Trial · NCT02757326

ABC294640 (Opaganib) in Refractory / Relapsed Multiple Myeloma

NCT02757326, Phase 1, Phase 2, Terminated, RedHill Biopharma Limited; results first posted 2021-06-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. ABC294640 (Opaganib) in Refractory / Relapsed Multiple Myeloma. Trials, record NCT02757326. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02757326

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Trial

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

Title: ABC294640 (Opaganib) in Refractory / Relapsed Multiple Myeloma
NCT number: NCT02757326
Status: Terminated
Phases: Phase 1, Phase 2
Enrollment: 13 participants, actual
Lead sponsor: RedHill Biopharma Limited
Conditions: Multiple Myeloma
Interventions: Opaganib
First posted: 2016-05-02
Last updated: 2021-06-18
Results first posted: 2021-06-18

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Maximum Tolerated Dose	6 months	Evaluation of three doses of opaganib - 250 mg bid, 500 mg bid and 750 mg bid to determine the maximum tolerated dose (MTD) based upon the dose limiting toxicity (DLT) using a Bayesian model averaging continual reassessment method and is the dose at which the estimated probability of toxicity is closest to the target probability 0.33 among all doses.
Secondary	To Assess the Antitumor Activity of Single Agent Opaganib in Patients With Refractory or Relapsed Multiple Myeloma After 3 Cycles of Treatment.	After 3 cycles (12 weeks) of treatment	Stable disease, partial response, complete response or disease progression.
Secondary	Number of Patients With Dose Limiting Toxicity	12 months	For the phase 1b portion of the trial, a dose-limiting toxicity (DLT) was defined as an adverse event at least possibly related to the study medication: Non-hematologic DLT is defined as any Grade 3 or greater ADR (adverse drug reaction), except symptomatic AEs such as nausea, vomiting, and diarrhea which could be reduced to less than Grade 3 within 72 hours with standard supportive measures (i.e., antiemetics and antidiarrheals). Hematologic DLT is defined as * Grade 4 neutropenia or thrombocytopenia that lasts more than 7 days after the last dose of study drug * or greater than or equal to Grade 3 thrombocytopenia in the presence of greater than or equal to Grade 3 hemorrhage of any organ/site * or any Grade 5 hematologic toxicity
Secondary	Maximum Concentration (Cmax) of ABC294640	8 hours	To determine the Cmax of ABC294640 following administration of the drug.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maximum Tolerated Dose	6 months	Safety population	mg	NUMBER
SECONDARY	To Assess the Antitumor Activity of Single Agent Opaganib in Patients With Refractory or Relapsed Multiple Myeloma After 3 Cycles of Treatment.	After 3 cycles (12 weeks) of treatment	Intent to treat	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Patients With Dose Limiting Toxicity	12 months	All participants receiving any amount of study drug	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Maximum Concentration (Cmax) of ABC294640	8 hours		mcg/hr/mL	MEAN

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Value	Spread	Units
Maximum Tolerated Dose	Opaganib	NA		mg
To Assess the Antitumor Activity of Single Agent Opaganib in Patients With Refractory or Relapsed Multiple Myeloma After 3 Cycles of Treatment.	ABC294640 250 mg BID	0		Participants
To Assess the Antitumor Activity of Single Agent Opaganib in Patients With Refractory or Relapsed Multiple Myeloma After 3 Cycles of Treatment.	ABC294640 500 mg BID	2		Participants
To Assess the Antitumor Activity of Single Agent Opaganib in Patients With Refractory or Relapsed Multiple Myeloma After 3 Cycles of Treatment.	ABC294640 750 mg BID	0		Participants
Number of Patients With Dose Limiting Toxicity	ABC294640 250 mg BID	0		Participants
Number of Patients With Dose Limiting Toxicity	ABC294640 500 mg BID	0		Participants
Number of Patients With Dose Limiting Toxicity	ABC294640 750 mg BID	1		Participants
Maximum Concentration (Cmax) of ABC294640	ABC294640 250 mg BID	5.6	Standard Deviation 1.7	mcg/hr/mL
Maximum Concentration (Cmax) of ABC294640	ABC294640 500 mg BID	12.5	Standard Deviation 2.5	mcg/hr/mL
Maximum Concentration (Cmax) of ABC294640	ABC294640 750 mg BID	25.8	Standard Deviation 3	mcg/hr/mL

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	250 mg	3
Overall Study	STARTED	500 mg	4
Overall Study	STARTED	750 mg	6
Overall Study	COMPLETED	250 mg	3
Overall Study	COMPLETED	500 mg	4
Overall Study	COMPLETED	750 mg	6
Overall Study	NOT COMPLETED	250 mg	0
Overall Study	NOT COMPLETED	500 mg	0
Overall Study	NOT COMPLETED	750 mg	0

Source ClinicalTrials.gov

Adverse events234

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	Summary of Adverse events occurring in >10% of patients by System Organ Class and Preferred Term	Blood and lymphatic system disorders	250 mg Phase 1b	3	3	28
other	Summary of Adverse events occurring in >10% of patients by System Organ Class and Preferred Term	Blood and lymphatic system disorders	500 mg Phase 1b	4	4	34
other	Summary of Adverse events occurring in >10% of patients by System Organ Class and Preferred Term	Blood and lymphatic system disorders	750 mg Phase 1b	6	6	41
other	Hypokalaemia	Metabolism and nutrition disorders	250 mg Phase 1b	1	3	1
other	Hypokalaemia	Metabolism and nutrition disorders	500 mg Phase 1b	1	4	1
other	Hypokalaemia	Metabolism and nutrition disorders	750 mg Phase 1b	3	6	3
other	Hyponatraemia	Metabolism and nutrition disorders	250 mg Phase 1b	1	3	1
other	Hyponatraemia	Metabolism and nutrition disorders	500 mg Phase 1b	2	4	2
other	Hyponatraemia	Metabolism and nutrition disorders	750 mg Phase 1b	2	6	2
other	Hypophosphataemia	Metabolism and nutrition disorders	250 mg Phase 1b	1	3	1

1 to 10 of 234Source ClinicalTrials.gov

See all 234 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	250 mg Phase 1b	0	3
Total, all-cause mortality	500 mg Phase 1b	0	4
Total, all-cause mortality	750 mg Phase 1b	0	6
Total, other adverse events	250 mg Phase 1b	3	3
Total, other adverse events	500 mg Phase 1b	4	4
Total, other adverse events	750 mg Phase 1b	6	6
Total, serious adverse events	250 mg Phase 1b	1	3
Total, serious adverse events	500 mg Phase 1b	3	4
Total, serious adverse events	750 mg Phase 1b	1	6

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25122609	BACKGROUND	PubMed
36460794	DERIVED	PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R44CA199767	Clinical Trial of ABC294640 in Patients with Refractory Multiple Myeloma	SMITH, CHARLES D	APOGEE BIOTECHNOLOGY CORPORATION	NATIONAL CANCER INSTITUTE	2015 to 2017

Source NIH RePORTER

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/NCT02757326

GET https://conductscience.org/api/trials/v1/NCT02757326/events?page=2

API reference For AI assistants