Prostatic NeoplasmsPhase 2NCT00706628
A Multi-centre 3-arm Randomised Phase II Trial of BIBF 1120 Versus BIBW 2992 Versus Sequential Administration of BIBF 1120 and BIBW 2992 in Patients With Hormone-resistant Prostate Cancer
A Phase 2 study testing BIBF 1120, BIBW 2992 and Sequential BIBF 1120 + BIBW 2992 in people with Prostatic Neoplasms, run by Boehringer Ingelheim at 9 sites in United Kingdom.
Trial summary
The primary objective of this trial is to estimate and compare the 12-week progression-free rate of BIBF 1120, BIBW 2992 or sequential administration of BIBF 1120 and BIBW 2992 in patients with HRPC as determined by radiographic, bone and PSA criteria. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- BIBF 1120, BIBW 2992 and Sequential BIBF 1120 + BIBW 2992
- How many people
- 87 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- Mar 2006to Dec 2008
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years.
- Signed informed consent.
- Able to comply with protocol requirements.
- Histologically, cytologically or biochemically documented adenocarcinoma of the prostate, clinically refractory or resistant to hormone therapy, as documented by progression following at least one hormonal therapy, which must include orchidectomy or gonadotropin releasing hormone agonist (GnRHa).
- Progressive Disease (PD) is defined as a minimum of three consecutive serum PSA measurements obtained at least 7 days apart within the previous 3 months of start of trial, which document progressively increasing values. Patients with progression of measurable disease (RECIST) or progression of bone disease must also fit the criterion for PSA progression.
- Patients must have documented progression (as defined above) following anti-androgen withdrawal of 4 weeks duration for flutamide and 6 weeks for bicalutamide or nilutamide. For a patient who has withdrawn from anti-androgen therapy less than 6 months prior to inclusion in trial one of the following criteria is also required:
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- Following the completion of the anti-androgen withdrawal period one PSA higher than the last pre-withdrawal PSA.
- Or Following the completion of the anti-androgen withdrawal period if the PSA value has decreased, he can still qualify if 2 increases in PSA are documented after the post- withdrawal nadir.
- PSA > 5ng/mL.
- Life expectancy of at least 12 weeks.
- ECOG performance status 0-1 (see appendix 11.2).
- Stable analgesia requirements.
- Adequate hepatic function: total bilirubin < 26µmol/L, ALT and/or AST < 1.5x upper limit of normal (ULN).
- Adequate renal function: serum creatinine < 1.5 x ULN.
- INR Prothrombin time (PT) and partial thromboplastin time (PTT) <1.5 upper limit of normal.
- Absolute neutrophil count (ANC) > 1.5 x 109l, Platelets > 100 x 109/l.
- Haemoglobin > 9.0 g/dl.
- LVEF > 50 % on MUGA scan or echocardiogram.
- Castrate testosterone level [< 20ng/dl or <0.69nM (nM/L x 28.8 = ng/dl)], which must be maintained during the duration of the trial by orchidectomy or medical castration.
- Patient on oral or intravenous bisphosphonates are allowed to enter the trial as long as they have been on bisphosphonates for a minimum of 3 months.
Who cannot join
- Prior treatment with inhibitors of EGFR, HER 2 and/or VEGF receptors.
- Prior treatment with cytotoxic chemotherapy.
- Known hypersensitivity to the trial drugs or their excipients.
- Systemic corticosteroids 28 days before screening (inhaled corticosteroids prescribed for bronchospasm are allowed). Patients on long-term stable-dose steroids for concurrent illness are not excluded.
- Treatment with any investigational drug within 28 days of trial onset.
- History of other malignancies which could affect compliance with the protocol or interpretation of results within 5-years. Patients with adequately treated basal or squamous cell skin cancer are generally eligible.
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- Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality that may increase the risk associated with trial participation or trial drug administration and in the judgment of the investigator would make the patient inappropriate for entry into the trial.
- Major injuries and/or surgery within 4 weeks of trial onset or bone fracture and planned surgical procedures during the trial period.
