GlioblastomaPhase 1/2NCT00948389

Study of CCNU (Lomustine) Plus Dasatinib in Recurrent Glioblastoma (GBM)

A Phase 1/2 study testing Dasatinib and Lomustine in people with Glioblastoma, run by Bristol-Myers Squibb at 5 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

To determine whether dasatinib plus lomustine are effective for treatment of recurrent glioblastoma Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glioblastoma
What is being tested?: Dasatinib and Lomustine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 5 sitesin 4 countries
Study dates: Oct 2009to May 2011
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

5 sites in 4 countries.

Country

City, postcode or hospital

5 sites in 4 countries

Netherlands2 sites

Local Institution
Nijmegen, 6525 GA
Local Institution
Rotterdam, 3075 EA

Other trials in Netherlands

France1 site

Local Institution
Paris, 75013

Other trials in France

Italy1 site

Local Institution
Bologna, 40139

Other trials in Italy

Switzerland1 site

Local Institution
Lausanne, 1011

Other trials in Switzerland

About this study

Official title: Randomized Phase II of Lomustine Versus Lomustine-Dasatinib in Patients With Recurrent Glioblastoma

To determine whether dasatinib plus lomustine are effective for treatment of recurrent glioblastoma

Conditions: Glioblastoma
Being tested: Dasatinib, Lomustine
Medical subject headings: Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DasatinibDrug
Also called BMS-354825
Tablets, Oral, 100 mg, Once or Twice daily (depending on safety cohort), Until progression or toxicity
LomustineDrug
Tablets, Oral, 110 mg/m², Every 6 weeks, until progression or toxicity

Study groups in NCT00948389
Study group	Role	What they receive
Dasatinib	Active comparator	Not described Receives: Drug: Dasatinib
Lomustine	Active comparator	Not described Receives: Drug: Lomustine

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs
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.
Measured: 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).
Number of Participants With Dose-limiting Toxicities (DLTs)
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.
Measured: 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.
Deaths Within 30 Days of Protocol Treatment Discontinuation
Measured: 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
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).
Measured: 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).
Number of Participants With Worst Grade of Biochemistry Abnormality Per NCI CTCAE Version 3.0 Criteria
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.
Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009May 2011

First posted29 Jul 2009 (estimated)
Study startOct 2009
Primary completionMay 2011
Study completionMay 2011

Why it stopped: Inability to meet protocol objectives

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GlioblastomaStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00948389
Sponsor's protocol ID: CA180-274
Other IDs: Protocol 26083, 2009-010576-21, 2009
Status last verified: Aug 2012
First submitted: 28 Jul 2009
Last updated: 31 Aug 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma

All Glioblastoma trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Phase II of Lomustine Versus Lomustine-Dasatinib in Patients With Recurrent Glioblastoma
ClinicalTrials.gov ID: NCT00948389
Acronym / sponsor ID: CA180-274
Conditions: Glioblastoma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Inability to meet protocol objectives
Enrolment: 28 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Collaborators: European Organisation for Research and Treatment of Cancer - EORTC
Study start: Oct 2009
Primary completion: May 2011 (actual)
Study completion: May 2011 (actual)
First posted: 29 Jul 2009 (estimated)
Results: Posted 28 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To determine whether dasatinib plus lomustine are effective for treatment of recurrent glioblastoma

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Dasatinib	Active comparator	Drug: Dasatinib
Lomustine	Active comparator	Drug: Lomustine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DasatinibAlso: BMS-354825Tablets, Oral, 100 mg, Once or Twice daily (depending on safety cohort), Until progression or toxicity	Drug	Dasatinib
LomustineTablets, Oral, 110 mg/m², Every 6 weeks, until progression or toxicity	Drug	Lomustine

Primary outcome

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.

Results and safety

Results posted to the registry on 28 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2	6	0
Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2	3	0
Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2	7	0
Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2	9	0
Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2	1	0

Primary outcome: 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).. Number. Unit: participants

Measure	Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 n = 6	Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 n = 3	Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 n = 7	Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 n = 9	Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 n = 1
Deaths within 30 days of Tx Discontinuation	1	0	1	0	0
Tx-R Deaths within 30 days of Tx Discontinuation	0	0	0	0	0
At Least 1 SAE	5	1	4	4	0
At Least 1 Tx-R SAE	4	0	1	1	0
Discontinuations Due to AEs	3	0	0	1	0
At Least 1 AE	6	3	7	9	1
At Least 1 Gr 3/4 AE	2	2	4	4	0
At Least 1 Tx-R AE	5	2	5	7	1

Population analysed: All treated participants

Primary outcome: 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.. Number. Unit: participants

Measure	Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 n = 5	Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 n = 0	Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 n = 5	Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 n = 9	Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 n = 0
Value	3	–	3	4	–

Population analysed: Evaluable Participants: subset of participants used to decide on dose escalations. Participants were assessable if they completed the period for DLT observation.

Primary outcome: 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. Unit: participants

Measure	Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 n = 6	Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 n = 3	Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 n = 7	Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 n = 9	Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 n = 1
Value	1	0	1	0	0

Population analysed: Treated participants

Primary outcome: 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).. Number. Unit: participants

Measure	Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2 n = 6	Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2 n = 3	Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2 n = 7	Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2 n = 9	Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2 n = 1
At least 1 Grade 1-4 Neutropenia	3	2	2	5	0
At least 1 Grade 1-4 Leukopenia	5	3	4	6	0
At least 1 Grade 1-4 Lymphocytopenia	5	2	4	9	0
At least 1 Grade 1-4 Thrombocytopenia	6	3	6	9	1
At least 1 Grade 1-4 Anemia	6	1	6	9	0
At least 1 Grade 3-4 Neutropenia	2	1	0	4	0
At least 1 Grade 3-4 Leukopenia	1	1	0	4	0
At least 1 Grade 3-4 Lymphocytopenia	4	0	1	5	0

Population analysed: Treated participants

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2	5 of 6 (83.3%)	6 of 6 (100%)	Not reported
Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2	4 of 7 (57.1%)	7 of 7 (100%)	Not reported
Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2	3 of 9 (33.3%)	9 of 9 (100%)	Not reported
Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2	0 of 1 (0%)	1 of 1 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Glioblastoma

Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

5 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Dasatinib and Lomustine in people with Glioblastoma, run by Bristol-Myers Squibb at 5 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Netherlands, France, Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00948389.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2012.