Trial · NCT01844817

Phase II Trial Of Gemcitabine Plus Nab-Paclitaxel +/- OGX-427 In Patients With Metastatic Pancreatic Cancer

NCT01844817, Phase 2, Completed, SCRI Development Innovations, LLC; results first posted 2017-05-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase II Trial Of Gemcitabine Plus Nab-Paclitaxel +/- OGX-427 In Patients With Metastatic Pancreatic Cancer. Trials, record NCT01844817. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01844817

On this page

Trial

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

Title: Phase II Trial Of Gemcitabine Plus Nab-Paclitaxel +/- OGX-427 In Patients With Metastatic Pancreatic Cancer
NCT number: NCT01844817
Status: Completed
Phases: Phase 2
Enrollment: 132 participants, actual
Lead sponsor: SCRI Development Innovations, LLC
Conditions: Pancreatic Cancer
Interventions: OGX-427, Placebo
First posted: 2013-05-01
Last updated: 2017-05-16
Results first posted: 2017-05-16

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Overall Survival	Up to 2 years	Overall survival defined as the time, in months, from date of randomization until date of death or date last known alive whichever comes first, assessed up to 2 years.
Secondary	Progression-Free Survival	Every 8 weeks up to 2 years	The time (in months) that patients are progression-free, assessed from date of randomization to date of first documented disease progression or date of death from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest (nadir) sum while on study (this includes the baseline sum if that is the smallest on study), or the appearance of one or more new lesions.
Secondary	Objective Response Rate	Every 8 weeks for up to 2 years	Objective response rate defined as the percent of patients having a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR=complete disappearance of all target lesions. PR=decrease in baseline of 30% or more of the diameter(s) of all target lesions.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival	Up to 2 years	Includes Intent-to-Treat Population: all subjects enrolled and randomized	months	MEDIAN
SECONDARY	Progression-Free Survival	Every 8 weeks up to 2 years	Intent-to-Treat Population: all subjects enrolled and randomized	months	MEDIAN
SECONDARY	Objective Response Rate	Every 8 weeks for up to 2 years	Includes Intent-to-Treat Population: all subjects enrolled and randomized	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Category	Value	Spread	Units
Overall Survival	OGX-427		5.3	95% Confidence Interval 3.2 to 7.0	months
Overall Survival	Placebo		6.9	95% Confidence Interval 5.8 to 9.3	months
Progression-Free Survival	OGX-427		2.7	95% Confidence Interval 2.2 to 3.7	months
Progression-Free Survival	Placebo		3.8	95% Confidence Interval 2.3 to 4.7	months
Objective Response Rate	OGX-427	PR	18		percentage of participants
Objective Response Rate	Placebo	PR	18		percentage of participants
Objective Response Rate	OGX-427	CR	0		percentage of participants
Objective Response Rate	Placebo	CR	0		percentage of participants

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Enrolled and Randomized	STARTED	OGX-427	66
Enrolled and Randomized	STARTED	Placebo	66
Enrolled and Randomized	COMPLETED	OGX-427	64
Enrolled and Randomized	COMPLETED	Placebo	63
Enrolled and Randomized	NOT COMPLETED	OGX-427	2
Enrolled and Randomized	NOT COMPLETED	Placebo	3
Treatment	STARTED	OGX-427	64
Treatment	STARTED	Placebo	63
Treatment	COMPLETED	OGX-427	0
Treatment	COMPLETED	Placebo	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events260

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
other	Anaemia	Blood and lymphatic system disorders	OGX-427	36	64
other	Anaemia	Blood and lymphatic system disorders	Placebo	40	63
other	Thrombocytopenia	Blood and lymphatic system disorders	OGX-427	27	64
other	Thrombocytopenia	Blood and lymphatic system disorders	Placebo	21	63
other	Neutropenia	Blood and lymphatic system disorders	OGX-427	18	64
other	Neutropenia	Blood and lymphatic system disorders	Placebo	21	63
other	Leukopenia	Blood and lymphatic system disorders	OGX-427	8	64
other	Leukopenia	Blood and lymphatic system disorders	Placebo	6	63
other	Nausea	Gastrointestinal disorders	OGX-427	34	64
other	Nausea	Gastrointestinal disorders	Placebo	40	63

1 to 10 of 260Source ClinicalTrials.gov

See all 260 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	OGX-427
Total, all-cause mortality	Placebo
Total, other adverse events	OGX-427	62	64
Total, other adverse events	Placebo	62	63
Total, serious adverse events	OGX-427	64	64
Total, serious adverse events	Placebo	63	63

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28935773	DERIVED

Source PubMed

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 comparisons1

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

Comparison
OGX-427 vs Placebo: serious adverse events

Source 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/NCT01844817

GET https://conductscience.org/api/trials/v1/NCT01844817/events?page=2

API reference For AI assistants