NeoplasmsPhase 2NCT00875433
Afatinib (BIBW 2992) QTcF Trial in Patients With Relapsed or Refractory Solid Tumours
A Phase 2 study testing BIBW 2992 in people with Neoplasms, run by Boehringer Ingelheim at 4 sites in United Kingdom.
Trial summary
A phase II trial to assess the impact of afatinib (BIBW 2992) on the heart (QTcF) and the effectiveness of afatinib (BIBW 2992) in treating certain cancers. Cancers studied will include glioblastoma and cancers which have spread to the brain (metastases). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- BIBW 2992
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Mar 2009to Apr 2011
- Phase
- Phase 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
- Male or female patients aged at least 18 years old.
- Histologically or cytologically confirmed diagnosis of a solid malignant tumour, known to express EGFR/HER2 that is either refractory to standard therapies, or for which no standard treatment is available (including patients with brain metastases).
- At least one tumor lesion that can accurately be measured by computed tomography (CT) or magnetic resonance imaging (MRI) in at least one dimension with longest diameter to be recorded as greater than or equal to 20 mm using conventional techniques or greater than or equal to 10 mm with spiral CT scan.
- Life expectancy of at least 3 months.
- Written informed consent that is consistent with ICH-GCP guidelines.
- Eastern Cooperative Oncology Group (ECOG) performance score 0,1 or 2.
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- Patients must have recovered from any previous surgery.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) for the duration of trial participation. Female patients with reproductive potential must have a negative serum pregnancy test within 7 days of trial enrolment. Breast feeding mothers will be excluded since these agents may be toxic to infants.
- For patients with Glioma and brain metastases the following additional inclusion criteria should apply:
- Histologically-confirmed WHO Grade IV malignant glioma at first episode of recurrence after prior combined chemo-radiotherapy. Patients with prior low-grade glioma are eligible if histological assessment demonstrates transformation to WHO Grade IV malignant glioma.
- Bi-dimensionally measurable disease with a minimum measurement of 1 cm (10 mm) in one diameter on Gd MRI performed within 14 days prior to first treatment (Day 1).
Who cannot join
- Major exclusion criteria; 9. Radiotherapy within the past 2 weeks prior to treatment with the trial drug. 10. Chemo-, hormone- (other than megestrol acetate or steroids required for maintenance non-cancer therapy) or immunotherapy within the past 4 weeks before first drug administration.
- 11. Patients not completely recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies to CTC < Grade 1. Prior chemotherapy is allowed if completed at least 4 weeks prior to first trial treatment (6 weeks for mitomycin C or nitrosoureas) and the patient has recovered from the acute toxicities of that therapy.
- 12. Prior treatment with EGFR targeting therapies or treatment with EGFR- or HER2 inhibiting drugs within the past four weeks before start of therapy or concomitantly with this trial.
- 15. History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of 3.
- 16. Cardiac left ventricular function with resting ejection fraction < 50% measured by multigated blood pool imaging of the heart (MUGA scan) or Echocardiogram.
- 17. QTcF- interval > 470 ms at screening. 18. PR-interval > 230 ms at screening. 19. QRS-interval >120 ms at screening. 20. ST-segment and T/U-wave abnormalities at screening, as will be assessed by a cardiology specialist of a central lab.
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- 21. Absolute neutrophil count (ANC) < 1,500/mm3. 22. Platelet count < 100,000 / mm3. 23. Bilirubin > 1.5 mg / dl (>26 micro mol / L, SI unit equivalent). Aspartate amino transferase (AST) or alanine amino transferase (ALT) > or equal to three times the upper limit of normal (if related to liver metastases > five times the upper limit of normal).
- 24. Serum creatinine > 1.5 times of the upper normal limit or calculated/measured creatinine clearance > or equal to 45 ml / min.
