- |||||||||| Onivyde (nanoliposomal irinotecan) / Servier, Ipsen
Enrollment closed, Metastases: Phase 2 Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Levoleucovorin in Japanese Participants Not Previously Treated for Metastatic Adenocarcinoma of the Pancreas (clinicaltrials.gov) - Aug 9, 2024 P2, N=41, Active, not recruiting, Not yet recruiting --> Recruiting Not yet recruiting --> Active, not recruiting
- |||||||||| Opdivo (nivolumab) / BMS, magrolimab (ONO-7913) / Ono Pharma
New P1 trial, Combination therapy, Metastases: An Open-label, Uncontrolled Study of ONO-7913 and ONO-4538 in Combination With Modified FOLFIRINOX Therapy, the Standard of Care, as First-line Treatment in Patients With Metastatic Pancreatic Cancer (clinicaltrials.gov) - Aug 1, 2024 P1, N=32, Active, not recruiting,
- |||||||||| fosifloxuridine nafalbenamide (NUC-3373) / NuCana
Trial completion, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy: NuTide:302: A Safety, Pharmacokinetic and Efficacy Study of NUC-3373 in Combination With Standard Agents Used in Colorectal Cancer Treatment (clinicaltrials.gov) - Apr 3, 2024 P1/2, N=107, Completed, The study demonstrated an encouraging efficacy and manageable safety profile of neoadjuvant sintilimab plus FLOT in HER2-negative locally advanced G/GEJ cancer, which suggested a potential therapeutic option for this population. Recruiting --> Completed | N=225 --> 107 | Trial completion date: Nov 2023 --> Mar 2024 | Trial primary completion date: Nov 2023 --> Mar 2024
- |||||||||| fosifloxuridine nafalbenamide (NUC-3373) / NuCana
Enrollment closed, Combination therapy, Metastases: A Study of NUC-3373 in Combination With Other Agents in Patients With Colorectal Cancer (clinicaltrials.gov) - Apr 3, 2024 P2, N=182, Active, not recruiting, Recruiting --> Completed | N=225 --> 107 | Trial completion date: Nov 2023 --> Mar 2024 | Trial primary completion date: Nov 2023 --> Mar 2024 Recruiting --> Active, not recruiting
- |||||||||| Teysuno (gimeracil/oteracil/tegafur) / Nordic Group, Otsuka
Randomized phase II study comparing neoadjuvant FLOT versus DOS for patients with type 4 or large type 3 gastric cancer (JCOG2204). (Poster Bd # N3) - Dec 6, 2023 - Abstract #ASCOGI2024ASCO_GI_121; JCOG2204 is a multi-center, randomized phase II trial comparing neoadjuvant chemotherapy with FLOT (5-fluorouracil/levofolinate/oxaliplatin/docetaxel) versus DOS for resectable type 4 and large type 3 GC...Enrollment in JCOG2204 begun on 14th July, 2023 and clinical trial information is available in Japan Registry of Clinical Trials (jRCTs031230231). Clinical trial information: jRCTs031230231.
- |||||||||| leucovorin calcium / Generic mfg.
Enrollment open, Trial completion date, Trial primary completion date: Leucovorin for the Treatment of Language Impairment in Children With Autism Spectrum Disorder (clinicaltrials.gov) - Oct 25, 2023 P2, N=134, Recruiting, Furthermore, the results were similar for patients who were previously treated with triplet regimen. Active, not recruiting --> Recruiting | Trial completion date: Jul 2024 --> Jan 2025 | Trial primary completion date: Jul 2023 --> Jan 2025
- |||||||||| leucovorin calcium / Generic mfg.
Trial completion date, Trial primary completion date: Treatment of Social and Language Deficits With Leucovorin for Young Children With Autism (clinicaltrials.gov) - Oct 25, 2023 P2, N=80, Recruiting, Active, not recruiting --> Recruiting | Trial completion date: Jul 2024 --> Jan 2025 | Trial primary completion date: Jul 2023 --> Jan 2025 Trial completion date: Dec 2023 --> Jan 2025 | Trial primary completion date: Dec 2023 --> Jan 2025
- |||||||||| Lynparza (olaparib) / Merck (MSD), AstraZeneca
Trial completion, Trial completion date, Combination therapy, Metastases: Efficacy and Safety of Olaparib (MK-7339) With or Without Bevacizumab Compared to Bevacizumab With a Fluoropyrimidine in Unresectable or Metastatic Colorectal Cancer (CRC) (MK-7339-003/LYNK-003) (clinicaltrials.gov) - Oct 19, 2023 P3, N=335, Completed, However, the association between the thrombocytopenia regimen and previous fluorouracil, leucovorin, oxaliplatin, and docetaxel regimens needs further study. Active, not recruiting --> Completed | Trial completion date: Jul 2024 --> Oct 2023
- |||||||||| 5-fluorouracil / Generic mfg., leucovorin calcium / Generic mfg.
Journal: High vs. low-dose leucovorin in regimens with fluorouracil in colorectal cancer therapy. (Pubmed Central) - Aug 30, 2023 In 17 cases, the departments for the preparation of cytostatics in the Czech Republic had to accept restrictions on administering the full dose of leucovorin. These restrictions consisted of reducing the dose of the injectable form of leucovorin, changing the chemotherapy regimen, administering the oral form of calcium folinate, forcing a therapeutic break, or a combination of these approaches.
- |||||||||| Lytgobi (futibatinib) / Otsuka
Enrollment open, Combination therapy: Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors (clinicaltrials.gov) - Aug 8, 2023 P2, N=26, Recruiting, These restrictions consisted of reducing the dose of the injectable form of leucovorin, changing the chemotherapy regimen, administering the oral form of calcium folinate, forcing a therapeutic break, or a combination of these approaches. Not yet recruiting --> Recruiting
- |||||||||| zolbetuximab (IMAB362) / Astellas
P3 data, Journal, Metastases: Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial. (Pubmed Central) - May 22, 2023 P3 Targeting CLDN18.2 with zolbetuximab significantly prolonged progression-free survival and overall survival when combined with mFOLFOX6 versus placebo plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma. Zolbetuximab plus mFOLFOX6 might represent a new first-line treatment in these patients.
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