as rheumatoid arthritis, asthma, or adrenal insufficiency. Topical or inhaled corticosteroids are permitted.
  • Patients with a clinically significant active bleeding diathesis.
  • Patients with known HIV seropositivity, hepatitis B or C seropositivity. Patients with prior hepatitis B vaccination may be entered in the study after review of hepatitis test results by the investigator.
  • Patients who have undergone major surgery within 4 weeks prior to starting study drug (e.g., intra-thoracic, intra-abdominal, or intra-pelvic), open biopsy, or significant traumatic injury, or who have not recovered from the side effects of any of the above.
  • Patients with any severe and/or uncontrolled medical conditions such as: unstable angina pectoris,symptomatic congestive heart failure,myocardial infarction ≤ 6 months,serious uncontrolled cardiac arrhythmia, uncontrolled hypercholesterolemia (>300 mg/dL or 7.75 mmol/L),uncontrolled diabetes (fasting glucose > 2x ULN),an active or uncontrolled severe infection, cirrhosis, chronic or persistent active hepatitis.
  • Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are used, they must be continued throughout the study by both sexes, and up to 8 weeks after ending treatment. Hormonal contraceptives are not acceptable as a sole method of contraception

Other protocol related inclusion/exclusion criteria

Contacts and Locations

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): NCT01152801


Locations
China, Hubei
Novartis Investigative Site
Wuhan, Hubei, China, 430030
China, Jiangsu
Novartis Investigative Site
Nanjing, Jiangsu, China, 210002
China
Novartis Investigative Site
Beijing, China, 100028
Novartis Investigative Site
Beijing, China, 100036
Novartis Investigative Site
Guangzhou, China, 510060
Novartis Investigative Site
Shanghai, China, 200127
Novartis Investigative Site
Shanghai, China, 200433
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01152801     History of Changes
Other Study ID Numbers: CRAD001L2101
Chinese HA - 2008L09346 ( Registry Identifier: Chinese HA )
First Posted: June 29, 2010    Key Record Dates
Last Update Posted: June 24, 2014
Last Verified: June 2014

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
mRCC,
everolimus,
mTOR,
intolerant of VEGF-therapies

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents