Trial · NCT02234986

A Multi-center, Open-label Study of Oral ENMD-2076 for the Treatment of Patients With Advanced Fibrolamellar Carcinoma

NCT02234986, Phase 2, Completed, CASI pharmaceuticals, Inc.; results first posted 2025-04-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Multi-center, Open-label Study of Oral ENMD-2076 for the Treatment of Patients With Advanced Fibrolamellar Carcinoma. Trials, record NCT02234986. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02234986

On this page

Trial

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

Title: A Multi-center, Open-label Study of Oral ENMD-2076 for the Treatment of Patients With Advanced Fibrolamellar Carcinoma
NCT number: NCT02234986
Status: Completed
Phases: Phase 2
Enrollment: 35 participants, actual
Lead sponsor: CASI pharmaceuticals, Inc.
Conditions: Advanced Adult Hepatocellular Carcinoma, Advanced Fibrolamellar Carcinoma
Interventions: ENMD-2076
First posted: 2014-09-09
Last updated: 2025-04-18
Results first posted: 2025-04-18

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Overall Response Rate	6 months	6-month overall response rate (ORR rate) using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) 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; ORR = proportion of patients evaluated as CR + PR
Secondary	Progression Free Survival	6 months	using RECIST v 1.1 criteria
Other	Frequency and Severity of Adverse Events	6 months	Frequency and severity of adverse events in patients evaluable for toxicity

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 Response Rate	6 months	Patients treated and evaluable for efficacy	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Progression Free Survival	6 months	patients treated and evaluable for efficacy	months	MEDIAN
OTHER_PRE_SPECIFIED	Frequency and Severity of Adverse Events	6 months	patients treated and evaluable for toxicity assessment; regardless of relationship to study medication according to CTCAE 5.0	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Category	Value	Spread	Units
Overall Response Rate	ENMD-2076	Partial response	1		Participants
Overall Response Rate	ENMD-2076	Stable disease	20		Participants
Overall Response Rate	ENMD-2076	Progressive disease	10		Participants
Overall Response Rate	ENMD-2076	Other / unknown	4		Participants
Progression Free Survival	ENMD-2076		3.9	95% Confidence Interval 2.3 to 5.5	months
Frequency and Severity of Adverse Events	ENMD-2076	Fatigue	27		Participants
Frequency and Severity of Adverse Events	ENMD-2076	ALT increased	26		Participants
Frequency and Severity of Adverse Events	ENMD-2076	AST increased	24		Participants
Frequency and Severity of Adverse Events	ENMD-2076	Abdominal pain	23		Participants
Frequency and Severity of Adverse Events	ENMD-2076	Diarrhea	23		Participants

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	ENMD-2076	35
Overall Study	COMPLETED	ENMD-2076	35
Overall Study	NOT COMPLETED	ENMD-2076	0

Source ClinicalTrials.gov

Adverse events67

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	Fatigue	General disorders	ENMD-2076	27	35	27
other	Fever	General disorders	ENMD-2076	3	35	3
other	Chills	General disorders	ENMD-2076	2	35	2
other	Nausea	Gastrointestinal disorders	ENMD-2076	20	35	20
other	Vomiting	Gastrointestinal disorders	ENMD-2076	9	35	9
other	Diarrhea	Gastrointestinal disorders	ENMD-2076	23	35	23
other	Constipation	Gastrointestinal disorders	ENMD-2076	8	35	8
other	Anemia	Blood and lymphatic system disorders	ENMD-2076	9	35	9
other	Decreased neutrophil count	Blood and lymphatic system disorders	ENMD-2076	2	35	2
other	Decreased platelet count	Investigations	ENMD-2076	5	35	5

1 to 10 of 67Source ClinicalTrials.gov

See all 67 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ENMD-2076	3	35
Total, other adverse events	ENMD-2076	35	35
Total, serious adverse events	ENMD-2076	4	35

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32154962	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 comparisons0

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

None in this release.

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/NCT02234986

GET https://conductscience.org/api/trials/v1/NCT02234986/events?page=2

API reference For AI assistants