- Significant cardiovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within past 9 months, congestive heart failure > NYHA II) (see appendix 11.5).
- History of haemorrhagic or thrombotic event in the past 12 months. Known inherited predisposition to bleeds or to thrombosis.
- Patient with history or clinical evidence of CNS disease or brain metastases.
- Patients with symptoms of impending or established spinal cord compression.
- Gastrointestinal disorders or abnormalities that would inhibit absorption of the trial drug.
- Patients who require full-dose anticoagulation.
- Radio- or immunotherapy within the past four weeks prior to treatment with the trial drug.
- Patients unable to comply with the protocol.
- Active alcohol or drug abuse.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United Kingdom9 sites
1239.3.4402 Boehringer Ingelheim Investigational Site
Belfast
1239.3.4406 Boehringer Ingelheim Investigational Site
Bournemouth
1239.3.4408 Boehringer Ingelheim Investigational Site
Brighton
1239.3.4409 Boehringer Ingelheim Investigational Site
Cheltenham
1239.3.4405 Boehringer Ingelheim Investigational Site
Glasgow
1239.3.4403 Boehringer Ingelheim Investigational Site
Newcastle upon Tyne
1239.3.4411 Boehringer Ingelheim Investigational Site
Southampton
1239.3.4401 Boehringer Ingelheim Investigational Site
Sutton
1239.3.4410 Boehringer Ingelheim Investigational Site
Truro
About this study
The primary objective of this trial is to estimate and compare the 12-week progression-free rate of BIBF 1120, BIBW 2992 or sequential administration of BIBF 1120 and BIBW 2992 in patients with HRPC as determined by radiographic, bone and PSA criteria.
- Conditions
- Prostatic Neoplasms
- Being tested
- BIBF 1120, BIBW 2992, Sequential BIBF 1120 + BIBW 2992
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBF 1120Drug
BIBW 2992Drug
Sequential BIBF 1120 + BIBW 2992Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Rate (PFR) at 12 Weeks
PFR is defined as a composite endpoint for disease progression.
If patients met one of the following criteria they were counted as having progressive disease (PD):
- Prostate serum antigen (PSA) progression according to Prostate-Specific Antigen Working Group (PSAWG) criteria
- Bone metastasis progression- development of new lesions on bone scan or development of disease-related skeletal related events (SREs)
- Disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.0
Measured: 12 weeks
Secondary outcomes (13)
Progression Free Rate at 24 and 48 Weeks
PFR is defined as a composite endpoint for disease progression.
If patients met one of the following criteria they were counted as having progressive disease (PD):
- Prostate serum antigen (PSA) progression according to Prostate-Specific Antigen Working Group (PSAWG) criteria
- Bone metastasis progression- development of new lesions on bone scan or development of disease-related skeletal related events (SREs)
- Disease progression according to RECIST version 1.0
Measured: 24 weeks and 48 weeks
Number of Patients Showing Prostate Serum Antigen (PSA) Response
PSA response was evaluated according to the PSAWG guidelines. All patients achieving a fall in PSA of ≥50% from baseline (confirmed with a second value at least 4 weeks later) fulfilled the criteria for PSA response. The confirmatory value had to be at least 50% lower than the baseline value, but could be higher than the original drop in PSA (first PSA value).
However, the confirmatory value could not be 50% higher than the first PSA value. If it was ≥50% higher than the first PSA, another sample was taken to determine if response had been achieved.
Measured: End of trial visit, 29 ± 1 days after Day 1 of the last treatment cycle (Up to 48 weeks)
Duration of PSA Response
Duration of PSA response was calculated from the time of first 50% decline in PSA (compared to baseline) until the time at which there was an increase of 50% from the PSA nadir, provided that the absolute increase was at least 5 ng/mL. The increase had to be confirmed by a second consecutive measurement that was at least 50% above the nadir. If the PSA never showed a 50% increase over the nadir value, then the patient was censored at the last PSA measurement.
Duration of PSA response expressed in median number of days.
