Trial · NCT01200810

Bicalutamide and RO4929097 in Treating Patients With Previously Treated Prostate Cancer

NCT01200810, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2014-10-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Bicalutamide and RO4929097 in Treating Patients With Previously Treated Prostate Cancer. Trials, record NCT01200810. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01200810

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Bicalutamide and RO4929097 in Treating Patients With Previously Treated Prostate Cancer
NCT number: NCT01200810
Status: Terminated
Phases: Phase 2
Enrollment: 10 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IV Prostate Cancer
Interventions: placebo, gamma-secretase/Notch signalling pathway inhibitor RO4929097, bicalutamide
First posted: 2010-09-14
Last updated: 2017-12-02
Results first posted: 2014-10-23
Limitations and caveats: Early termination leading to small numbers of subjects analyzed.

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Time to PSA Progression	Up to 12 months	Time to PSA progression will be compared in the two groups using a log-rank test for a maximum of 54 weeks.
Secondary	Proportion of Patients Who Achieve Complete Response (by PSA) During the Combination Phase	Up to 12 months
Secondary	Proportion of Patients With PSA Progression During the Combination Phase	Up to 12 months
Secondary	Time to PSA Nadir During the Combination Phase	Up to 12 months
Secondary	Time to PSA Progression During the Combination Phase	Up to 12 months
Secondary	Time to PSA Progression During the Observation Phase	Up to 12 months
Secondary	Proportion of Patients With PSA Progression During the Observation Phase	Up to 12 months
Secondary	Safety and Tolerability Assessed Using NCI CTCAE Version 4.0	Up to 12 months	Number of participants randomized to RO4929097 arm who experienced serious adverse events .

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time to PSA Progression	Up to 12 months	Data were not collected as the protocol was terminated early due to lack of study drug. Only three patients progressed during randomization phase.
SECONDARY	Proportion of Patients Who Achieve Complete Response (by PSA) During the Combination Phase	Up to 12 months	Data were not collected as study was terminated early due to lack of study drug. Only three patients started combination phase and were then removed from study due to lack of study drug.
SECONDARY	Proportion of Patients With PSA Progression During the Combination Phase	Up to 12 months	Data were not collected as study was terminated early due to lack of study drug. Only three patients started combination phase and were then removed from study due to lack of study drug.
SECONDARY	Time to PSA Nadir During the Combination Phase	Up to 12 months	Data were not collected as study was terminated early due to lack of study drug.
SECONDARY	Time to PSA Progression During the Combination Phase	Up to 12 months	Data were not collected as study was terminated early due to lack of study drug.
SECONDARY	Time to PSA Progression During the Observation Phase	Up to 12 months	Data were not collected as study was terminated early due to lack of study drug. No subjects entered the observation phase.
SECONDARY	Proportion of Patients With PSA Progression During the Observation Phase	Up to 12 months	Data were not collected as study was terminated early due to lack of study drug. No subjects entered the observation phase.
SECONDARY	Safety and Tolerability Assessed Using NCI CTCAE Version 4.0	Up to 12 months		participants	NUMBER

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Safety and Tolerability Assessed Using NCI CTCAE Version 4.0	Arm I		0		participants
Safety and Tolerability Assessed Using NCI CTCAE Version 4.0	Arm II		0		participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I - Placebo	5
Overall Study	STARTED	Arm II - RO4929097	5
Overall Study	COMPLETED	Arm I - Placebo	0
Overall Study	COMPLETED	Arm II - RO4929097	0
Overall Study	NOT COMPLETED	Arm I - Placebo	5
Overall Study	NOT COMPLETED	Arm II - RO4929097	5

Source ClinicalTrials.gov

Adverse events88

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Hyphosphatemia	Metabolism and nutrition disorders	Arm I - Placebo	0	5	0
other	Hyphosphatemia	Metabolism and nutrition disorders	Arm II - RO4929097	1	5	2
other	Headache	Nervous system disorders	Arm I - Placebo	0	5	0
other	Headache	Nervous system disorders	Arm II - RO4929097	1	5	1
other	lightheadedness	Nervous system disorders	Arm I - Placebo	0	5
other	lightheadedness	Nervous system disorders	Arm II - RO4929097	1	5	1
other	hot flashes	Vascular disorders	Arm I - Placebo	0	5	0
other	hot flashes	Vascular disorders	Arm II - RO4929097	2	5	3
other	constipation with blood	Gastrointestinal disorders	Arm I - Placebo	0	5	0
other	constipation with blood	Gastrointestinal disorders	Arm II - RO4929097	1	5	1

1 to 10 of 88Source ClinicalTrials.gov

See all 88 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I - Placebo
Total, all-cause mortality	Arm II - RO4929097
Total, other adverse events	Arm I - Placebo	5	5
Total, other adverse events	Arm II - RO4929097	4	5
Total, serious adverse events	Arm I - Placebo	0	5
Total, serious adverse events	Arm II - RO4929097	0	5

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm I vs Arm II: Safety and Tolerability Assessed Using NCI CTCAE Version 4.0	Trial comparisons
Arm II - RO4929097 vs Arm I - Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01200810

GET https://conductscience.org/api/trials/v1/NCT01200810/events?page=2

API reference For AI assistants