^
29d
Enrollment closed
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • cisplatin • 5-fluorouracil • oxaliplatin • levoleucovorin calcium
29d
Leucovorin for the Treatment of Language Impairment in Children With Autism Spectrum Disorder (clinicaltrials.gov)
P2, N=56, Active, not recruiting, Southwest Autism Research & Resource Center | Recruiting --> Active, not recruiting | N=134 --> 56 | Trial primary completion date: Jan 2025 --> Apr 2024
Enrollment closed • Enrollment change • Trial primary completion date
|
leucovorin calcium • levoleucovorin calcium
1m
NuTide:302: A Safety, Pharmacokinetic and Efficacy Study of NUC-3373 in Combination With Standard Agents Used in Colorectal Cancer Treatment (clinicaltrials.gov)
P1/2, N=107, Completed, NuCana plc | Recruiting --> Completed | N=225 --> 107 | Trial completion date: Nov 2023 --> Mar 2024 | Trial primary completion date: Nov 2023 --> Mar 2024
Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
|
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
|
BRAF V600E • BRAF V600 • KRAS wild-type • RAS wild-type
|
Avastin (bevacizumab) • Erbitux (cetuximab) • Vectibix (panitumumab) • oxaliplatin • irinotecan • fosifloxuridine nafalbenamide (NUC-3373) • levoleucovorin calcium
2ms
Enrollment change • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • cisplatin • 5-fluorouracil • oxaliplatin • Lytgobi (futibatinib) • irinotecan • levoleucovorin calcium
3ms
Efficacy and safety of neoadjuvant sintilimab in combination with FLOT chemotherapy in patients with HER2-negative locally advanced gastric or gastroesophageal junction adenocarcinoma: an investigator-initiated, single-arm, open-label, phase II study. (PubMed, Int J Surg)
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.
P2 data • Journal • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
|
HER-2 negative
|
docetaxel • 5-fluorouracil • Tyvyt (sintilimab) • oxaliplatin • leucovorin calcium • levoleucovorin calcium
4ms
CLIMB: Treatment of Colorectal Liver Metastases With Immunotherapy and Bevacizumab (clinicaltrials.gov)
P2, N=20, Completed, Asan Medical Center | Active, not recruiting --> Completed
Trial completion
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • 5-fluorouracil • oxaliplatin • levoleucovorin calcium
4ms
New P2 trial • Metastases
|
5-fluorouracil • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • levoleucovorin calcium
5ms
LAP-NET1: Study Investigating the Association of NP137 With mFOLFIRINOX in Locally Advanced Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
P1, N=52, Recruiting, University Hospital, Grenoble | Not yet recruiting --> Recruiting | Trial completion date: Nov 2024 --> Nov 2025
Enrollment open • Trial completion date • Metastases
|
5-fluorouracil • oxaliplatin • irinotecan • NP137 • levoleucovorin calcium
5ms
Trial completion date • Trial primary completion date
|
Avastin (bevacizumab) • 5-fluorouracil • Vectibix (panitumumab) • oxaliplatin • leucovorin calcium • levoleucovorin calcium
6ms
Cadonilimab Plus FOLFOXIRI and Bevacizumab as First Line Therapy for Metastatic MSS Colorectal Cancer (clinicaltrials.gov)
P2, N=20, Recruiting, Fujian Cancer Hospital | Not yet recruiting --> Recruiting | Initiation date: May 2023 --> Nov 2023
Enrollment open • Trial initiation date • Combination therapy • Metastases
|
MSI (Microsatellite instability)
|
Avastin (bevacizumab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • Kaitanni (cadonilimab) • levoleucovorin calcium
7ms
Ramucirumab plus FOLFIRI as second-line treatment for patients with RAS wild-type metastatic colorectal cancer previously treated with anti-EGFR antibody: JACCRO CC-16. (PubMed, ESMO Open)
Our study demonstrated prospectively that RAM plus FOLFIRI is an effective second-line treatment after anti-EGFR antibody-containing first-line therapy in RAS wild-type and left-sided mCRC. Furthermore, the results were similar for patients who were previously treated with triplet regimen.
Journal • Metastases
|
RAS (Rat Sarcoma Virus)
|
RAS wild-type
|
Erbitux (cetuximab) • 5-fluorouracil • Cyramza (ramucirumab) • irinotecan • leucovorin calcium • levoleucovorin calcium
7ms
Leucovorin for the Treatment of Language Impairment in Children With Autism Spectrum Disorder (clinicaltrials.gov)
P2, N=134, Recruiting, Southwest Autism Research & Resource Center | Active, not recruiting --> Recruiting | Trial completion date: Jul 2024 --> Jan 2025 | Trial primary completion date: Jul 2023 --> Jan 2025
Enrollment open • Trial completion date • Trial primary completion date
|
leucovorin calcium • levoleucovorin calcium
8ms
High vs. low-dose leucovorin in regimens with fluorouracil in colorectal cancer therapy. (PubMed, Ceska Slov Farm)
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.