Measured: End of trial visit, 29 ± 1 days after Day 1 of the last treatment cycle (Up to 48 weeks)
Time to PSA Progression
Time to PSA progression through 48 weeks was calculated as the number of days from first administration of study drug to the first time that there was an increase of 50% from the PSA nadir, provided the absolute increase was at least 5 ng/mL.
Time is expressed in median number of days.
Measured: Start of treatment until end of treatment (Up to 48 weeks)
RECIST Tumour Progression Rate at 12, 24, 36, and 48 Weeks
RECIST (version 1.0) tumour progression rate at 12, 24, 36, and 48 weeks was calculated based on the occurrence of new lesions, or an increase in the sum of the longest lesion diameters of at least 20%.
Measured: 12, 24, 36, and 48 weeks
Overall Objective Response by RECIST Criteria (Version 1.0) (Complete Response [CR] or Partial Response [PR]) for Patients With Measurable Disease at 12, 24, 36 and 48 Weeks
Objective response is defined as a Complete or Partial response Complete response [CR] for Target lesions: Disappearance of all target lesions. Complete response [CR] for Non- target lesions: Disappearance of all non-target lesions and normalization of tumour marker level Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Measured: 12, 24, 36 and 48 weeks
Duration of RECIST Response
Time from first observation of response (PR, CR, confirmed or unconfirmed) until progression according to RECIST (version 1.0) or death.
Duration is expressed in Median number of days.
Measured: Up to 48 weeks
Time to Progression
Time from first administration of study drug until disease progression according to composite endpoint.
Time is expressed in Median number of days.
Measured: start of treatment until end of the treatment (Up to 48 weeks)
Overall Survival (Time to Death)
Overall survival (time to death) was calculated in days from baseline to the date of reporting of death. Time is expressed in Median number of days.
Measured: start of treatment until 28 days after end of treatment (Up to 52 weeks)
Incidence and Worst Intensity of Adverse Events With Grading According CTCAE
Incidence and worst intensity of Adverse Events with grading according to the Common Terminology Criteria for Adverse Events (CTCAE version 3.0).
Measured: from first intake of treatment until 29 days after last intake of treatment (Up to 52 weeks)
Changes in Safety Laboratory Parameters
Changes in safety laboratory Parameters reported as adverse events
Measured: from first intake of treatment until 29 days after last intake of treatment (Up to 52 weeks)
Trough Plasma Concentrations for BIBF 1120 and BIBW 2992 for the Monotherapy
Trough plasma concentrations are defined either as pre-dose concentration of BIBF 1120 and BIBW 2992 in plasma at steady state immediately before administration of the next dose for the monotherapy treatment or as post dose concentrations taken after the dosing interval for the combination treatment
Measured: Day 15, Day 29 and Day 57
Trough Plasma Concentrations for BIBF 1120 and BIBW 2992 for the Combination Therapy
Trough plasma concentrations are defined either as pre-dose concentration of BIBF 1120 and BIBW 2992 in plasma at steady state immediately before administration of the next dose for the monotherapy treatment or as post dose concentrations taken after the dosing interval for the combination treatment (C12,14 for BIBF1120 ; C24,7 and C24,14 for BIBW2992)
C12,14: plasma concentration at 12 hours Day 14
Measured: Day7, Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study startMar 2006
- Primary completionDec 2008
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 Prostatic 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
- Intervention model
- Parallel groups
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706628
- Sponsor's protocol ID
- 1239.3
- Status last verified
- Jan 2015
- First submitted
- 24 Jun 2008
- Last updated
- 15 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre 3-arm Randomised Phase II Trial of BIBF 1120 Versus BIBW 2992 Versus Sequential Administration of BIBF 1120 and BIBW 2992 in Patients With Hormone-resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT00706628
- Acronym / sponsor ID
- 1239.3
- Conditions
- Prostatic Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Dec 2008 (actual)
- First posted
- 27 Jun 2008 (estimated)
- Results
- Posted 15 Jan 2015
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 estimate and compare the 12-week progression-free rate of BIBF 1120, BIBW 2992 or sequential administration of BIBF 1120 and BIBW 2992 in patients with HRPC as determined by radiographic, bone and PSA criteria.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Age >18 years.
