Evidence map›Paper›PMID 35499204›Full record

Trial reportCancer medicine2022

A randomized phase II study of SM-88 plus methoxsalen, phenytoin, and sirolimus in patients with metastatic pancreatic cancer treated in the second line and beyond.

Marcus S Noel, Semmie Kim, Marion L Hartley, Steve Wong, Vincent J Picozzi, Harry Staszewski, Dae Won Kim, Jan M Van Tornout, Philip Agop Philip, Vincent Chung and 2 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03512756 (A Randomized Phase 2/3 Multi-Center Study of SM-88 in Subjects With Pancreatic Cancer Whose Disease Has Progressed or Recurred), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.6field-weighted citation impact, top 31% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03512756 phase2 / phase3terminatednot on this map

A Randomized Phase 2/3 Multi-Center Study of SM-88 in Subjects With Pancreatic Cancer Whose Disease Has Progressed or Recurred

TypeinterventionalSponsorTyme, IncRan2018 to 2021Enrolled130ConditionsPancreatic CancerArmsSM-88 used with MPS (methoxsalen, phenytoin, sirolimus), Capecitabine, Gemcitabine, and 5-FU
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 11 institutions in 1 country.

Marcus S NoelGeorgetown Lombardi Comprehensive Cancer Center, Washington, District of Columbia, USA.ORCID 0000-0002-3658-6950
Semmie KimTYME Technologies Inc., Bedminster, New Jersey, USA.
Marion L HartleyThe Ruesch Center for the Cure of Gastrointestinal Cancers, Washington, District of Columbia, USA.ORCID 0000-0001-5516-297X
Steve WongSarcoma Oncology Research Center, Santa Monica, California, USA.
Vincent J PicozziVirginia Mason Hospital and Medical Center, Seattle, Washington, USA.
Harry StaszewskiMather Hospital, Port Jefferson, New York, USA.
Dae Won KimThe University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Jan M Van TornoutTYME Technologies Inc., Bedminster, New Jersey, USA.
Philip Agop PhilipKarmanos Cancer Center, Wayne State University, Michigan, Detroit, USA.
Vincent ChungCity of Hope, Duarte, California, USA.
Allyson J OceanWeill Cornell Medicine, New York-Presbyterian Hospital, New York, New York, USA.
Andrea Wang-GillamWashington University School of Medicine in St. Louis, St. Louis, Missouri, USA.
QRx Pharma (United States) · USCity of Hope · USGeorgetown University · USJohn T. Mather Memorial Hospital · USMichigan School of Professional Psychology · USNewYork–Presbyterian Hospital · USSarcoma Oncology Center · USThe University of Texas MD Anderson Cancer Center · USVirginia Mason Medical Center · USWashington Center · USWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis trial explores SM-88 used with methoxsalen, phenytoin, and sirolimus (MPS) in pretreated metastatic pancreatic ductal adenocarcinoma (mPDAC)

methodsForty-nine patients were randomized to daily 460 or 920 mg oral SM-88 with MPS (SM-88 Regimen). The primary endpoint was objective response rate (RECIST 1.1).

resultsThirty-seven patients completed ≥ one cycle of SM-88 Regimen (response evaluable population). Disease control rate (DCR), overall survival (OS), and progression-free survival (PFS) did not differ significantly between dose levels. Stable disease was achieved in 9/37 patients (DCR, 24.3%); there were no complete or partial responses. Quality-of-life (QOL) was maintained and trended in favor of 920 mg. SM-88 Regimen was well tolerated; a single patient (1/49) had related grade 3 and 4 adverse events, which later resolved. In the intention-to-treat population of 49 patients, the median overall survival (mOS) was 3.4 months (95% CI: 2.7-4.9 months). Those treated in the second line had an mOS of 8.1 months and a median PFS of 3.8 months. Survival was higher for patients with stable versus progressive disease (any line; mOS: 10.6 months vs. 3.9 months; p = 0.01).

conclusionsSM-88 Regimen has a favorable safety profile with encouraging QOL effects, disease control, and survival trends. This regimen should be explored in the second-line treatment of patients with mPDAC. CLINICALTRIALS: gov Identifier: NCT03512756.

Indexed as

AdenocarcinomaPancreatic NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsHumansMethoxsalenPhenytoinQuality of LifeSirolimusMethoxsalenPhenytoinSirolimus

Identifiers

PMID35499204
PMCPMC9678093
OpenAlexW4225291132

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.