- |||||||||| Vectibix (panitumumab) / Amgen
Biomarker, Enrollment closed, Trial completion date, Trial primary completion date, Metastases: PARADIGM biomarker: An Exploratory Study of Treatment Sensitivity and Prognostic Factors in a Efficacy and Safety Study of mFOLFOX6 + Bevacizumab Versus mFOLFOX6 + Panitumumab Therapy in Patients With Chemotherapy-na (clinicaltrials.gov) - Dec 2, 2022 P3, N=757, Active, not recruiting, Trial completion date: Feb 2026 --> Feb 2027 | Trial primary completion date: Feb 2026 --> Feb 2027 Completed --> Active, not recruiting | Trial completion date: Jan 2022 --> Apr 2023 | Trial primary completion date: Jan 2022 --> Apr 2023
- |||||||||| Tevimbra (tislelizumab) / BeiGene, Novartis
Trial completion date, Trial initiation date, Trial primary completion date: Phase I Study of the Combination of Irinotecan and POF (POFI) and Tislelizumab (clinicaltrials.gov) - Nov 16, 2022 P1, N=20, Not yet recruiting, Completed --> Active, not recruiting | Trial completion date: Jan 2022 --> Apr 2023 | Trial primary completion date: Jan 2022 --> Apr 2023 Trial completion date: Mar 2024 --> Dec 2024 | Initiation date: Apr 2022 --> Dec 2022 | Trial primary completion date: Mar 2023 --> Dec 2023
- |||||||||| leucovorin calcium / Generic mfg.
Enrollment closed, Trial completion date, Trial primary completion date: Treatment of Social and Language Deficits With Leucovorin for Young Children With Autism (clinicaltrials.gov) - Sep 28, 2022 P2, N=80, Active, not recruiting, Recruiting --> Suspended Recruiting --> Active, not recruiting | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
- |||||||||| Cyramza (ramucirumab) / Eli Lilly
P4 data, Journal: A post-marketing safety study of ramucirumab with FOLFIRI in patients with metastatic colorectal cancer. (Pubmed Central) - Sep 14, 2022 P3 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.
- |||||||||| AiTan (rivoceranib) / HLB Bio Group, AiRuiKa (camrelizumab) / Jiangsu Hengrui Pharma
Camrelizumab plus apatinib combined with POF in patients with untreated advanced gastric cancer (UAGC): A single-center, open-label, single-arm, phase II trial (SYLT-017) (Poster Area, Hall 4) - Jul 28, 2022 - Abstract #ESMO2022ESMO_3275; P2 The PD-1 inhibitor nivolumab provided superior OS, along with PFS benefit, in combination with chemotherapy in UAGC in the CheckMate-649 study...Patients received camrelizumab 200 mg every 2 weeks and apatinib 750 mg once per day in combination with the POF regimen: intravenous paclitaxel 135 mg/m 2 , oxaliplatin 85 mg/m 2 , levoleucovorin 200 mg/m 2 followed by 5-FU 2400 mg/m 2 as a 46-hour continuous infusion, every 14 days for 12 cycles...The most common potential immune-related AEs included grade 1-2 hypothyroidism (25.0%). Conclusions Camrelizumab plus apatinib combined with POF as first-line treatment has shown promising efficacy and acceptable safety, and may be a favorable option for patients with UAGC.
- |||||||||| Lynparza (olaparib) / Merck (MSD), AstraZeneca
Enrollment closed, 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) - Jul 28, 2022 P3, N=525, Active, not recruiting, Conclusions Camrelizumab plus apatinib combined with POF as first-line treatment has shown promising efficacy and acceptable safety, and may be a favorable option for patients with UAGC. Recruiting --> Active, not recruiting
- |||||||||| levoleucovorin calcium / Generic mfg., leucovorin calcium / Generic mfg.
Preclinical, Journal: Absorption and Tissue Distribution of Folate Forms in Rats: Indications for Specific Folate Form Supplementation during Pregnancy. (Pubmed Central) - Jul 1, 2022 However, only 50% of the leucovorin is metabolically active whereas levofolinate is fully active and generates higher tetrahydrofolate (THF). Because levofolinate can readily incorporate into the folate cycle without needing methylenetetrahydrofolate reductase (MTHFR) and methionine synthase (MS) in the first pass and is relatively stable, it should be the folate form of choice during pregnancy, other disorders where large daily doses of folate are needed, and food fortification.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD)
First-line lenvatinib plus pembrolizumab plus chemotherapy in esophageal squamous cell carcinoma: LEAP-014 trial in progress. (Available On Demand; 149a) - Apr 28, 2022 - Abstract #ASCO2022ASCO_2003; P3 In part 2 (main study), approximately 850 patients will be randomly assigned 1:1 to induction with pembrolizumab plus lenvatinib plus chemotherapy (FP or mFOLFOX6 [Q2W for 6 cycles {IV oxaliplatin 85 mg/m2 plus bolus IV 5-FU 400 mg/m2 plus continuous IV 5-FU 2400 mg/m2 plus IV leucovorin 400 mg/m2 or IV levoleucovorin 200 mg/m2}]) followed by consolidation with pembrolizumab plus lenvatinib (arm 1) or pembrolizumab plus chemotherapy (FP or mFOLFOX6; arm 2)...In part 2, the dual primary end points are overall survival and progression-free survival (per RECIST v1.1 assessed by blinded independent central review [BICR]); secondary end points include objective response rate and duration of response (per RECIST v1.1 assessed by BICR) and safety and tolerability. Enrollment in this trial is ongoing.
- |||||||||| Vectibix (panitumumab) / Amgen
Trial completion date, Trial primary completion date, Combination therapy, Metastases: PARADIGM: Panitumumab and RAS, Diagnostically-useful Gene Mutation for mCRC (clinicaltrials.gov) - Oct 13, 2021 P3, N=823, Active, not recruiting, This phase II study could not demonstrate any reduction in the incidence of FN, nevertheless some patients experience benefits for efficacy by maintaining dose intensity using prophylactic pegfilgrastim. Trial completion date: Aug 2021 --> Jan 2022 | Trial primary completion date: Aug 2021 --> Jan 2022
- |||||||||| Avastin (bevacizumab) / Roche
Enrollment closed, Trial completion date, Trial primary completion date, IO biomarker: CLIMB: Treatment of Colorectal Liver Metastases With Immunotherapy and Bevacizumab (clinicaltrials.gov) - Jul 21, 2021 P2, N=20, Active, not recruiting, Phase classification: P1 --> P1/2 | N=118 --> 225 | Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022 Recruiting --> Active, not recruiting | Trial completion date: Sep 2022 --> Dec 2023 | Trial primary completion date: Jul 2021 --> Dec 2021
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