Trial · NCT01746979

Clinical Trial Testing TH-302 in Combination With Gemcitabine in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma

NCT01746979, Phase 3, Completed, ImmunoGenesis; results first posted 2017-12-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Clinical Trial Testing TH-302 in Combination With Gemcitabine in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma. Trials, record NCT01746979. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01746979

On this page

Trial

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

Title: Clinical Trial Testing TH-302 in Combination With Gemcitabine in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma
NCT number: NCT01746979
Status: Completed
Phases: Phase 3
Enrollment: 693 participants, actual
Lead sponsor: ImmunoGenesis
Conditions: Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma
Interventions: TH-302, Gemcitabine, Placebo (5 percent dextrose - D5W)
First posted: 2012-12-11
Last updated: 2025-05-11
Other registries' IDs: eudract:2012-002957-42
Results first posted: 2017-12-02

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Overall Survival	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years	Overall survival is defined as time from randomization to death or last day known to be alive.
Secondary	Progression Free Survival	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years	Progression Free Survival is defined as the time from randomization to either first observation of progressive disease or occurrence of death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years		months	MEDIAN
SECONDARY	Progression Free Survival	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years		months	MEDIAN

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
Overall Survival	Gemcitabine Plus TH-302	8.9	95% Confidence Interval 7.6 to 9.9	months
Overall Survival	Gemcitabine Plus Placebo	7.6	95% Confidence Interval 6.7 to 8.3	months
Progression Free Survival	Gemcitabine Plus TH-302	5.5	95% Confidence Interval 4.8 to 5.6	months
Progression Free Survival	Gemcitabine Plus Placebo	3.7	95% Confidence Interval 3.6 to 3.8	months

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Gemcitabine Plus TH-302	346
Overall Study	STARTED	Gemcitabine Plus Placebo	347
Overall Study	COMPLETED	Gemcitabine Plus TH-302	0
Overall Study	COMPLETED	Gemcitabine Plus Placebo	0
Overall Study	NOT COMPLETED	Gemcitabine Plus TH-302	346
Overall Study	NOT COMPLETED	Gemcitabine Plus Placebo	347

Source ClinicalTrials.gov

Adverse events548

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	Anaemia	Blood and lymphatic system disorders	TH-302	108	341	254
other	Anaemia	Blood and lymphatic system disorders	Placebo	164	338	582
other	Leukopenia	Blood and lymphatic system disorders	TH-302	29	341	47
other	Leukopenia	Blood and lymphatic system disorders	Placebo	47	338	198
other	Neutropenia	Blood and lymphatic system disorders	TH-302	94	341	248
other	Neutropenia	Blood and lymphatic system disorders	Placebo	140	338	546
other	Thrombocytopenia	Blood and lymphatic system disorders	TH-302	61	341	151
other	Thrombocytopenia	Blood and lymphatic system disorders	Placebo	158	338	772
other	Decreased appetite	Metabolism and nutrition disorders	TH-302	116	341	184
other	Decreased appetite	Metabolism and nutrition disorders	Placebo	117	338	205

1 to 10 of 548Source ClinicalTrials.gov

See all 548 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	TH-302
Total, all-cause mortality	Placebo
Total, other adverse events	TH-302	341	341
Total, other adverse events	Placebo	338	338
Total, serious adverse events	TH-302	341	341
Total, serious adverse events	Placebo	338	338

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25512461	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
TH-302 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/NCT01746979

GET https://conductscience.org/api/trials/v1/NCT01746979/events?page=2

API reference For AI assistants