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NCT03162510: SOLAR

Biweekly SOLAR, as First-line C/T in Pts With Gastric, Pancreatic and Biliary Cancers

Completed Phase 1 Last updated 7 April 2022
What this trial tests

Phase 1 trial testing Oxaliplatin in Gastric Cancer in Situ in 18 participants. Completed in 31 January 2022.

Timeline
26 June 2018
Primary endpoint
7 June 2021
31 January 2022

Quick facts

Lead sponsorNational Health Research Institutes, Taiwan
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment18
Start date26 June 2018
Primary completion7 June 2021
Estimated completion31 January 2022
Sites1 location across Taiwan

Drugs / interventions tested

Conditions studied

Sponsor

National Health Research Institutes, Taiwan

Who can join

Adults 20 to 70, any sex, with Gastric Cancer in Situ or Pancreatic Cancers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary purpose of the study is to determine the maximal tolerated dose (MTD) of Oxaliplatin in this phase I study. The secondary objectives are to determine the response rate, progression free survival, overall survival, and safety profiles. Eligible patients will receive a triplet chemotherapy consisting of nab-paclitaxel (Abraxane®) 150 mg/m2 IVD 30 min followed by Oxaliplatin 60 - 85 mg/m2 IVD 2hr at D1, plus oral S-1 35mg/m2 and Leucovorin 30mg twice daily from D1 to D7, every 14 days as a cycle till disease progression.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Case Report: Maintenance Nivolumab in Complete Responder After Multimodality Therapy in Metastatic Pancreatic Adenocarcinoma.
    Yang SH, Lee JC, Chen BB, Kuo SH, et al · · 2022 · cited 1× · PMID 35572526 · DOI 10.3389/fimmu.2022.870406
  2. A phase 1 study of biweekly nab-paclitaxel/oxaliplatin/S-1/LV for advanced upper gastrointestinal cancers: TCOG T1216 study.
    Tsai HJ, Yang SH, Hsiao CF, Kao HF, et al · · 2024 · PMID 38902994 · DOI 10.1093/oncolo/oyae109

Verify or expand the search:

Other trials of Oxaliplatin

Trials testing the same drug.

Other National Health Research Institutes, Taiwan trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03162510.

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