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

This study has been completed.
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
First received: June 24, 2008
Last updated: May 5, 2014
Last verified: May 2014

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.

Condition Intervention Phase
Prostatic Neoplasms
Drug: BIBF 1120
Drug: BIBW 2992
Drug: Sequential BIBF 1120 + BIBW 2992
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Progression free rate (defined by a composite endpoint of absence of PSA, bone metastasis and RECIST progression) [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free rate at 24 and 48 weeks (based on the composite criteria) [ Time Frame: 24 and 48 weeks ] [ Designated as safety issue: No ]
  • Time to PSA progression through 48 weeks (PSAWG criteria) [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • RECIST tumour progression rate at 12, 24, 36 and 48 weeks [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • Time to progression (based on the composite criteria) [ Time Frame: 22 days onwards ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 22 days onwards ] [ Designated as safety issue: No ]
  • PSA response (PSAWG criteria) [ Time Frame: 22 days onwards ] [ Designated as safety issue: No ]
  • Duration of PSA response [ Time Frame: 22 days onwards ] [ Designated as safety issue: No ]
  • Overall objective response by RECIST criteria (CR or PR) for patients with measurable disease at 12, 24, 36 and 48 weeks [ Time Frame: up to 48 week ] [ Designated as safety issue: No ]
  • Duration of RECIST tumour response [ Time Frame: 22 days onwards ] [ Designated as safety issue: No ]
  • Incidence and intensity of Adverse Events with grading of Adverse Events according to the US NCI Common Terminology Criteria for Adverse Events (CTCAE version 3.0) [ Time Frame: 22 days onwards ] [ Designated as safety issue: No ]
  • Number of abnormalities in safety laboratory parameters [ Time Frame: 22 days onwards ] [ Designated as safety issue: No ]

Enrollment: 85
Study Start Date: March 2006
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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:
  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00706628

United Kingdom
1239.3.4402 Boehringer Ingelheim Investigational Site
Belfast, United Kingdom
1239.3.4406 Boehringer Ingelheim Investigational Site
Bournemouth, United Kingdom
1239.3.4408 Boehringer Ingelheim Investigational Site
Brighton, United Kingdom
1239.3.4409 Boehringer Ingelheim Investigational Site
Cheltenham, United Kingdom
1239.3.4405 Boehringer Ingelheim Investigational Site
Glasgow, United Kingdom
1239.3.4403 Boehringer Ingelheim Investigational Site
Newcastle Upon Tyne, United Kingdom
1239.3.4411 Boehringer Ingelheim Investigational Site
Southampton, United Kingdom
1239.3.4401 Boehringer Ingelheim Investigational Site
Sutton, United Kingdom
1239.3.4410 Boehringer Ingelheim Investigational Site
Truro, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00706628     History of Changes
Other Study ID Numbers: 1239.3
Study First Received: June 24, 2008
Last Updated: May 5, 2014
Health Authority: Great Britain: MHRA

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014