- Signed informed consent.
- Able to comply with protocol requirements.
- Histologically, cytologically or biochemically documented adenocarcinoma of the prostate, clinically refractory or resistant to hormone therapy, as documented by progression following at least one hormonal therapy, which must include orchidectomy or gonadotropin releasing hormone agonist (GnRHa).
- Progressive Disease (PD) is defined as a minimum of three consecutive serum PSA measurements obtained at least 7 days apart within the previous 3 months of start of trial, which document progressively increasing values. Patients with progression of measurable disease (RECIST) or progression of bone disease must also fit the criterion for PSA progression.
Key exclusion criteria (17 listed)
- Prior treatment with inhibitors of EGFR, HER 2 and/or VEGF receptors.
- Prior treatment with cytotoxic chemotherapy.
- Known hypersensitivity to the trial drugs or their excipients.
- Systemic corticosteroids 28 days before screening (inhaled corticosteroids prescribed for bronchospasm are allowed). Patients on long-term stable-dose steroids for concurrent illness are not excluded.
- Treatment with any investigational drug within 28 days of trial onset.
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 | – |
| BIBW 2992 | Drug | – |
| Sequential BIBF 1120 + BIBW 2992 | Drug | – |
Primary outcome
Progression Free Rate (PFR) at 12 Weeks
Time frame: 12 weeks
PFR is defined as a composite endpoint for disease progression. If patients met one of the following criteria they were counted as having progressive disease (PD): * Prostate serum antigen (PSA) progression according to Prostate-Specific Antigen Working Group (PSAWG) criteria * Bone metastasis progression- development of new lesions on bone scan or development of disease-related skeletal related events (SREs) * Disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.0
13 secondary outcomes
Progression Free Rate at 24 and 48 Weeks
Time frame: 24 weeks and 48 weeks
Number of Patients Showing Prostate Serum Antigen (PSA) Response
Time frame: End of trial visit, 29 ± 1 days after Day 1 of the last treatment cycle (Up to 48 weeks)
Duration of PSA Response
Time frame: End of trial visit, 29 ± 1 days after Day 1 of the last treatment cycle (Up to 48 weeks)
Time to PSA Progression
Time frame: Start of treatment until end of treatment (Up to 48 weeks)
RECIST Tumour Progression Rate at 12, 24, 36, and 48 Weeks
Time frame: 12, 24, 36, and 48 weeks
Overall Objective Response by RECIST Criteria (Version 1.0) (Complete Response [CR] or Partial Response [PR]) for Patients With Measurable Disease at 12, 24, 36 and 48 Weeks
Time frame: 12, 24, 36 and 48 weeks
Duration of RECIST Response
Time frame: Up to 48 weeks
Time to Progression
Time frame: start of treatment until end of the treatment (Up to 48 weeks)
Overall Survival (Time to Death)
Time frame: start of treatment until 28 days after end of treatment (Up to 52 weeks)
Incidence and Worst Intensity of Adverse Events With Grading According CTCAE
Time frame: from first intake of treatment until 29 days after last intake of treatment (Up to 52 weeks)
Changes in Safety Laboratory Parameters
Time frame: from first intake of treatment until 29 days after last intake of treatment (Up to 52 weeks)
Trough Plasma Concentrations for BIBF 1120 and BIBW 2992 for the Monotherapy
Time frame: Day 15, Day 29 and Day 57
Trough Plasma Concentrations for BIBF 1120 and BIBW 2992 for the Combination Therapy
Time frame: Day7, Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2015.
- 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
9 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 BIBF 1120, BIBW 2992 and Sequential BIBF 1120 + BIBW 2992 in people with Prostatic Neoplasms, run by Boehringer Ingelheim at 9 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 20 inclusion and 17 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 15 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 15 Jan 2015). 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?
Progression Free Rate (PFR) at 12 Weeks (time frame: 12 weeks). 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 15 Jan 2015.