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 Netzwerk
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
  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:
    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
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Netzwerk
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
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on August 26, 2014