Everolimus (RAD001) and Carboplatin in Pretreated Metastatic Breast Cancer

Trial Title: Everolimus (RAD001) and Carboplatin in Pretreated Metastatic Breast Cancer

NCT ID: NCT00930475

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms
Carboplatin
Everolimus

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Unknown status

Study design:

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: RAD001 (Everolimus) in combination with carboplatin
Description: 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
Intervention name: RAD001 (Everolimus) in combination with carboplatin
Description: phase 2: 10mg RAD001 in combination with carboplatin

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.

Criteria for 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

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Charité, university medicine, Berlin, CCM

Address:
City: Berlin
Zip: 10177
Country: Germany

Status: Recruiting

Investigator:
Last name: Jan Eucker, Dr. med.
Email: Principal Investigator

Start date: February 2009

Lead sponsor:
Agency: Charite University, Berlin, Germany
Agency class: Other

Collaborator:
Agency: KKS Netzwerk
Agency class: Other

Collaborator:
Agency: Novartis Pharmaceuticals
Agency class: Industry

Source: Charite University, Berlin, Germany

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT00930475