Trial · NCT05983367

A Study to Investigate Ompenaclid Combined With FOLFIRI Plus Bevacizumab in Advanced/Metastatic Colorectal Cancer

NCT05983367, Phase 2, Terminated, Inspirna, Inc.; results first posted 2026-02-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Investigate Ompenaclid Combined With FOLFIRI Plus Bevacizumab in Advanced/Metastatic Colorectal Cancer. Trials, record NCT05983367. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05983367

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Trial

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

Title: A Study to Investigate Ompenaclid Combined With FOLFIRI Plus Bevacizumab in Advanced/Metastatic Colorectal Cancer
NCT number: NCT05983367
Status: Terminated
Phases: Phase 2
Enrollment: 76 participants, actual
Lead sponsor: Inspirna, Inc.
Conditions: Colorectal Cancer, Metastatic Colon Cancer
Interventions: Ompenaclid, Placebo, Bevacizumab, FOLFIRI regimen
First posted: 2023-08-09
Last updated: 2026-02-20
Results first posted: 2026-02-20

Source ClinicalTrials.gov

Registered outcomes9

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

List	Outcome	Time frame	Description
Primary	Objective Response Rate	From randomization until development of radiographic disease progression (up to approximately 12 months).	ORR is defined as the proportion of patients achieving a best overall response (BOR) of complete response (CR) or partial response (PR) per the investigators using RECIST version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Secondary	Progression-Free Survival (PFS)	From randomization until development of radiographic disease progression or death due to any cause, whichever comes first.	PFS is defined as the time from the date of randomization to the date of objectively determined progressive disease (PD) per the investigators using RECIST version 1.1 or death from any cause, whichever occurs first (up to approximately 12 months).
Secondary	Overall Survival (OS)	From randomization until death due to any cause.	OS is defined as the time from the date of randomization to the date of death from any cause. The proportions of participants who have not experienced OS events (death) at 9 months and 12 months are presented.
Secondary	Duration of Response (DoR)	From randomization until development of radiographic disease progression or death due to any cause, whichever comes first (up to approximately 12 months).	DoR is defined as the time from the date of objectively determined PR or CR (whichever status is recorded first) to the date of PD per the investigators using RECIST version 1.1 or death from any cause, whichever occurs first. The median DoR was not reached in both groups.
Secondary	Disease Control Rate (DCR)	From randomization until development of radiographic disease progression (up to approximately 12 months).	DCR is defined as the proportion of patients achieving a BOR of CR, PR, or stable disease (SD).
Secondary	Frequency of Adverse Events (AEs)	From the signing of informed consent until 30 days (+/- 3 days) after the last dose of study drug (up to approximately 12 months).	Percentage of patients with treatment-emergent AEs (TEAE).
Secondary	Pharmacokinetics of Ompenaclid	At Cycle 1 day 15 and Cycle 2 day 15 (each cycle is 28 days in length)	Steady state concentration of ompenaclid.
Secondary	Exploratory Biomarkers That May Correlate With Efficacy Outcomes	At baseline	Creatine kinase B (CKB) levels identified in baseline tumor tissue samples analyzed retrospectively.
Secondary	Progression-Free Survival (PFS) Rate at 6 and 9 Months	From randomization until development of radiographic disease progression or death due to any cause, whichever comes first.	PFS is defined as the time from the date of randomization to the date of objectively determined progressive disease (PD) per the investigators using RECIST version 1.1 or death from any cause, whichever occurs first. The proportions of participants who have not experienced PFS events (radiological disease progression or death) at 6 months and 9 months are presented.

Source ClinicalTrials.gov

Outcomes9

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Objective Response Rate	From randomization until development of radiographic disease progression (up to approximately 12 months).	All randomized participants (ITT: N=38 in each group), prior bevacizumab treated (N=27 in each group), prior bevacizumab untreated (N=11 in each group)	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Progression-Free Survival (PFS)	From randomization until development of radiographic disease progression or death due to any cause, whichever comes first.	All randomized participants (ITT: N=38 in each group)	Months	MEDIAN
SECONDARY	Overall Survival (OS)	From randomization until death due to any cause.	All randomized participants (ITT: N=38 in each group)	Percentage of participants	NUMBER
SECONDARY	Duration of Response (DoR)	From randomization until development of radiographic disease progression or death due to any cause, whichever comes first (up to approximately 12 months).		Months	MEDIAN
SECONDARY	Disease Control Rate (DCR)	From randomization until development of radiographic disease progression (up to approximately 12 months).	All randomized participants (ITT: N=38 in each group)	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Frequency of Adverse Events (AEs)	From the signing of informed consent until 30 days (+/- 3 days) after the last dose of study drug (up to approximately 12 months).	The safety analysis set comprised all patients who received at least one dose of ompenaclid or matching placebo (N=75). One patient in the ompenaclid group was excluded from the safety analysis set as the patient was randomized but did not receive the study treatment due to poor cardiac function and not meeting one of the inclusion criteria.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Pharmacokinetics of Ompenaclid	At Cycle 1 day 15 and Cycle 2 day 15 (each cycle is 28 days in length)	Ompenaclid pharmacokinetics was assessed in ompenaclid arm only.	Mean concentration (ng/mL)	MEAN
SECONDARY	Exploratory Biomarkers That May Correlate With Efficacy Outcomes	At baseline
SECONDARY	Progression-Free Survival (PFS) Rate at 6 and 9 Months	From randomization until development of radiographic disease progression or death due to any cause, whichever comes first.	All randomized participants (ITT: N=38 in each group)	Percentage of participants	NUMBER

