Trial · NCT01828476

Navitoclax and Abiraterone Acetate With or Without Hydroxychloroquine in Treating Patients With Progressive Metastatic Castrate Refractory Prostate Cancer

NCT01828476, Phase 2, Terminated, Rutgers, The State University of New Jersey; results first posted 2017-03-31

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Navitoclax and Abiraterone Acetate With or Without Hydroxychloroquine in Treating Patients With Progressive Metastatic Castrate Refractory Prostate Cancer. Trials, record NCT01828476. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01828476

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Trial

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

Title: Navitoclax and Abiraterone Acetate With or Without Hydroxychloroquine in Treating Patients With Progressive Metastatic Castrate Refractory Prostate Cancer
NCT number: NCT01828476
Status: Terminated
Phases: Phase 2
Enrollment: 13 participants, actual
Lead sponsor: Rutgers, The State University of New Jersey
Conditions: Prostate Cancer
Interventions: Abiraterone, ABT-263, Hydroxychloroquine
First posted: 2013-04-10
Last updated: 2017-05-04
Results first posted: 2017-03-31

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Biochemical Response to ABT-263 and Abiraterone and to ABT-263 in Combination With Hydroxychloroquine and Abiraterone in Patients That Are Progressing on Abiraterone	5 years	Characterize "biochemical response" to ABT-263 and Abiraterone and to ABT-263 in combination with hydroxychloroquine and Abiraterone by looking at PSA levels.
Secondary	Time to PSA Progression	5 years
Secondary	Progression Free Survival	5 years
Secondary	Measurable Tumor Response in Patients With Measurable Disease	5 years
Secondary	Circulating Tumor Cells Pre-enrollment and During Therapy	5 years
Secondary	Bcl-2 Family Protein Expression (Bcl-2, Bcl-XL, MCL-1) in Paraffin Blocks When Available by Immunohistochemistry	5 years
Secondary	Biomarkers of Autophagy Modulation by EM; and LC3, and/or p62 by Immunoblotting in PBMC and Tumor Tissue When Available	5 years
Secondary	Overall Survival	5 years

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	Biochemical Response to ABT-263 and Abiraterone and to ABT-263 in Combination With Hydroxychloroquine and Abiraterone in Patients That Are Progressing on Abiraterone	5 years	Study was terminated early and insufficient data was collected to assess this outcome measure.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Time to PSA Progression	5 years	Study was terminated early and insufficient data were collected to assess this outcome measure.
SECONDARY	Progression Free Survival	5 years	Study was terminated early and insufficient data were collected to assess this outcome measure.
SECONDARY	Measurable Tumor Response in Patients With Measurable Disease	5 years	Study was terminated early and insufficent data was collected to assess this outcome measure.
SECONDARY	Circulating Tumor Cells Pre-enrollment and During Therapy	5 years	Study was terminated early and insufficient data was collected to assess this outcome measure.
SECONDARY	Bcl-2 Family Protein Expression (Bcl-2, Bcl-XL, MCL-1) in Paraffin Blocks When Available by Immunohistochemistry	5 years	Study was terminated warly and insufficient data was collected to assess this outcome measure.
SECONDARY	Biomarkers of Autophagy Modulation by EM; and LC3, and/or p62 by Immunoblotting in PBMC and Tumor Tissue When Available	5 years	Study was terminated early and insufficient data was collected to assess this outcome measure.
SECONDARY	Overall Survival	5 years	Study was terminated early and insufficient data was collected to assess this outcome measure.

Source ClinicalTrials.gov

Results by group15

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

Outcome	Group	Units
Biochemical Response to ABT-263 and Abiraterone and to ABT-263 in Combination With Hydroxychloroquine and Abiraterone in Patients That Are Progressing on Abiraterone	ARM A	Participants
Time to PSA Progression	ARM A
Time to PSA Progression	ARM B
Progression Free Survival	ARM A - Dose Escalation
Progression Free Survival	ARM B - Dose Escalation
Measurable Tumor Response in Patients With Measurable Disease	ARM A
Measurable Tumor Response in Patients With Measurable Disease	ARM B
Circulating Tumor Cells Pre-enrollment and During Therapy	ARM A
Circulating Tumor Cells Pre-enrollment and During Therapy	ARM B
Bcl-2 Family Protein Expression (Bcl-2, Bcl-XL, MCL-1) in Paraffin Blocks When Available by Immunohistochemistry	ARM A

1 to 10 of 15Source ClinicalTrials.gov

See all 15 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	ARM A - Dose Escalation	13
Overall Study	STARTED	ARM B - Dose Escalation	0
Overall Study	COMPLETED	ARM A - Dose Escalation	13
Overall Study	COMPLETED	ARM B - Dose Escalation	0
Overall Study	NOT COMPLETED	ARM A - Dose Escalation	0
Overall Study	NOT COMPLETED	ARM B - Dose Escalation	0

Source ClinicalTrials.gov

Adverse events36

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	Nausea	Gastrointestinal disorders	ARM A - Dose Escalation	3	13	4
other	Nausea	Gastrointestinal disorders	ARM B - Dose Escalation	0	0	0
other	Diarrhea	Gastrointestinal disorders	ARM A - Dose Escalation	3	13	13
other	Diarrhea	Gastrointestinal disorders	ARM B - Dose Escalation	0	0	0
other	Platelet count decreased	Investigations	ARM A - Dose Escalation	11	13	27
other	Platelet count decreased	Investigations	ARM B - Dose Escalation	0	0	0
other	Neutrophil count decreased	Investigations	ARM A - Dose Escalation	6	13	19
other	Neutrophil count decreased	Investigations	ARM B - Dose Escalation	0	0	0
other	Anemia	Blood and lymphatic system disorders	ARM A - Dose Escalation	3	13	5
other	Anemia	Blood and lymphatic system disorders	ARM B - Dose Escalation	0	0	0

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ARM A - Dose Escalation	0	13
Total, all-cause mortality	ARM B - Dose Escalation	0	0
Total, other adverse events	ARM A - Dose Escalation	13	13
Total, other adverse events	ARM B - Dose Escalation	0	0
Total, serious adverse events	ARM A - Dose Escalation	1	13
Total, serious adverse events	ARM B - Dose Escalation	0	0

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA072720	Cancer Center Support Grant	LIBUTTI, STEVEN K.	RUTGERS BIOMEDICAL AND HEALTH SCIENCES	NATIONAL CANCER INSTITUTE	1997 to 2025

Source NIH RePORTER

Trial comparisons0

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

None in this release.

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/NCT01828476

GET https://conductscience.org/api/trials/v1/NCT01828476/events?page=2

API reference For AI assistants