Journal
|
5-fluorouracil • leucovorin calcium • levoleucovorin calcium
9ms
Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors (clinicaltrials.gov)
P2, N=26, Recruiting, Taiho Oncology, Inc. | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • cisplatin • 5-fluorouracil • oxaliplatin • Lytgobi (futibatinib) • levoleucovorin calcium
10ms
Parallel administration of nanoliposomal irinotecan and levo-leucovorin for pancreatic cancer. (PubMed, BMC Cancer)
The parallel administration of nal-IRI and Levo-LV is clinically safe and not inferior in efficacy. Moreover, parallel administration may offer convenience to patients and healthcare workers by reducing administration time.
Journal
|
5-fluorouracil • Onivyde (nanoliposomal irinotecan) • levoleucovorin calcium
10ms
New P2 trial • Combination therapy
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • cisplatin • 5-fluorouracil • oxaliplatin • Lytgobi (futibatinib) • levoleucovorin calcium
11ms
NuTide:302: A Safety, Pharmacokinetic and Efficacy Study of NUC-3373 in Combination With Standard Agents Used in Colorectal Cancer Treatment (clinicaltrials.gov)
P1/2, N=225, Recruiting, NuCana plc | Trial completion date: Jun 2023 --> Nov 2023 | Trial primary completion date: Jun 2023 --> Nov 2023
Trial completion date • Trial primary completion date • Combination therapy
|
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
|
BRAF V600E • BRAF V600 • KRAS wild-type • RAS wild-type
|
Avastin (bevacizumab) • Erbitux (cetuximab) • Vectibix (panitumumab) • oxaliplatin • irinotecan • fosifloxuridine nafalbenamide (NUC-3373) • levoleucovorin calcium
11ms
NUC-3373 in Combination With Other Agents in Patients With Advanced Solid Tumours (clinicaltrials.gov)
P1/2, N=91, Recruiting, NuCana plc | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy • Metastases
|
MSI (Microsatellite instability)
|
Keytruda (pembrolizumab) • docetaxel • fosifloxuridine nafalbenamide (NUC-3373) • levoleucovorin calcium
11ms
Levoleucovorin inhibits LOXL2 (lysyl oxidase like-2) to control breast cancer proliferation: a repurposing approach. (PubMed, J Biomol Struct Dyn)
Levoleucovorin controlled cell proliferations in MDM-MB 231 and MCF-7 cells with GI50 values of 55.91 μM and 79.20 μM respectively. Further, a dose dependent inhibition of cancer cell migration was noted along with apoptosis induction in these cells with levoleucovorin treatment.Communicated by Ramaswamy H. Sarma.
Journal
|
levoleucovorin calcium
12ms
Posterior reversible encephalopathy syndrome triggered by FLOT (5-fluorouracil, oxaliplatin, docetaxel, and calcium levofolinate) chemotherapy and thrombocytopenia (docetaxel and cisplatin) chemotherapy. (PubMed, J Oncol Pharm Pract)
Posterior reversible encephalopathy syndrome is a clinical and imaging syndrome characterized by endothelial dysfunction, blood-brain barrier disruption, and vasogenic edema. This is the first report that posterior reversible encephalopathy syndrome is caused by a thrombocytopenia regimen, and our case highlights the pathogenic role of a thrombocytopenia regimen in posterior reversible encephalopathy syndrome. However, the association between the thrombocytopenia regimen and previous fluorouracil, leucovorin, oxaliplatin, and docetaxel regimens needs further study.
Journal
|
cisplatin • docetaxel • 5-fluorouracil • oxaliplatin • leucovorin calcium • levoleucovorin calcium
12ms
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, Lancet)
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.
