NeoplasmsPhase 1NCT00715403

A Phase I/II Open Label Extension Study of BIBF 1120 Administered Orally Once or Twice Daily to Establish Safety, Pharmacokinetics and Efficacy in Patients With Advanced Solid Tumours and Clinical Benefit From Previous Therapy With BIBF 1120

A Phase 1 study testing BIBF 1120 in people with Neoplasms, run by Boehringer Ingelheim at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective of this trial is to evaluate the long-term safety of BIBF 1120 in terms of incidence and intensity of Adverse Events and changes in safety laboratory parameters. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Neoplasms
What is being tested?: BIBF 1120
How many people: 41 participants
Where: 11 sitesin 2 countries
Study dates: Oct 2004to Sep 2009
Phase: Phase 1
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 with advanced solid tumours who have completed a previous study with BIBF 1120. The patients should not have progression of their underlying tumour disease unless there is evidence for significant clinical benefit (e.g. symptom improvement) from treatment with BIBF 1120.
Age 18 years or older
Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score <= 2
Patients must have given written informed consent (which must be consistent with ICH-GCP and local legislation)

Who cannot join

Time elapsed from last administration of BIBF 1120 in the previous trial to start of treatment in the present trial exceeds four weeks
Presence of drug related toxicity > grade 2 CTC from previous therapy with BIBF 1120 or presence of drug related continuous toxicity of grade 2 for seven or more consecutive days which would preclude ongoing chronic therapy with BIBF 1120
Active ulcers (gastro-intestinal tract, skin)
Major injuries and surgery within the past three weeks with incomplete wound healing
Hypersensitivity to BIBF 1120 or the excipients of the trial drug
Known secondary malignancy requiring therapy

Show all 22Show fewer

Active infectious disease
Significant cardiovascular diseases (i.e. uncontrolled severe hypertension, unstable angina pectoris, history of myocardial infarction, congestive heart failure > NYHA II)
Gastrointestinal disorders anticipated to interfere with the resorption of the study drug
Brain metastases requiring therapy
Absolute neutrophil count less than 1,500/mm3
Platelet count less than 100,000/mm3
Bilirubin greater than 1.5 mg/dl (> 26 µmol/L)
Aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
Serum creatinine greater than 2 mg/dl (> 176 µmol/L)
Concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug
Chemo-, radio-, or immunotherapy within the past four weeks prior to treatment with the trial drug
Patients who are sexually active and unwilling to use a medically acceptable method of contraception
Pregnancy or lactation
Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy (visit 2) or concomitantly with this trial (except for a previous study with BIBF 1120)
Patients unable to comply with the protocol
Active alcohol or drug abuse

Trial locations and contacts

11 sites in 2 countries.

Country

City, postcode or hospital

11 sites in 2 countries

France7 sites

1199.16.3306A Boehringer Ingelheim Investigational Site
Bordeaux
1199.16.3311A Boehringer Ingelheim Investigational Site
Clichy
1199.16.3311B Boehringer Ingelheim Investigational Site
Clichy
1199.16.3302A Boehringer Ingelheim Investigational Site
Paris
1199.16.3312A Boehringer Ingelheim Investigational Site
Paris
1199.16.3313A Boehringer Ingelheim Investigational Site
Paris
1199.16.3313E Boehringer Ingelheim Investigational Site
Paris

Other trials in France

Germany4 sites

1199.16.49001 Boehringer Ingelheim Investigational Site
Freiburg/Breisgau
1199.16.49004 Boehringer Ingelheim Investigational Site
Großhansdorf
1199.16.49008 Boehringer Ingelheim Investigational Site
Tübingen
1199.16.49005 Boehringer Ingelheim Investigational Site
Wiesbaden

Other trials in Germany

About this study

Official title: Extension Study to Establish Safety, Pharmacokinetics and Efficacy of BIBF 1120 in Patients With Previous Clinical Benefit From BIBF 1120

The primary objective of this trial is to evaluate the long-term safety of BIBF 1120 in terms of incidence and intensity of Adverse Events and changes in safety laboratory parameters.

