Everolimus (RAD001) and Carboplatin in Pretreated Metastatic Breast Cancer

NCT ID: NCT00930475

Last Updated: 2011-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28

Brief 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.

Detailed 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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

Intervention Type: DRUG

RAD001 (Everolimus) in combination with carboplatin

phase 2: 10mg RAD001 in combination with carboplatin

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

KKS Netzwerk

NETWORK

Sponsor Role: collaborator

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Charite University medicine, Berlin, Germany

Locations

Charité, university medicine, Berlin, CCM

Berlin, State of Berlin, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Jan Eucker, Dr. med.

Role: CONTACT

jan.eucker@charite.de

Other Identifiers

CRAD001JDE15T

Identifier Type: -

Identifier Source: org_study_id