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Dose Finding Study of RAD001 (Everolimus, Afinitor�) in Combination With BEZ235 in Patients With Advanced Solid Tumors

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Advanced Solid Tumors; Metastatic Breast Cancer; Metastatic Renal Cell Carcinoma

Intervention: RAD001 + BEZ235 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

Study has two parts: 1. Dose-finding: to determine the maximum tolerated dose (MTD) and to evaluate the safety and tolerability of RAD001 (everolimus , Afinitor®) in combination with BEZ235 in patients with advanced solid tumors. 2. Dose-expansion: to assess safety and tolerability of RAD001 and BEZ235 at the MTD in patients with ER+/HER2- metastatic breast cancer and metastatic renal cell cancer

Clinical Details

Official title: An Open-label, Multi-center Phase I Dose-finding Study of RAD001 (Everolimus, Afinitor®) in Combination With BEZ235 in Patients With Advanced Solid Tumors

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Probability of a Dose Limiting Toxicity (DLT) by the end of the first treatment cycle (DLT)

Incidence of DLT in patients by the end of the first treatment cycle in the co-administration of RAD001 and BEZ235

Number of participants with adverse events and serious adverse events.

Secondary outcome:

Time versus blood concentration profiles

Overall Response Rate (ORR) (Complete Response (CR) + Partial Response (PR)) according to local assessments by RECIST 1.0 for renal cell carcinoma (RCC) and metastatic breast cancer (MBC) in dose expansion phase

Progresive Free Survival (PFS) according to local assessments by RECIST 1.0 for renal cell carcinoma (RCC) and metastatic breast cancer (MBC) in dose expansion phase

Duration of response (DoR) according to local assessments by RECIST 1.0 for RCC and MBC in dose expansion phase

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and female patients age 18 years or older

- In the dose finding phase, patients with histologically or cytologically confirmed

advanced solid malignancies that are metastatic or unresectable

- In the dose expansion phase, the enrollment will be limited to patients with:

Patients with metastatic renal cell carcinoma (mRCC) whose disease had progressed despite prior treatment with VEGFR-TKI (vascular endothelial growth factor receptor tyrosine kinase inhibitor) therapy (at least one but no more than two lines of VEGFR-TKI therapy) Patients with metastatic breast cancer (MBC) which is ER+/HER2-, whose disease had progressed despite prior treatment with at least one but no more than two lines of chemotherapy and at least one prior line of endocrine therapy in the metastatic setting

- WHO performance status of 0-2

- Lab parameters within specifically defined criteria

- Patients with measurable disease per RECIST 1. 0

Exclusion Criteria:

- Patients who have previously received mTOR inhibitors or PI3K inhibitors

- Patients with CNS metastases unless previously treated with surgery, whole-brain

radiation or stereotactic radiosurgery plus the disease having been stable for at least 2 months without steroid use for at least 1 month prior to the first dose of RAD001 and BEZ235. Subjects are not permitted to receive enzyme-inducing anti-epileptic drugs.

- Major surgery within 2 weeks prior to study enrollment

- Patient taking anti-cancer drug concomitantly

- Received radiation within 4 weeks prior to study enrollment (2 weeks if limited field

radiation)

- Receive chemotherapy 4 weeks prior to study enrollment

- Received live attenuated vaccines within 1 week prior to study enrollment

- History of HIV

- Any other severe and/or uncontrolled medical condition

Other protocol-defined inclusion/exclusion criteria may apply

Locations and Contacts

Novartis Investigative Site, Wilrijk 2610, Belgium

Novartis Investigative Site, Bordeaux Cedex 33075, France

Novartis Investigative Site, Montellier cedex 5 34298, France

Novartis Investigative Site, Auckland, New Zealand

Highlands Oncology Group Dept of Highlands Oncology Grp, Fayetteville, Arkansas 72703, United States

Novartis Investigative Site, Barcelona, Catalunya 08035, Spain

Washington University School of Medicine Washington University (16), St. Louis, Missouri 63110, United States

Novartis Investigative Site, High Heaton, Newcastle Upon Tyne NE7 7DN, United Kingdom

Medical University of South Carolina SC, Charleston, South Carolina 29425, United States

Novartis Investigative Site, Verona, VR 37126, Italy

Additional Information

Starting date: January 2012
Last updated: February 26, 2015

Page last updated: August 23, 2015

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