Secondary objectives are the collection of further safety data (vital signs), efficacy data and the determination of pharmacokinetic characteristics during long-term therapy with BIBF 1120.

Conditions: Neoplasms
Being tested: BIBF 1120
Medical subject headings: Neoplasms

What participants receive

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

BIBF 1120Drug

What is being measured

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

Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1
All patients who had grade 1 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
Measured: From signing the informed consent until final follow-up, up to 991 days
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2
All patients who had grade 2 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
Measured: From signing the informed consent until final follow-up, up to 991 days
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3
All patients who had grade 3 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
Measured: From signing the informed consent until final follow-up, up to 991 days
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4
All patients who had grade 4 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
Measured: From signing the informed consent until final follow-up, up to 991 days
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5
All patients who had grade 5 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
Measured: From signing the informed consent until final follow-up, up to 991 days
Difference From Baseline for Liver Enzymes
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Measured: From signing the informed consent until end of treatment, up to 991 days
Difference From Baseline for Bilirubin, Creatinine and Glucose
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Measured: From signing the informed consent until end of treatment, up to 991 days
Difference From Baseline for Haemoglobin
Difference from baseline for Haemoglobin (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Measured: From baseline until end of treatment, up to 991 days
Difference From Baseline for Haematology and Differentials Parameters
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Measured: From signing the informed consent until end of treatment, up to 991 days
Difference From Baseline for Coagulation Parameters
Difference from baseline (normalized value) in coagulation parameters Prothrombin time, international normalised ratio (PT-INR) and partial thromboplastin time. Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Measured: From signing the informed consent until end of treatment, up to 991 days
Difference From Baseline for Electrolytes
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Measured: From signing the informed consent until end of treatment, up to 991 days

Secondary outcomes (7)

Clinically Relevant Abnormalities for Vital Signs
Clinically relevant abnormalities for Vital Signs (systolic blood pressure, diastolic blood pressure, and pulse rate). New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
Measured: From baseline until final follow-up, up to 991 days
Pre-dose Concentration of Nintedanib in Plasma at Steady-state (Cpre,ss)
Cpre,ss represents the pre-dose concentration of Nintedanib in Plasma at steady-state at day 29
Measured: Just before drug administration every 28±7 days after day 29
Unconfirmed Best Overall Response
Unconfirmed best overall response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0).
PD = Progressive disease.
Measured: Baseline until end of treatment, up to 991 days
Unconfirmed Best Objective Response
Unconfirmed best objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)
Measured: Baseline until end of treatment, up to 991 days
Clinical Benefit
Clinical benefit was defined as the absence of disease progression (no PD or nonevaluable clinically progressive disease) determined by RECIST (version 1.0).
Measured: Baseline until end of treatment, up to 991 days
Confirmed Objective Response
Confirmed objective response assessed by RECIST (Response Evaluation Criteria In Solid Tumours) criteria (version 1.0)
Measured: Baseline until end of treatment, up to 991 days
Progression Free Survival
Percentage of participants that experienced progression free survival (PFS), assessed by RECIST (Response Evaluation Criteria In Solid Tumours) (version 1.0), by day 1230. Progression was defined as progressive disease (PD) or non-evaluable clinically progressive disease.
PFS was defined for patients without PD at screening as the time from first treatment with the trial drug in the previous trial until onset of PD or death, whatever comes earlier.
Patients with PD could enter the trial if they showed signs of clinical benefit. For patients with PD at screening, the RECIST assessment at screening was used as a new baseline value and PFS was the time from first treatment with the trial drug in this trial until the onset of progressive disease in this trial or death, whatever comes first.
Measured: First drug administration (in previous trial) until end of treatment, up to 1230 days

Timeline

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

Oct 2004Sep 2009

First posted15 Jul 2008 (estimated)
Study startOct 2004
Primary completionSep 2009

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 1
Primary purpose: Treatment
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00715403
Sponsor's protocol ID: 1199.16
Status last verified: Nov 2014
First submitted: 11 Jul 2008
Last updated: 2 Dec 2014
Results posted: Yes, on ClinicalTrials.gov

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

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Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Extension Study to Establish Safety, Pharmacokinetics and Efficacy of BIBF 1120 in Patients With Previous Clinical Benefit From BIBF 1120
ClinicalTrials.gov ID: NCT00715403
Acronym / sponsor ID: 1199.16
Conditions: Neoplasms
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2004
Primary completion: Sep 2009 (actual)
First posted: 15 Jul 2008 (estimated)
Results: Posted 2 Dec 2014

Clinical summary

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

The primary objective of this trial is to evaluate the long-term safety of BIBF 1120 in terms of incidence and intensity of Adverse Events and changes in safety laboratory parameters.

