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

Sponsor:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 18, 2009

Last Updated Date

January 25, 2011

Start Date ^ICMJE

February 2009

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00930475 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Phase I: adverse events [ Time Frame: after three weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Everolimus (RAD001) and Carboplatin in Pretreated Metastatic Breast Cancer

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jan Eucker, Dr. med.

jan.eucker@charite.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00930475

Other Study ID Numbers ^ICMJE

CRAD001JDE15T

Has Data Monitoring Committee

Yes

Responsible Party

Dr. Jan Eucker, Charite University medicine, Berlin, Germany

Study Sponsor ^ICMJE

Charite University, Berlin, Germany

Collaborators ^ICMJE

KKS-Charité, Koordinierungszentrum für Klinische Studien
Novartis Pharmaceuticals

Investigators ^ICMJE

Not Provided

Information Provided By

Charite University, Berlin, Germany

Verification Date

June 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top