P3 data • Journal • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
|
HER-2 negative • CLDN18.2 positive • EGFR positive
|
5-fluorouracil • oxaliplatin • leucovorin calcium • Vyloy (zolbetuximab) • levoleucovorin calcium
1year
A Study of NUC-3373 in Combination With Other Agents in Patients With Colorectal Cancer (clinicaltrials.gov)
P2, N=171, Recruiting, NuCana plc | Initiation date: Jan 2023 --> Apr 2023
Trial initiation date
|
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
|
KRAS wild-type • RAS wild-type • UGT1A1*1*1
|
Avastin (bevacizumab) • 5-fluorouracil • irinotecan • leucovorin calcium • fosifloxuridine nafalbenamide (NUC-3373) • levoleucovorin calcium
1year
New P2 trial
|
MSI (Microsatellite instability)
|
Avastin (bevacizumab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • Kaitanni (cadonilimab) • levoleucovorin calcium
1year
Enrollment closed • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • 5-fluorouracil • Lenvima (lenvatinib) • capecitabine • oxaliplatin • levoleucovorin calcium
1year
FOLFOX regimen after failure of fluorouracil and leucovorin plus nanoliposomal-irinotecan therapy for advanced pancreatic cancer: a retrospective observational study. (PubMed, BMC Cancer)
FOLFOX as a subsequent treatment after failure of second-line treatment with 5FU/LV + nal-IRI is tolerable, although its efficacy is limited, particularly in patients with high CRP levels.
Observational data • Retrospective data • Journal • Metastases
|
CRP (C-reactive protein)
|
gemcitabine • 5-fluorouracil • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • levoleucovorin calcium
over1year
NuTide:302: A Safety, Pharmacokinetic and Efficacy Study of NUC-3373 in Combination With Standard Agents Used in Colorectal Cancer Treatment (clinicaltrials.gov)
P1/2, N=225, Recruiting, NuCana plc | Trial completion date: Dec 2022 --> Jun 2023 | Trial primary completion date: Dec 2022 --> Jun 2023
Trial completion date • Trial primary completion date • Combination therapy
|
BRAF (B-raf proto-oncogene)
|
Avastin (bevacizumab) • Erbitux (cetuximab) • Vectibix (panitumumab) • oxaliplatin • irinotecan • fosifloxuridine nafalbenamide (NUC-3373) • levoleucovorin calcium
over1year
New P2 trial • Combination therapy • Metastases
|
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
|
KRAS wild-type • RAS wild-type • UGT1A1*1*1
|
Avastin (bevacizumab) • 5-fluorouracil • irinotecan • leucovorin calcium • fosifloxuridine nafalbenamide (NUC-3373) • levoleucovorin calcium
over1year
KEYNOTE 975: Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975) (clinicaltrials.gov)
P3, N=700, Recruiting, Merck Sharp & Dohme LLC | Trial completion date: Feb 2026 --> Feb 2027 | Trial primary completion date: Feb 2026 --> Feb 2027
Trial completion date • Trial primary completion date
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • cisplatin • 5-fluorouracil • oxaliplatin • levoleucovorin calcium
over1year
Trial completion date • Trial primary completion date • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • 5-fluorouracil • Lenvima (lenvatinib) • capecitabine • oxaliplatin • levoleucovorin calcium
over1year
A post-marketing safety study of ramucirumab with FOLFIRI in patients with metastatic colorectal cancer. (PubMed, J Gastrointest Oncol)
Ramucirumab [human vascular endothelial growth factor (VEGF) receptor-2 monoclonal antibody] + levofolinate, fluorouracil, and irinotecan (FOLFIRI) was approved for the treatment of metastatic colorectal cancer (CRC) in Japan based on the results from the phase 3 RAISE trial (NCT01183780)...Approximately 83.7% (n=303) and 25.4% (n=92) of patients had medication history of bevacizumab and anti-epidermal growth factor receptor (EGFR) antibodies, respectively...Although the current observational study enrolled patients with various medication history, the regimen of ramucirumab + FOLFIRI was manageable under clinical practice. No new safety concerns beyond the findings observed in previous clinical trials were reported.
P4 data • Journal
|
EGFR (Epidermal growth factor receptor)
|
Avastin (bevacizumab) • 5-fluorouracil • Cyramza (ramucirumab) • irinotecan • leucovorin calcium • levoleucovorin calcium
almost2years
Dynamic changes in RAS gene status in circulating tumour DNA: a phase II trial of first-line FOLFOXIRI plus bevacizumab for RAS-mutant metastatic colorectal cancer (JACCRO CC-11). (PubMed, ESMO Open)
Our biomarker study demonstrated no RAS mutations in ctDNA at disease progression in 62% of patients with RAS-mutant mCRC. Both OS and post-progression survival were better in patients with clearance of RAS mutations in ctDNA after triplet-based chemotherapy.