Secondary objectives are the collection of further safety data (vital signs), efficacy data and the determination of pharmacokinetic characteristics during long-term therapy with BIBF 1120.

Study design

Primary purpose: Treatment

Who may qualify

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

Key inclusion criteria (4 listed)

Male or female patients with advanced solid tumours who have completed a previous study with BIBF 1120. The patients should not have progression of their underlying tumour disease unless there is evidence for significant clinical benefit (e.g. symptom improvement) from treatment with BIBF 1120.
Age 18 years or older
Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score <= 2
Patients must have given written informed consent (which must be consistent with ICH-GCP and local legislation)

Key exclusion criteria (22 listed)

Time elapsed from last administration of BIBF 1120 in the previous trial to start of treatment in the present trial exceeds four weeks
Presence of drug related toxicity > grade 2 CTC from previous therapy with BIBF 1120 or presence of drug related continuous toxicity of grade 2 for seven or more consecutive days which would preclude ongoing chronic therapy with BIBF 1120
Active ulcers (gastro-intestinal tract, skin)
Major injuries and surgery within the past three weeks with incomplete wound healing
Hypersensitivity to BIBF 1120 or the excipients of the trial drug

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
BIBF 1120	Drug	–

Primary outcome

Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1
Time frame: From signing the informed consent until final follow-up, up to 991 days
All patients who had grade 1 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2
Time frame: From signing the informed consent until final follow-up, up to 991 days
All patients who had grade 2 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3
Time frame: From signing the informed consent until final follow-up, up to 991 days
All patients who had grade 3 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4
Time frame: From signing the informed consent until final follow-up, up to 991 days
All patients who had grade 4 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
Incidence and Intensity of Adverse Events With Highest CTCAE Grade 5
Time frame: From signing the informed consent until final follow-up, up to 991 days
All patients who had grade 5 adverse events (AEs) as the worst grade of the AE. Incidence and intensity of Adverse Events with grading of Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE).
Difference From Baseline for Liver Enzymes
Time frame: From signing the informed consent until end of treatment, up to 991 days
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Difference From Baseline for Bilirubin, Creatinine and Glucose
Time frame: From signing the informed consent until end of treatment, up to 991 days
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Difference From Baseline for Haemoglobin
Time frame: From baseline until end of treatment, up to 991 days
Difference from baseline for Haemoglobin (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Difference From Baseline for Haematology and Differentials Parameters
Time frame: From signing the informed consent until end of treatment, up to 991 days
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Difference From Baseline for Coagulation Parameters
Time frame: From signing the informed consent until end of treatment, up to 991 days
Difference from baseline (normalized value) in coagulation parameters Prothrombin time, international normalised ratio (PT-INR) and partial thromboplastin time. Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.
Difference From Baseline for Electrolytes
Time frame: From signing the informed consent until end of treatment, up to 991 days
Difference from baseline (normalized value). Baseline was defined as the value at the time point closest to but prior to very first administration of trial medication. The standard error is actually the Interquartile Range calculated as P75 minus P25.