- 25. Patients with known Interstitial Lung Disease (ILD) For Patients with glioma and brain metastases additional exclusion criteria apply;
- Patients with untreated or symptomatic brain metastases. Patients with treated, asymptomatic brain metastases are eligible if there has been no change in brain disease status for at least four (4) weeks, no history of cerebral oedema or bleeding in the past four (4) weeks. Steroids will be allowed. Anti-epileptic therapy will be allowed if no changes are anticipated within the initial 14 days of treatment (QTC-evaluation).
- Less than 4 weeks between radiotherapy and start of study treatment, unless new enhancing lesion outside of radiation field or radiologically progressive on two consecutive MRI scans at least four weeks apart or biopsy-proven recurrence.
- Less than two weeks from surgical resection (one week from prior stereotactic biopsy) or major surgical procedure.
- Less than two weeks after previous chemotherapy (6 weeks from nitrosureas).
- Less than four weeks from prior treatment with bevacizumab.
- Treatment with other investigational drugs; participation in another clinical study within the past 2 weeks before start of therapy or concomitantly with this study.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
1200.24.4403 Boehringer Ingelheim Investigational Site
Guildford
1200.24.4402 Boehringer Ingelheim Investigational Site
London
1200.24.4404 Boehringer Ingelheim Investigational Site
London
1200.24.4401 Boehringer Ingelheim Investigational Site
Sutton
About this study
Official title: Phase II Open Label Trial to Assess the Efficacy and the Impact on QTcF of Continuous Oral BIBW 2992 at a Daily Dose of 50mg in Patients With Relapsed or Refractory Solid Tumours Including Patients With Brain Metastases and Those With Glioblastoma Not Amenable to Other Therapy
A phase II trial to assess the impact of afatinib (BIBW 2992) on the heart (QTcF) and the effectiveness of afatinib (BIBW 2992) in treating certain cancers. Cancers studied will include glioblastoma and cancers which have spread to the brain (metastases).
- Conditions
- Neoplasms
- Being tested
- BIBW 2992
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBW 2992Drug
patients to receive continuous oral daily dosing of BIBW 2992
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy | Experimental | BIBW 2992 high dose, once daily, continuous, monotherapy Receives: Drug: BIBW 2992 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response (OR)
OR is defined as complete response and partial response (PR) and was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST) for solid tumours (excluding glioblastomas).
Measured: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Average Time-matched QT Corrected by the Fridericia Formula (QTcF) Change From Baseline to Day 14
Average time-matched QT corrected by the Fridericia formula (QTcF) change from baseline to day 14 over 1 to 24 hours following administration of afatinib.
Measured: The day before the first drug dose (baseline) and the day 14. Electrocardiograms (ECG) were performed at time point 0 and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h, 24 h thereafter.
Secondary outcomes (20)
Progression-free Survival (PFS)
PFS was defined as the time from the first treatment to the occurrence of tumour progression or death, whichever came first. It was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to RECIST for solid tumours (excluding glioblastomas) as well as by the investigators assessment. Median time results from unstratified Kaplan-Meier estimates.
Measured: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Overall Survival (OS)
Overall survival (OS) is defined as time from start of treatment to death.
Measured: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Disease Control
Disease control was defined as CR, PR or stable disease (SD) and was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to RECIST for solid tumours (excluding glioblastomas).
Measured: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Duration of Disease Control (DC)
Duration of Disease control (DC). DC was defined as CR, PR or stable disease (SD) and was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to RECIST for solid tumours (excluding glioblastomas).
Measured: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Patients With Notable Findings in QTcF on Day 14
Notable findings are defined as a QTcF>500 ms or an increase in QTcF of >60ms.
Measured: Day 14
Patients With Clinically Relevant Findings in ECG on Day 14
Patients with clinically relevant findings in Electrocardiogram data (ECG) on day 14.
Measured: Day 14
Time-matched QTcF Changes From Baseline to Day 14 at Each Time-point
Individual QTcF measurements at each time-point. Response was defined as the change from baseline. Analysis adjusted for baseline using a mixed model.
Measured: Baseline and day 14 (at 1, 2, 3, 4, 5, 6, 7, 10, 24 hours post-dose )
Average Time-matched QT Change From Baseline to Day 14
Average time-matched QT change from baseline to day 14 over 1 to 24 hours following administration of afatinib.
