Phase 2
Completed N=87
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
Source: ClinicalTrials.gov NCT00706628 ↗Enrolled (actual)
87
Serious AEs
21.2%
Results posted
Jan 2015
Primary outcomePrimary: Progression Free Rate (PFR) at 12 Weeks — 25.9; 0.0; 0.0; NA percentage of participants — p=0.0577
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Rate (PFR) at 12 Weeks |
25.9; 0.0; 0.0; NA | 0.0577 |
| SECONDARY Progression Free Rate at 24 and 48 Weeks |
22.2; 0.0; 0.0; 18.5; 0.0; 0.0 | — |
| SECONDARY Number of Patients Showing Prostate Serum Antigen (PSA) Response |
3.7; 0.0; 10.0; 96.3; 100.0; 90.0 | — |
| SECONDARY Duration of PSA Response |
NA; NA; NA | — |
| SECONDARY Time to PSA Progression |
31.0; 29.0; 57.0 | — |
| SECONDARY RECIST Tumour Progression Rate at 12, 24, 36, and 48 Weeks |
8.3; 50.0; 42.9; 50.0; 0.0; 0.0 | — |
| SECONDARY 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 |
8.3; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Duration of RECIST Response |
116.0; NA; NA | — |
| SECONDARY Time to Progression |
31.0; 29.0; 57.0 | — |
| SECONDARY Overall Survival (Time to Death) |
NA; NA; NA | — |
| SECONDARY Incidence and Worst Intensity of Adverse Events With Grading According CTCAE |
26.1; 0.0; 37.5; 0.0; 30.4; 55.0 | — |
| SECONDARY Changes in Safety Laboratory Parameters |
17.4; 5.0; 18.8; 33.3; 4.3; 0.0 | — |
| SECONDARY Trough Plasma Concentrations for BIBF 1120 and BIBW 2992 for the Monotherapy |
10.2; 18.0; 11.8; 19.1; 11.8; 18.2 | — |
| SECONDARY Trough Plasma Concentrations for BIBF 1120 and BIBW 2992 for the Combination Therapy |
13.7; 11.4; 16.4 | — |
Eligibility Criteria
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 1.5 x 109l, Platelets > 100 x 109/l.
- Haemoglobin > 9.0 g/dl.
- LVEF > 50 % on MUGA scan or echocardiogram.
- Castrate testosterone level [ 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.
Data sourced from ClinicalTrials.gov (NCT00706628). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.