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
Objective Response Rate	Ompenaclid + FOLFIRI + Bevacizumab	All randomized participants	8		Participants
Objective Response Rate	Placebo + FOLFIRI + Bevacizumab	All randomized participants	8		Participants
Objective Response Rate	Ompenaclid + FOLFIRI + Bevacizumab	Participants treated with prior bevacizumab	2		Participants
Objective Response Rate	Placebo + FOLFIRI + Bevacizumab	Participants treated with prior bevacizumab	4		Participants
Objective Response Rate	Ompenaclid + FOLFIRI + Bevacizumab	Participants untreated with prior bevacizumab	6		Participants
Objective Response Rate	Placebo + FOLFIRI + Bevacizumab	Participants untreated with prior bevacizumab	4		Participants
Progression-Free Survival (PFS)	Ompenaclid + FOLFIRI + Bevacizumab		8.8	90% Confidence Interval 5.72 to 11.10	Months
Progression-Free Survival (PFS)	Placebo + FOLFIRI + Bevacizumab		8.1	90% Confidence Interval 5.55 to 10.94	Months
Overall Survival (OS)	Ompenaclid + FOLFIRI + Bevacizumab	OS rate at 9 months	88.5	90% Confidence Interval 79.5052 to 97.4717	Percentage of participants
Overall Survival (OS)	Placebo + FOLFIRI + Bevacizumab	OS rate at 9 months	69.0	90% Confidence Interval 55.3450 to 82.6884	Percentage of participants

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ompenaclid + FOLFIRI + Bevacizumab	38
Overall Study	STARTED	Placebo + FOLFIRI + Bevacizumab	38
Overall Study	COMPLETED	Ompenaclid + FOLFIRI + Bevacizumab	36
Overall Study	COMPLETED	Placebo + FOLFIRI + Bevacizumab	36
Overall Study	NOT COMPLETED	Ompenaclid + FOLFIRI + Bevacizumab	2
Overall Study	NOT COMPLETED	Placebo + FOLFIRI + Bevacizumab	2

Source ClinicalTrials.gov

Adverse events218

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	Diarrhoea	Gastrointestinal disorders	Ompenaclid + FOLFIRI + Bevacizumab	24	37
other	Diarrhoea	Gastrointestinal disorders	Placebo + FOLFIRI + Bevacizumab	32	38
other	Nausea	Gastrointestinal disorders	Ompenaclid + FOLFIRI + Bevacizumab	27	37
other	Nausea	Gastrointestinal disorders	Placebo + FOLFIRI + Bevacizumab	18	38
other	Vomiting	Gastrointestinal disorders	Ompenaclid + FOLFIRI + Bevacizumab	22	37
other	Vomiting	Gastrointestinal disorders	Placebo + FOLFIRI + Bevacizumab	14	38
other	Stomatitis	Gastrointestinal disorders	Ompenaclid + FOLFIRI + Bevacizumab	14	37
other	Stomatitis	Gastrointestinal disorders	Placebo + FOLFIRI + Bevacizumab	13	38
other	Constipation	Gastrointestinal disorders	Ompenaclid + FOLFIRI + Bevacizumab	5	37
other	Constipation	Gastrointestinal disorders	Placebo + FOLFIRI + Bevacizumab	10	38

1 to 10 of 218Source ClinicalTrials.gov

See all 218 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ompenaclid + FOLFIRI + Bevacizumab	4	38
Total, all-cause mortality	Placebo + FOLFIRI + Bevacizumab	11	38
Total, other adverse events	Ompenaclid + FOLFIRI + Bevacizumab	37	37
Total, other adverse events	Placebo + FOLFIRI + Bevacizumab	38	38
Total, serious adverse events	Ompenaclid + FOLFIRI + Bevacizumab	12	37
Total, serious adverse events	Placebo + FOLFIRI + Bevacizumab	9	38

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 comparisons4

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

Comparison	Source
Ompenaclid + FOLFIRI + Bevacizumab vs Placebo + FOLFIRI + Bevacizumab: Disease Control Rate (DCR)	Trial comparisons
Ompenaclid + FOLFIRI + Bevacizumab vs Placebo + FOLFIRI + Bevacizumab: Frequency of Adverse Events (AEs)	Trial comparisons
Ompenaclid + FOLFIRI + Bevacizumab vs Placebo + FOLFIRI + Bevacizumab: deaths from any cause	Trial comparisons
Ompenaclid + FOLFIRI + Bevacizumab vs Placebo + FOLFIRI + Bevacizumab: 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/NCT05983367

GET https://conductscience.org/api/trials/v1/NCT05983367/results?page=2

API reference For AI assistants