Measured: The day before the first drug dose (baseline) and the day 14. Electrocardiograms (ECG) were performed at time point 0 and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h, 24 h thereafter.
Patients With Notable Findings in QT on Day 14
Number of Patients with notable findings in QT on day 14. Notable findings are defined as a QT>500 ms.
Measured: Day 14
Average Time-matched Heart Rate Change From Baseline to Day 14.
Average time-matched heart rate change from baseline to day 14.
Measured: The day before the first drug dose (baseline) and the day 14.
Highest CTC Grade for Adverse Events
Highest Common Terminology Criteria (CTC) grade for adverse events
Measured: First administration of trial medication until 28 days after last administration of trial medication
Area Under Curve 0-24 Hours (AUC0-24) on Day 1
AUC0-24 represents the area under the concentration curve of afatinib in plasma from 0 to 24 hours on Day 1.
Measured: 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1
Maximum Concentration (Cmax)
Cmax represents the maximum measured concentration of afatinib in plasma on Day 1.
Measured: 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1
Time From Dosing to the Maximum Concentration (Tmax)
tmax represents the time from dosing to the maximum concentration of afatinib in plasma on Day 1.
Measured: 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1
Area Under Curve of Afatinib Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss)
AUCtau,ss represents the area under the concentration curve of afatinib in plasma over a uniform dosing interval tau (24h) at steady state (Day14).
Measured: 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14
Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss)
Cmax,ss represents the maximum measured concentration of afatinib in plasma at steady state (Day 14).
Measured: 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14
Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss)
tmax,ss represents the time from dosing to the maximum concentration of afatinib in plasma at steady state (Day 14).
Measured: 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14
Accumulation Ratio of AUC Values (R_A,AUC)
R_A,AUC represents the accumulation ratio of AUC values after multiple dose administration over a uniform dosing interval t between days 1 and 14
Measured: 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1 and 14
Accumulation Ratio of AUC Values (R_A,Cmax)
R_A,Cmax represents the accumulation ratio of Cmax values after multiple dose administration over a uniform dosing interval t between days 1 and 14
Measured: 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1 and 14
Percentage Peak Trough Fluctuation (PTF)
PTF represents the percentage peak trough fluctuation. PTF is defined as difference between maximum and minimum concentration at steady state divided by the average concentration multiplied with 100 to report as percentage.
Measured: 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2011
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 NeoplasmsStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875433
- Sponsor's protocol ID
- 1200.24
- Other IDs
- 2008-006288-36, 2008
- Status last verified
- Oct 2013
- First submitted
- 2 Apr 2009
- Last updated
- 30 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Open Label Trial to Assess the Efficacy and the Impact on QTcF of Continuous Oral BIBW 2992 at a Daily Dose of 50mg in Patients With Relapsed or Refractory Solid Tumours Including Patients With Brain Metastases and Those With Glioblastoma Not Amenable to Other Therapy
- ClinicalTrials.gov ID
- NCT00875433
- Acronym / sponsor ID
- 1200.24
- Conditions
- Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Apr 2011 (actual)
- First posted
- 3 Apr 2009 (estimated)
- Results
- Posted 13 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase II trial to assess the impact of afatinib (BIBW 2992) on the heart (QTcF) and the effectiveness of afatinib (BIBW 2992) in treating certain cancers. Cancers studied will include glioblastoma and cancers which have spread to the brain (metastases).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monotherapy | Experimental | Drug: BIBW 2992BIBW 2992 high dose, once daily, continuous, monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female patients aged at least 18 years old.
- Histologically or cytologically confirmed diagnosis of a solid malignant tumour, known to express EGFR/HER2 that is either refractory to standard therapies, or for which no standard treatment is available (including patients with brain metastases).
- At least one tumor lesion that can accurately be measured by computed tomography (CT) or magnetic resonance imaging (MRI) in at least one dimension with longest diameter to be recorded as greater than or equal to 20 mm using conventional techniques or greater than or equal to 10 mm with spiral CT scan.
