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Study of CCNU (Lomustine) Plus Dasatinib in Recurrent Glioblastoma (GBM)
This study has been terminated.
(Inability to meet protocol objectives)
Sponsor:
Bristol-Myers Squibb
Collaborator:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00948389
First received: July 28, 2009
Last updated: August 27, 2012
Last verified: August 2012
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Purpose
To determine whether dasatinib plus lomustine are effective for treatment of recurrent glioblastoma
| Condition | Intervention | Phase |
|---|---|---|
| Glioblastoma | Drug: Dasatinib Drug: Lomustine | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Phase II of Lomustine Versus Lomustine-Dasatinib in Patients With Recurrent Glioblastoma |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs [ Time Frame: Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after cycle 6. Median number of cycles = 1.0 (range: 1.0 - 7.0). ]SAE=any untoward medical event that results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires inpatient hospitalization or prolongation. AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Treatment-related(Tx-R)=certainly, probably, possibly related and unknown relationship to study drug. AE grades(Gr) 1=Mild; 2=Moderate; 3=Severe; 4=Life-threatening.
- Number of Participants With Dose-limiting Toxicities (DLTs) [ Time Frame: The duration for observation of DLT was 2 6-week cycles in participants with escalated dose (QD to BID) and 1 6 -week cycle for participants starting with BID regime. For participants receiving dasatinib at 150 mg, DLTs were only documented over cycle 1. ]Grades (gr) according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 3.0. DLTs were defined as adverse drug reactions as follows: absolute neutrophil counts <0.5x10^9/L (gr4) lasting for 7 consecutive days; febrile neutropenia (neutrophil count <1x10^9/L and fever of >=38.5°C); thrombocytopenia (gr4); any gr3/4 nonhematological toxicity except nausea, vomiting and fever which could be rapidly controlled with appropriate measures; any toxicity which did not allow administering at least 70% of the intended dose intensity for both agents.
- Deaths Within 30 Days of Protocol Treatment Discontinuation [ Time Frame: From time of randomization through within 30 days after protocol treatment discontinuation. Median (full range) number of 6-week treatment cycles was 1.0 (1.0-7.0). ]
- Number of Participants With Worst Grade of Hematological Toxicity Per NCI CTCAE Version 3.0 Criteria [ Time Frame: Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after cycle 6. Median number of cycles = 1.0 (range: 1.0 - 7.0). ]Neutrophils (neutropenia): Grade (gr)1 <LLN-1500/mm3; Gr2 <1500-1000/mm3; Gr3 <1000-500/mm3; Gr4 <500/mm3. Leukocytes (leukopenia): Gr1 <LLN-3000/mm3; Gr2 <3000-2000/mm3; Gr3 <2000-1000/mm3; Gr4 <1000/mm3. Lymphocytes (lymphocytopenia): Gr1 <LLN-800/mm3; Gr2 <800-500/mm3; Gr3 <500-200/mm3; Gr4 <200/mm3. Platelets (thrombocytopenia): Gr1 <LLN-75,000/mm3; Gr2 <75,000-50,000/mm3; Gr3 <50,000-25,000/mm3; Gr4 <25,000/mm3. Hemoglobin (anemia): Gr1 <LLN-10.0 g/dL; Gr2 <10.0-8.0 g/dL; Gr3 <8.0-6.5 g/dL; Gr4 <6.5 g/dL. LLN/ULN=lower/upper limit of normal (normal ranges may vary by local laboratories).
- Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria [ Time Frame: Assessed at baseline, every 2 weeks during cycles 1-6 (6-week cycles), and every 6 weeks after 6 cycles. Median number of cycles = 1.0 (range: 1.0 - 7.0). ]Grades (gr) 1=mild; gr2=moderate; gr3=severe; gr4=life-threatening. For details of NCI CTCAE laboratory values for each grade, please refer to http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_30. Low Potassium=Hypokalemia, High Potassium=Hyperkalemia, Low Sodium=Hyponatremia, Low Calcium=Hypocalcemia, High Bilirubin=Hyperbilirubinemia, low phosphatase=Hypophosphatemia, Low Potassium=Hypokalemia.
Other Outcome Measures:
- Number of Participants With Disease Progression at 12 Months [ Time Frame: 12 months ]As measured by brain magnetic resonance imaging.
| Enrollment: | 28 |
| Study Start Date: | October 2009 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Dasatinib |
Drug: Dasatinib
Tablets, Oral, 100 mg, Once or Twice daily (depending on safety cohort), Until progression or toxicity
Other Name: BMS-354825
|
| Active Comparator: Lomustine |
Drug: Lomustine
Tablets, Oral, 110 mg/m², Every 6 weeks, until progression or toxicity
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with histological or cytological proven glioblastoma multiforme
- Recurrent or progressive disease documented by magnetic resonance imaging (MRI)
- World Health Organization (WHO) Performance status 0 - 2
- Patient may have been operated for recurrence
- For non operated patients, recurrent disease must be at least one bidimensionally measurable target lesion with one diameter of at least 2cm
- Patients must be on a stable or decreasing dose of corticosteroids for at least 1 week prior to baseline MRI
Exclusion Criteria:
- Patients with histological or cytological proven glioblastoma multiforme
- Completion of radiotherapy to the brain less than 3 months prior to registration/randomization
- Prior treatment with high dose radiotherapy, stereotactic radiosurgery or internal radiation therapy
- Previous or current malignancy at other sites within prior 3 years
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00948389
Please refer to this study by its ClinicalTrials.gov identifier: NCT00948389
Locations
| France | |
| Local Institution | |
| Paris Cedex, France, 75013 | |
| Italy | |
| Local Institution | |
| Bologna, Italy, 40139 | |
| Netherlands | |
| Local Institution | |
| Nijmegen, Netherlands, 6525 GA | |
| Local Institution | |
| Rotterdam, Netherlands, 3075 EA | |
| Switzerland | |
| Local Institution | |
| Lausanne, Switzerland, 1011 | |
Sponsors and Collaborators
Bristol-Myers Squibb
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00948389 History of Changes |
| Other Study ID Numbers: |
CA180-274 Protocol 26083 ( Other Identifier: EORTC ) 2009-010576-21 ( EudraCT Number ) |
| Study First Received: | July 28, 2009 |
| Results First Received: | July 25, 2012 |
| Last Updated: | August 27, 2012 |
Additional relevant MeSH terms:
|
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Dasatinib Lomustine Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Alkylating Alkylating Agents |
ClinicalTrials.gov processed this record on July 19, 2017