Trial · NCT01124786

A Study Comparing CO-1.01 With Gemcitabine as First Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma (LEAP)

NCT01124786, Phase 2, Completed, Clovis Oncology, Inc.; results first posted 2014-04-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study Comparing CO-1.01 With Gemcitabine as First Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma (LEAP). Trials, record NCT01124786. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01124786

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Trial

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

Title: A Study Comparing CO-1.01 With Gemcitabine as First Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma (LEAP)
NCT number: NCT01124786
Status: Completed
Phases: Phase 2
Enrollment: 367 participants, actual
Lead sponsor: Clovis Oncology, Inc.
Conditions: Metastatic Pancreatic Adenocarcinoma
Interventions: CO-1.01, Gemcitabine
First posted: 2010-05-17
Last updated: 2014-04-17
Results first posted: 2014-04-17
Limitations and caveats: Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed. However, patient enrollment completed normally.

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame
Primary	Overall Survival in Patients With Low High Human Equilibrative Nucleoside Transporter 1 (hENT1) Expression	Monthly follow up after treatment discontinuation until death, up to 1.5 years.
Secondary	Overall Survival in All Patients and Patients With hENT1 Expression	Monthly follow up after treatment discontinuation until death, up to 1.5 years
Secondary	ORR, Duration of Response, and Progression Free Survival (PFS) in Patients With Measurable/Evaluable Disease, Using RECIST 1.1, up to 1.5 Years	Every 8 weeks
Secondary	Cancer Antigen (CA)19-9 Response Rates	Every 4 weeks, up to 1.5 years
Secondary	Drug Tolerability and Toxicity	Every week, up to 1.5 years
Secondary	Change From Baseline in Pain Severity	Every 4 weeks, up to 1.5 years
Secondary	Change From Baseline in Health Status	Every 4 weeks, up to 1.5 years
Secondary	Pharmacokinetic (PK) Profile of CO-1.01 Based on Sparse Sampling	30 days after first dose

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	Overall Survival in Patients With Low High Human Equilibrative Nucleoside Transporter 1 (hENT1) Expression	Monthly follow up after treatment discontinuation until death, up to 1.5 years.	Analysis was per protocol and included hENT-1 low Intent to Treat (IIT) population.	months	MEDIAN
SECONDARY	Overall Survival in All Patients and Patients With hENT1 Expression	Monthly follow up after treatment discontinuation until death, up to 1.5 years	Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.
SECONDARY	ORR, Duration of Response, and Progression Free Survival (PFS) in Patients With Measurable/Evaluable Disease, Using RECIST 1.1, up to 1.5 Years	Every 8 weeks	Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.
SECONDARY	Cancer Antigen (CA)19-9 Response Rates	Every 4 weeks, up to 1.5 years	Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.
SECONDARY	Drug Tolerability and Toxicity	Every week, up to 1.5 years	Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.
SECONDARY	Change From Baseline in Pain Severity	Every 4 weeks, up to 1.5 years	Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.
SECONDARY	Change From Baseline in Health Status	Every 4 weeks, up to 1.5 years	Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.
SECONDARY	Pharmacokinetic (PK) Profile of CO-1.01 Based on Sparse Sampling	30 days after first dose	Due to Primary endpoint showing lack of efficacy, development of CO-1.01 was stopped and secondary endpoints were not analyzed.

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
Overall Survival in Patients With Low High Human Equilibrative Nucleoside Transporter 1 (hENT1) Expression	CO-1.01		5.7	95% Confidence Interval 4.7 to 7.6	months
Overall Survival in Patients With Low High Human Equilibrative Nucleoside Transporter 1 (hENT1) Expression	Gemcitabine		6.1	95% Confidence Interval 5.2 to 7.7	months

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	CO-1.01	182
Overall Study	STARTED	Gemcitabine	185
Overall Study	Intent-to-Treat (ITT) Population	CO-1.01	182
Overall Study	Intent-to-Treat (ITT) Population	Gemcitabine	185
Overall Study	Safety Population	CO-1.01	179
Overall Study	Safety Population	Gemcitabine	181
Overall Study	Tumor Evaluable Population	CO-1.01	178
Overall Study	Tumor Evaluable Population	Gemcitabine	180
Overall Study	COMPLETED	CO-1.01	178
Overall Study	COMPLETED	Gemcitabine	180

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events312

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	Nausea	Gastrointestinal disorders	CO-1.01	70	179
other	Nausea	Gastrointestinal disorders	Gemcitabine	59	181
other	Anaemia	Blood and lymphatic system disorders	CO-1.01	65	179
other	Anaemia	Blood and lymphatic system disorders	Gemcitabine	78	181
other	Thrombocytopenia	Blood and lymphatic system disorders	CO-1.01	53	179
other	Thrombocytopenia	Blood and lymphatic system disorders	Gemcitabine	60	181
other	Asthenia	General disorders	CO-1.01	47	179
other	Asthenia	General disorders	Gemcitabine	34	181
other	Neutropenia	Blood and lymphatic system disorders	CO-1.01	46	179
other	Neutropenia	Blood and lymphatic system disorders	Gemcitabine	47	181

1 to 10 of 312Source ClinicalTrials.gov

See all 312 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	CO-1.01
Total, all-cause mortality	Gemcitabine
Total, other adverse events	CO-1.01	171	179
Total, other adverse events	Gemcitabine	164	181
Total, serious adverse events	CO-1.01	82	179
Total, serious adverse events	Gemcitabine	82	181

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 comparisons1

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

Comparison
CO-1.01 vs Gemcitabine: 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/NCT01124786

GET https://conductscience.org/api/trials/v1/NCT01124786/events?page=2

API reference For AI assistants