P2 data • Clinical Trial,Phase II • Journal • Circulating tumor DNA
|
KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • RAS (Rat Sarcoma Virus)
|
RAS mutation
|
Avastin (bevacizumab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • levoleucovorin calcium
2years
Enrollment open • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2)
|
RAS wild-type
|
Avastin (bevacizumab) • Herceptin (trastuzumab) • Erbitux (cetuximab) • 5-fluorouracil • oxaliplatin • Tukysa (tucatinib) • leucovorin calcium • levoleucovorin calcium
2years
New P3 trial • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2)
|
RAS wild-type
|
Avastin (bevacizumab) • Herceptin (trastuzumab) • Erbitux (cetuximab) • 5-fluorouracil • Tukysa (tucatinib) • leucovorin calcium • levoleucovorin calcium
2years
PARADIGM: Panitumumab and RAS, Diagnostically-useful Gene Mutation for mCRC (clinicaltrials.gov)
P3, N=823, Completed, Takeda | Active, not recruiting --> Completed
Trial completion • Combination therapy
|
KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog)
|
KRAS wild-type • RAS wild-type • NRAS wild-type
|
Avastin (bevacizumab) • 5-fluorouracil • Vectibix (panitumumab) • oxaliplatin • levoleucovorin calcium
over2years
PARADIGM: Panitumumab and RAS, Diagnostically-useful Gene Mutation for mCRC (clinicaltrials.gov)
P3, N=823, Active, not recruiting, Takeda | Trial completion date: Aug 2021 --> Jan 2022 | Trial primary completion date: Aug 2021 --> Jan 2022
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog)
|
KRAS wild-type • RAS wild-type • NRAS wild-type
|
Avastin (bevacizumab) • 5-fluorouracil • Vectibix (panitumumab) • oxaliplatin • levoleucovorin calcium
over2years
LIBImAb: Study in mCRC Patients RAS/BRAF wt Tissue and RAS Mutated LIquid BIopsy to Compare FOLFIRI Plus CetuxiMAb or BevacizumaB (clinicaltrials.gov)
P3, N=280, Recruiting, Azienda Unità Sanitaria Locale Reggio Emilia | Not yet recruiting --> Recruiting
Clinical • Enrollment open • Liquid biopsy
|
BRAF (B-raf proto-oncogene)
|
Avastin (bevacizumab) • Erbitux (cetuximab) • 5-fluorouracil • irinotecan • leucovorin calcium • levoleucovorin calcium
over2years
Clinical • Enrollment open
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • cisplatin • 5-fluorouracil • Lenvima (lenvatinib) • oxaliplatin • levoleucovorin calcium
almost3years
Clinical • New P3 trial
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • cisplatin • 5-fluorouracil • Lenvima (lenvatinib) • oxaliplatin • levoleucovorin calcium
3years
Clinical • New P3 trial • Liquid biopsy
|
BRAF (B-raf proto-oncogene)
|
Avastin (bevacizumab) • Erbitux (cetuximab) • 5-fluorouracil • irinotecan • leucovorin calcium • levoleucovorin calcium
3years
Folinic acid in colorectal cancer: esquire or fellow knight? Real-world results from a mono institutional, retrospective study. (PubMed, Oncotarget)
5-Fluorouracil (5FU) seems to act differently depending on administration elastomer-mediated continuous infusion better inhibits Thymidylate Synthase (TS), an enzyme playing a pivotal role in DNA synthetic pathway. The simultaneous combination of 5FU and folinate salt synergistically strengthens fluorouracil cytotoxic effect. In our experience, levofolinate and 5FU together in continuous infusion prolong progression free survival of patients suffering from mCRC, moreover decreasing death risk and showing a clear clinical benefit for patients, irrespective of RAS mutational status, primitive tumor side and metastases surgery.
Retrospective data • Journal • Real-World Evidence
|
TYMS (Thymidylate Synthetase)
|
5-fluorouracil • leucovorin calcium • levoleucovorin calcium
over3years
Clinical • New P3 trial
|
HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
|
HER-2 negative
|
Keytruda (pembrolizumab) • Lenvima (lenvatinib) • capecitabine • oxaliplatin • levoleucovorin calcium
almost4years
PARADIGM: Panitumumab and RAS, Diagnostically-useful Gene Mutation for mCRC (clinicaltrials.gov)
P3, N=823, Active, not recruiting, Takeda | Trial completion date: Jun 2020 --> Aug 2021 | Trial primary completion date: Jun 2020 --> Aug 2021
Clinical • Trial completion date • Trial primary completion date • Combination therapy
|
KRAS (KRAS proto-oncogene GTPase) • NRAS (Neuroblastoma RAS viral oncogene homolog)
|
Avastin (bevacizumab) • 5-fluorouracil • Vectibix (panitumumab) • oxaliplatin • levoleucovorin calcium