Everolimus (RAD001) and Carboplatin in Pretreated Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

Everolimus (RAD001) in Combination With Intravenous Carboplatin in Taxane- and Anthracycline-pretreated Patients With Progressive Metastatic Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00930475
• Other study ID #: CRAD001JDE15T
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: June 18, 2009
• Last updated: January 25, 2011
• Start date: February 2009

Study information

• Verified date: June 2010
• Source: Charite University, Berlin, Germany
• Contact: Jan Eucker, Dr. med.
• Email: jan.eucker[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This is an open-label, mono-center phase I/II study designed to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of RAD001 in combination with carboplatin in taxane- and anthracycline-pretreated patients with progressive metastatic breast cancer. Additionally, the study is designed to characterize the safety, the tolerability and efficacy of this study.

Description:

During the phase I part the study will include at least 3 patients at each dose-level until MTD is reached. Each cohort will consist of newly enrolled patients. Intra-patient dose escalation is not permitted. Once MTD is reached a total of 6 patients will be treated at MTD (phase I). For the phase II the minimax two-stage design will be applied. After testing the drug on 16 patients in the first stage of phase II, the trial will be terminated if 1 or fewer respond (SD, PR, CR). If the trial goes on to the second stage, a total of 34 patients will be studied during the phase II part.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult female patients

• at least two prior chemotherapies due to metastatic or inoperable breast cancer

• Karnofsky performance status of at least 60%

• pretreatment with at least one taxane and one anthracycline

Exclusion Criteria:

• previous treatment with mTOR-inhibitors, carboplatin, cisplatin or oxaliplatin

• inadequate organ function including bone marrow function

• bleeding tumours

• known uncontrolled metastases in CNS or carcinomatous meningosis

• patients who have been treated during the last five days with inhibitors or inducers of CYP3A

• serious pulmonary, neurological, endocrinological or other disorders interfering with this study medication, especially patients with known lung fibrosis, emphysema or severe COPD

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• RAD001 (Everolimus) in combination with carboplatin
phase I: dose levels: 2,5 mg, 5 mg, 7,5 mg and 10mg daily in combination with carboplatin AUC2 weekly until progress
• RAD001 (Everolimus) in combination with carboplatin
phase 2: 10mg RAD001 in combination with carboplatin

Locations

Country	Name	City	State
Germany	Charité, university medicine, Berlin, CCM	Berlin

Sponsors (3)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	KKS Netzwerk, Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I: dose limiting toxicity		after three weeks	Yes
Primary	Phase II: response rate		every six weeks	No
Secondary	Phase I: adverse events		after three weeks	Yes