7 secondary outcomes

Clinically Relevant Abnormalities for Vital Signs
Time frame: From baseline until final follow-up, up to 991 days
Pre-dose Concentration of Nintedanib in Plasma at Steady-state (Cpre,ss)
Time frame: Just before drug administration every 28±7 days after day 29
Unconfirmed Best Overall Response
Time frame: Baseline until end of treatment, up to 991 days
Unconfirmed Best Objective Response
Time frame: Baseline until end of treatment, up to 991 days
Clinical Benefit
Time frame: Baseline until end of treatment, up to 991 days
Confirmed Objective Response
Time frame: Baseline until end of treatment, up to 991 days
Progression Free Survival
Time frame: First drug administration (in previous trial) until end of treatment, up to 1230 days

Results and safety

Results posted to the registry on 2 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
50mg QD	1	0
200mg QD	1	0
100mg BID	4	0
150mg BID	9	0
200mg BID	6	0
250mg BID	19	0
300mg BID	1	0

Primary outcome: Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1

Time frame: From signing the informed consent until final follow-up, up to 991 days. Number. Unit: percentage of participants

Measure	50mg QD n = 1	200mg QD n = 1	100mg BID n = 4	150mg BID n = 9	200mg BID n = 6	250mg BID n = 19	300mg BID n = 1
Dyspepsia	100	0	0	11	0	0	0
Fatigue	100	0	0	33	17	0	0
Nasopharyngitis	100	0	0	0	33	5	0
Anorexia	100	0	0	11	0	16	0
Hyperhidrosis	100	0	0	11	0	5	0
Diarrhoea	0	100	0	44	50	37	100
Bronchitis	0	100	0	0	0	0	0
Eye disorder	0	0	25	0	0	0	0

Population analysed: Treated set

Primary outcome: Incidence and Intensity of Adverse Events With Highest CTCAE Grade 2

Time frame: From signing the informed consent until final follow-up, up to 991 days. Number. Unit: percentage of participants

Measure	100mg BID n = 4	150mg BID n = 9	200mg BID n = 6	250mg BID n = 19
Fatigue	0	22	0	11
Anorexia	0	0	0	11
Diarrhoea	0	11	33	21
Bronchitis	0	0	17	0
Nausea	0	0	0	11
Vomiting	0	0	0	5
Abdominal pain	0	11	0	0
Asthenia	25	11	0	11

Population analysed: Treated set

Primary outcome: Incidence and Intensity of Adverse Events With Highest CTCAE Grade 3

Time frame: From signing the informed consent until final follow-up, up to 991 days. Number. Unit: percentage of participants

Measure	50mg QD n = 1	100mg BID n = 4	150mg BID n = 9	250mg BID n = 19
Gamma-glutamyltransferase increased	100	0	0	0
Diarrhoea	0	25	11	5
Diarrhoea infectious	0	25	0	0
Dyspnoea	0	0	11	5
Lymphopenia	0	0	0	5
Constipation	0	0	0	5
Haemorrhoids	0	0	0	5
Ileus	0	0	0	5

Population analysed: Treated set

Primary outcome: Incidence and Intensity of Adverse Events With Highest CTCAE Grade 4

Time frame: From signing the informed consent until final follow-up, up to 991 days. Number. Unit: percentage of participants

Measure	50mg QD n = 1	200mg QD n = 1	100mg BID n = 4	150mg BID n = 9	200mg BID n = 6	250mg BID n = 19	300mg BID n = 1
Value	0	0	0	0	0	0	0

Population analysed: Treated set

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first intake of trial medication until 28 days after last intake of medication, up to 1119 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
50mg QD	0 of 1 (0%)	1 of 1 (100%)	Not reported
200mg QD	0 of 1 (0%)	1 of 1 (100%)	Not reported
100mg BID	0 of 4 (0%)	4 of 4 (100%)	Not reported
150mg BID	1 of 9 (11.1%)	9 of 9 (100%)	Not reported
200mg BID	0 of 6 (0%)	6 of 6 (100%)	Not reported
250mg BID	9 of 19 (47.4%)	17 of 19 (89.5%)	Not reported
300mg BID	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 2 Dec 2014.
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

11 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BIBF 1120 in people with Neoplasms, run by Boehringer Ingelheim at 11 sites in 2 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 4 inclusion and 22 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 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France, Germany. 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 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.

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 2 Dec 2014). 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?

Incidence and Intensity of Adverse Events With Highest CTCAE Grade 1 (time frame: From signing the informed consent until final follow-up, up to 991 days). The study lists 11 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 NCT00715403.

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 2 Dec 2014.