Trial · NCT02096354

A Phase 2 Randomized, Open-Label Study of RRx-001 vs Regorafenib in Subjects With Metastatic Colorectal Cancer

NCT02096354, Phase 2, Completed, EpicentRx, Inc.; results first posted 2024-10-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase 2 Randomized, Open-Label Study of RRx-001 vs Regorafenib in Subjects With Metastatic Colorectal Cancer. Trials, record NCT02096354. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02096354

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Trial

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

Title: A Phase 2 Randomized, Open-Label Study of RRx-001 vs Regorafenib in Subjects With Metastatic Colorectal Cancer
NCT number: NCT02096354
Status: Completed
Phases: Phase 2
Enrollment: 62 participants, actual
Lead sponsor: EpicentRx, Inc.
Conditions: Colorectal Neoplasms
Interventions: RRx-001, Regorafenib, Irinotecan
First posted: 2014-03-26
Last updated: 2024-10-15
Results first posted: 2024-10-15

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Overall Survival	From date of enrollment until death or censorship.	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 47 months
Secondary	Progression Free Survival	Baseline, every 6-8 weeks while on study.	Progression-free survival (PFS) will be defined as the elapsed time from the from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 77 months
Secondary	Number of Adverse Events	Baseline through end of treatment (28 days after last dose of study drug). Approximately 24 weeks.	Incidence of related Adverse Events (AEs). SAEs and all other non-serious AEs are located in the Reported Adverse Event Module. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 is used to grade adverse events.
Secondary	Objective Response Rate	Up to 2 years	Percentage of participants with ORR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target and non-target disease. PR applied only to participants with at least one measurable lesion. Greater than or equal to 30 % decrease under baseline of the sum of longest diameters of all target measurable lesions.
Secondary	Clinical Benefit Rate	Up to 2 years	The period from study entry through Disease Control. Disease Control Rate (DCR) also correlates to Clinical Benefit Rate (CBR), defined as the percentage of subjects with CR, PR or SD relative to the total number of treated subjects

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Overall Survival	From date of enrollment until death or censorship.	months	MEDIAN
SECONDARY	Progression Free Survival	Baseline, every 6-8 weeks while on study.	months	MEDIAN
SECONDARY	Number of Adverse Events	Baseline through end of treatment (28 days after last dose of study drug). Approximately 24 weeks.	Number of total adverse events	NUMBER
SECONDARY	Objective Response Rate	Up to 2 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Clinical Benefit Rate	Up to 2 years	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group24

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

Outcome	Group	Category	Value	Spread	Units
Overall Survival	RRx-001 Followed by Irinotecan		8.6	95% Confidence Interval 4.8 to NA	months
Overall Survival	Regorafenib Followed by Irinotecan		4.7	95% Confidence Interval 2.2 to NA	months
Progression Free Survival	RRx-001 Followed by Irinotecan		6.1	95% Confidence Interval 3.7 to NA	months
Progression Free Survival	Regorafenib Followed by Irinotecan		1.7	95% Confidence Interval 0.7 to NA	months
Number of Adverse Events	RRx-001 Followed by Irinotecan	CTCAE Grade 1	184		Number of total adverse events
Number of Adverse Events	Regorafenib Followed by Irinotecan	CTCAE Grade 1	87		Number of total adverse events
Number of Adverse Events	RRx-001 Followed by Irinotecan	CTCAE Grade 2	76		Number of total adverse events
Number of Adverse Events	Regorafenib Followed by Irinotecan	CTCAE Grade 2	48		Number of total adverse events
Number of Adverse Events	RRx-001 Followed by Irinotecan	CTCAE Grade 3	15		Number of total adverse events
Number of Adverse Events	Regorafenib Followed by Irinotecan	CTCAE Grade 3	15		Number of total adverse events

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	RRx-001 Followed by Irinotecan	38
Overall Study	STARTED	Regorafenib Followed by Irinotecan	13
Overall Study	STARTED	Not Randomized	11
Overall Study	COMPLETED	RRx-001 Followed by Irinotecan	24
Overall Study	COMPLETED	Regorafenib Followed by Irinotecan	3
Overall Study	COMPLETED	Not Randomized	0
Overall Study	NOT COMPLETED	RRx-001 Followed by Irinotecan	14
Overall Study	NOT COMPLETED	Regorafenib Followed by Irinotecan	10
Overall Study	NOT COMPLETED	Not Randomized	11

Source ClinicalTrials.gov

Adverse events172

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	Abdominal pain	Gastrointestinal disorders	RRx-001 Followed by Irinotecan	9	38	10
other	Abdominal pain	Gastrointestinal disorders	Regorafenib Followed by Irinotecan	6	13	7
other	Enterovesical fistula	Gastrointestinal disorders	RRx-001 Followed by Irinotecan	2	38	8
other	Enterovesical fistula	Gastrointestinal disorders	Regorafenib Followed by Irinotecan	0	13	0
other	Intestinal obstruction	Gastrointestinal disorders	RRx-001 Followed by Irinotecan	0	38	0
other	Intestinal obstruction	Gastrointestinal disorders	Regorafenib Followed by Irinotecan	1	13	1
other	Small intestinal obstruction	Gastrointestinal disorders	RRx-001 Followed by Irinotecan	4	38	17
other	Small intestinal obstruction	Gastrointestinal disorders	Regorafenib Followed by Irinotecan	0	13	0
other	Stomatitis	Gastrointestinal disorders	RRx-001 Followed by Irinotecan	0	38	0
other	Stomatitis	Gastrointestinal disorders	Regorafenib Followed by Irinotecan	1	13	1

1 to 10 of 172Source ClinicalTrials.gov

See all 172 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	RRx-001 Followed by Irinotecan	3	38
Total, all-cause mortality	Regorafenib Followed by Irinotecan	1	13
Total, other adverse events	RRx-001 Followed by Irinotecan	19	38
Total, other adverse events	Regorafenib Followed by Irinotecan	10	13
Total, serious adverse events	RRx-001 Followed by Irinotecan	14	38
Total, serious adverse events	Regorafenib Followed by Irinotecan	7	13

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
24575021	RESULT	PubMed
28162292	BACKGROUND	PubMed
31250159	BACKGROUND	PubMed
36529613	RESULT	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 comparisons3

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

Comparison	Source
RRx-001 Followed by Irinotecan vs Regorafenib Followed by Irinotecan: Clinical Benefit Rate	Trial comparisons
RRx-001 Followed by Irinotecan vs Regorafenib Followed by Irinotecan: deaths from any cause	Trial comparisons
RRx-001 Followed by Irinotecan vs Regorafenib Followed by Irinotecan: 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/NCT02096354

GET https://conductscience.org/api/trials/v1/NCT02096354/results?page=2

API reference For AI assistants