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

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.

Timeline

Start

2006-03

Primary completion

2008-12

Completion

—

Outcome

Missed primary endpoint

registry analysis (superiority or other test); BIBF 1120 Monotherapy vs BIBW 2992 Monotherapy; p = 0.0577; Fisher Exact NCT00706628 ↗

registry analysis (superiority or other test); BIBF 1120 Monotherapy vs ComBI 40; p = 0.0863; Fisher Exact NCT00706628 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Afatinib	Small molecule	—	—
Subject	Nintedanib	Small molecule	—	—

Indications