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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 December 2015
• Main ID: NCT01482156
• Date of registration: 26/09/2011
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Dose Finding Study of RAD001 (Everolimus, Afinitor®) in Combination With BEZ235 in Patients With Advanced Solid Tumors
• Scientific 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
• Date of first enrolment: January 2012
• Target sample size: 46
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01482156
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Belgium, France, Italy, Korea, Republic of, New Zealand, Spain, United Kingdom, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Metastatic Breast Cancer

Advanced Solid Tumors

Metastatic Renal Cell Carcinoma

Intervention(s)

Drug: RAD001 + BEZ235

Primary Outcome(s)

?Incidence of DLT in patients by the end of the first treatment cycle in the co-administration of RAD001 and BEZ235 [Time Frame: First treatment cycle (28 days)]

Probability of a Dose Limiting Toxicity (DLT) by the end of the first treatment cycle (DLT) [Time Frame: First treatment cycle (28 days)]

Number of participants with adverse events and serious adverse events. [Time Frame: 12 months]

Secondary Outcome(s)

Duration of response (DoR) according to local assessments by RECIST 1.0 for RCC and MBC in dose expansion phase [Time Frame: 8 weeks]

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 [Time Frame: 8 weeks]

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 [Time Frame: 8 weeks]

Time versus blood concentration profiles [Time Frame: First treatment cycle ( 28 days)]

Secondary ID(s)

CRAD001X2109

2011-001425-24

Source(s) of Monetary Support

Please refer to primary and secondary sponsors