Everolimus (RAD001) and Carboplatin in Pretreated Metastatic Breast Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Charite University, Berlin, Germany.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Charite University, Berlin, Germany
Collaborators:
KKS-Charité, Koordinierungszentrum für Klinische Studien
Novartis Pharmaceuticals
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00930475
First received: June 18, 2009
Last updated: January 25, 2011
Last verified: June 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: RAD001 (Everolimus) in combination with carboplatin |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Everolimus (RAD001) in Combination With Intravenous Carboplatin in Taxane- and Anthracycline-pretreated Patients With Progressive Metastatic Breast Cancer |
Resource links provided by NLM:
Further study details as provided by Charite University, Berlin, Germany:
Primary Outcome Measures:
- Phase I: dose limiting toxicity [ Time Frame: after three weeks ] [ Designated as safety issue: Yes ]
- Phase II: response rate [ Time Frame: every six weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Phase I: adverse events [ Time Frame: after three weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 54 |
| Study Start Date: | February 2009 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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
Drug: RAD001 (Everolimus) in combination with carboplatin
phase 2: 10mg RAD001 in combination with carboplatin
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930475
Contacts
| Contact: Jan Eucker, Dr. med. | jan.eucker@charite.de |
Locations
| Germany | |
| Charité, university medicine, Berlin, CCM | Recruiting |
| Berlin, Germany, 10177 | |
| Principal Investigator: Jan Eucker, Dr. med. | |
Sponsors and Collaborators
Charite University, Berlin, Germany
KKS-Charité, Koordinierungszentrum für Klinische Studien
Novartis Pharmaceuticals
More Information
No publications provided
| Responsible Party: | Dr. Jan Eucker, Charite University medicine, Berlin, Germany |
| ClinicalTrials.gov Identifier: | NCT00930475 History of Changes |
| Other Study ID Numbers: | CRAD001JDE15T |
| Study First Received: | June 18, 2009 |
| Last Updated: | January 25, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Everolimus Sirolimus Carboplatin Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on June 17, 2013