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

NCT00706628 | Completed Phase 2 Results

• 1 other identifier: 1239.3
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (13)

• Progression Free Rate at 24 and 48 Weeks

  24 weeks and 48 weeks

• Number of Patients Showing Prostate Serum Antigen (PSA) Response

  End of trial visit, 29 ± 1 days after Day 1 of the last treatment cycle (Up to 48 weeks)

• Duration of PSA Response

  End of trial visit, 29 ± 1 days after Day 1 of the last treatment cycle (Up to 48 weeks)

• Time to PSA Progression

  Start of treatment until end of treatment (Up to 48 weeks)

• RECIST Tumour Progression Rate at 12, 24, 36, and 48 Weeks

  12, 24, 36, and 48 weeks

Interventions

BIBF 1120 DRUG

BIBW 2992 DRUG

Sequential BIBF 1120 + BIBW 2992 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (9)

1239.3.4402 Boehringer Ingelheim Investigational Site

Belfast, United Kingdom

Location

1239.3.4406 Boehringer Ingelheim Investigational Site

Bournemouth, United Kingdom

Location

1239.3.4408 Boehringer Ingelheim Investigational Site

Brighton, United Kingdom

Location

1239.3.4409 Boehringer Ingelheim Investigational Site

Cheltenham, United Kingdom

Location

1239.3.4405 Boehringer Ingelheim Investigational Site

Glasgow, United Kingdom

Location

1239.3.4403 Boehringer Ingelheim Investigational Site

Newcastle upon Tyne, United Kingdom

Location

1239.3.4411 Boehringer Ingelheim Investigational Site

Southampton, United Kingdom

Location

1239.3.4401 Boehringer Ingelheim Investigational Site

Sutton, United Kingdom

Location

1239.3.4410 Boehringer Ingelheim Investigational Site

Truro, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

nintedanib; Afatinib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Data from the ComBI 70 group were not included in analyses of efficacy, data was available for one patient for this group for the primary outcome however is not reported to avoid reporting patient level data.

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 24, 2008
• First Posted: June 27, 2008
• Study Start: March 1, 2006
• Primary Completion: December 1, 2008
• Last Updated: January 15, 2015
• Results First Posted: January 15, 2015

Record last verified: 2015-01

Locations

GB (9)