Trial · NCT03512756

A Randomized Phase 2/3 Multi-Center Study of SM-88 in Participants With Metastatic Pancreatic Cancer

NCT03512756, Phase 2, Phase 3, Terminated, Tyme, Inc; results first posted 2024-11-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Randomized Phase 2/3 Multi-Center Study of SM-88 in Participants With Metastatic Pancreatic Cancer. Trials, record NCT03512756. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03512756

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Trial

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

Title: A Randomized Phase 2/3 Multi-Center Study of SM-88 in Participants With Metastatic Pancreatic Cancer
NCT number: NCT03512756
Status: Terminated
Phases: Phase 2, Phase 3
Enrollment: 130 participants, actual
Lead sponsor: Tyme, Inc
Conditions: Pancreatic Cancer
Interventions: SM-88 used with MPS (methoxsalen, phenytoin, sirolimus), Capecitabine, Gemcitabine, and 5-FU
First posted: 2018-05-01
Last updated: 2024-11-06
Results first posted: 2024-11-06

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Overall Survival (OS)	Up to 12 months	OS was defined as the number of days between the first study drug administration and death from any cause. Results are reported in weeks.
Secondary	Progression Free Survival (PFS)	Up to 12 months	Progression-Free Survival (PFS), is defined as the time from randomization to first documentation of objective tumor progression (progressive disease) or death due to any reasons whichever comes first. Disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Results are reported in weeks.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival (OS)	Up to 12 months	Evaluable Population included all participants enrolled in the study who received at least 1 cycle (28 days) of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this Outcome Measure.	Weeks	MEDIAN
SECONDARY	Progression Free Survival (PFS)	Up to 12 months	Intent to Treat (ITT) Population included all participants who consented in the study and randomized to treatment, and assigned to treatment they were randomized to. Here, 'Overall number of participants analyzed' = participants evaluable for this Outcome Measure.	Weeks	MEDIAN

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Overall Survival (OS)	Part 1: SM-88 460 mg	21.3	95% Confidence Interval 9.7 to 35.0	Weeks
Overall Survival (OS)	Part 1: SM-88 920 mg	15.7	95% Confidence Interval 11.1 to 24.7	Weeks
Overall Survival (OS)	Part 2: SM-88 920 mg	14.0	95% Confidence Interval 11.1 to 19.4	Weeks
Overall Survival (OS)	Part 2: Physician's Choice	24.1	95% Confidence Interval 13.7 to 31.6	Weeks
Progression Free Survival (PFS)	Part 1: SM-88 460 mg	8.0	95% Confidence Interval 7.1 to 8.6	Weeks
Progression Free Survival (PFS)	Part 1: SM-88 920 mg	8.0	95% Confidence Interval 5.6 to 11.1	Weeks
Progression Free Survival (PFS)	Part 2: SM-88 920 mg	7.7	95% Confidence Interval 5.6 to 8.0	Weeks
Progression Free Survival (PFS)	Part 2: Physician's Choice	8.9	95% Confidence Interval 6.0 to 12.7	Weeks

Source ClinicalTrials.gov

Participant flow32

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

Period	Milestone	Group	Participants
Part 1	STARTED	Part 1: SM-88 460 Milligrams (mg)	25
Part 1	STARTED	Part 1: SM-88 920 mg	24
Part 1	STARTED	Part 2: SM-88 920 mg	0
Part 1	STARTED	Part 2: Physician's Choice	0
Part 1	Received At Least 1 Dose of Study Drug	Part 1: SM-88 460 Milligrams (mg)	25
Part 1	Received At Least 1 Dose of Study Drug	Part 1: SM-88 920 mg	23
Part 1	Received At Least 1 Dose of Study Drug	Part 2: SM-88 920 mg	0
Part 1	Received At Least 1 Dose of Study Drug	Part 2: Physician's Choice	0
Part 1	COMPLETED	Part 1: SM-88 460 Milligrams (mg)	0
Part 1	COMPLETED	Part 1: SM-88 920 mg	0

1 to 10 of 32Source ClinicalTrials.gov

See all 32 participant flow

Adverse events384

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	Anaemia	Blood and lymphatic system disorders	Part 1: SM-88 460 mg	2	25
other	Anaemia	Blood and lymphatic system disorders	Part 1: SM-88 920 mg	3	23
other	Anaemia	Blood and lymphatic system disorders	Part 2: SM-88 920 mg	3	40
other	Anaemia	Blood and lymphatic system disorders	Part 2: Physician's Choice	3	30
other	Neutropenia	Blood and lymphatic system disorders	Part 1: SM-88 460 mg	0	25
other	Neutropenia	Blood and lymphatic system disorders	Part 1: SM-88 920 mg	0	23
other	Neutropenia	Blood and lymphatic system disorders	Part 2: SM-88 920 mg	0	40
other	Neutropenia	Blood and lymphatic system disorders	Part 2: Physician's Choice	1	30
other	Abdominal pain	Gastrointestinal disorders	Part 1: SM-88 460 mg	0	25
other	Abdominal pain	Gastrointestinal disorders	Part 1: SM-88 920 mg	1	23

1 to 10 of 384Source ClinicalTrials.gov

See all 384 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Part 1: SM-88 460 mg	23	25
Total, all-cause mortality	Part 1: SM-88 920 mg	18	24
Total, all-cause mortality	Part 2: SM-88 920 mg	32	41
Total, all-cause mortality	Part 2: Physician's Choice	21	40
Total, other adverse events	Part 1: SM-88 460 mg	12	25
Total, other adverse events	Part 1: SM-88 920 mg	10	23
Total, other adverse events	Part 2: SM-88 920 mg	23	40
Total, other adverse events	Part 2: Physician's Choice	18	30
Total, serious adverse events	Part 1: SM-88 460 mg	14	25
Total, serious adverse events	Part 1: SM-88 920 mg	12	23

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35499204	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/NCT03512756

GET https://conductscience.org/api/trials/v1/NCT03512756/flow?page=2

API reference For AI assistants