- Life expectancy of at least 3 months.
- Written informed consent that is consistent with ICH-GCP guidelines.
Key exclusion criteria (15 listed)
- Major exclusion criteria; 9. Radiotherapy within the past 2 weeks prior to treatment with the trial drug. 10. Chemo-, hormone- (other than megestrol acetate or steroids required for maintenance non-cancer therapy) or immunotherapy within the past 4 weeks before first drug administration.
- 11. Patients not completely recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies to CTC < Grade 1. Prior chemotherapy is allowed if completed at least 4 weeks prior to first trial treatment (6 weeks for mitomycin C or nitrosoureas) and the patient has recovered from the acute toxicities of that therapy.
- 12. Prior treatment with EGFR targeting therapies or treatment with EGFR- or HER2 inhibiting drugs within the past four weeks before start of therapy or concomitantly with this trial.
- 15. History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of 3.
- 16. Cardiac left ventricular function with resting ejection fraction < 50% measured by multigated blood pool imaging of the heart (MUGA scan) or Echocardiogram.
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 |
|---|---|---|
| BIBW 2992patients to receive continuous oral daily dosing of BIBW 2992 | Drug | Monotherapy |
Primary outcome
Objective Response (OR)
Time frame: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
OR is defined as complete response and partial response (PR) and was assessed according to the Macdonald criteria for glioblastomas and brain metastases and according to Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST) for solid tumours (excluding glioblastomas).
Average Time-matched QT Corrected by the Fridericia Formula (QTcF) Change From Baseline to Day 14
Time frame: The day before the first drug dose (baseline) and the day 14. Electrocardiograms (ECG) were performed at time point 0 and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h, 24 h thereafter.
Average time-matched QT corrected by the Fridericia formula (QTcF) change from baseline to day 14 over 1 to 24 hours following administration of afatinib.
20 secondary outcomes
Progression-free Survival (PFS)
Time frame: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Overall Survival (OS)
Time frame: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Disease Control
Time frame: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Duration of Disease Control (DC)
Time frame: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
Patients With Notable Findings in QTcF on Day 14
Time frame: Day 14
Patients With Clinically Relevant Findings in ECG on Day 14
Time frame: Day 14
Time-matched QTcF Changes From Baseline to Day 14 at Each Time-point
Time frame: Baseline and day 14 (at 1, 2, 3, 4, 5, 6, 7, 10, 24 hours post-dose )
Average Time-matched QT Change From Baseline to Day 14
Time frame: The day before the first drug dose (baseline) and the day 14. Electrocardiograms (ECG) were performed at time point 0 and 1 hour (h), 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h, 24 h thereafter.
Patients With Notable Findings in QT on Day 14
Time frame: Day 14
Average Time-matched Heart Rate Change From Baseline to Day 14.
Time frame: The day before the first drug dose (baseline) and the day 14.
Highest CTC Grade for Adverse Events
Time frame: First administration of trial medication until 28 days after last administration of trial medication
Area Under Curve 0-24 Hours (AUC0-24) on Day 1
Time frame: 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1
Maximum Concentration (Cmax)
Time frame: 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1
Time From Dosing to the Maximum Concentration (Tmax)
Time frame: 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1
Area Under Curve of Afatinib Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss)
Time frame: 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14
Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss)
Time frame: 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14
Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss)
Time frame: 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14
Accumulation Ratio of AUC Values (R_A,AUC)
Time frame: 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1 and 14
Accumulation Ratio of AUC Values (R_A,Cmax)
Time frame: 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 1 and 14
Percentage Peak Trough Fluctuation (PTF)
Time frame: 0.05 hours (h) before dosing and 1h, 2h, 3h, 4h, 5h, 6h,7h, 10h and 24h after dosing on Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIBW 2992 in people with Neoplasms, run by Boehringer Ingelheim at 4 sites in United Kingdom.
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 11 inclusion and 15 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: finished, as of the sponsor's last update on 30 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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 phase mean?
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 13 Nov 2013). 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?
Objective Response (OR) (time frame: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2013.