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DRUG:

Velmarto (eratrectinib)

i
Other names: VC004, VC 004, VC-004
Associations
Company:
Jiangsu Vcare Pharma
Drug class:
pan-TRK inhibitor
Associations
5d
Safety, efficacy, and pharmacokinetics of eratrectinib (VC004) in solid tumors with NTRK fusions: phase 1 results from a phase 1/2 study. (PubMed, Exp Hematol Oncol)
Eratrectinib demonstrated manageable safety profile and promising efficacy in patients with NTRK fusion positive solid tumors, representing a new treatment option for this patient population. Further studies to confirm the efficacy and safety of eratrectinib are ongoing. Trial registration NCT04614740 (ClinicalTrials.gov).
P1/2 data • PK/PD data • Journal
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NTRK (Neurotrophic receptor tyrosine kinase)
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NTRK positive • NTRK fusion
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Velmarto (eratrectinib)
over1year
Phase III Clinical Study of VC004 in Patients With Localized Advanced/ Metastatic Solid Tumors (clinicaltrials.gov)
P3, N=54, Recruiting, Jiangsu vcare pharmaceutical technology co., LTD | Not yet recruiting --> Recruiting | Initiation date: Nov 2024 --> Mar 2025
Enrollment open • Trial initiation date
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Velmarto (eratrectinib)
over1year
A Clinical Trial to Evaluate the Effects of Itraconazole or Rifampicin on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects (clinicaltrials.gov)
P1, N=56, Completed, Jiangsu vcare pharmaceutical technology co., LTD | Not yet recruiting --> Completed
Trial completion
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itraconazole • Velmarto (eratrectinib) • rifampicin
over1year
Phase III Clinical Study of VC004 in Patients With Localized Advanced/ Metastatic Solid Tumors (clinicaltrials.gov)
P3, N=54, Not yet recruiting, Jiangsu vcare pharmaceutical technology co., LTD
New P3 trial
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Velmarto (eratrectinib)
almost2years
New P1 trial
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itraconazole • Velmarto (eratrectinib) • rifampicin
almost2years
Food Effect and Relative Bioavailability Study of VC004 Capsules in Healthy Adult Subjects (clinicaltrials.gov)
P1, N=84, Completed, Jiangsu vcare pharmaceutical technology co., LTD | Not yet recruiting --> Completed | Trial completion date: Dec 2024 --> Aug 2024 | Trial primary completion date: Dec 2024 --> Aug 2024
Trial completion • Trial completion date • Trial primary completion date
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Velmarto (eratrectinib)
almost2years
Food Effect and Relative Bioavailability Study of VC004 Capsules in Healthy Adult Subjects (clinicaltrials.gov)
P1, N=84, Not yet recruiting, Jiangsu vcare pharmaceutical technology co., LTD
New P1 trial
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Velmarto (eratrectinib)
over2years
ETV6::NTRK3 gene fusion in a patient with metastatic lung atypical carcinoid successfully treated with repotrectinib: A case report. (PubMed, Lung Cancer)
To the best of our knowledge, we reported the first case demonstrating anti-tumor activity of repotrectinib in a patient with AC carring an ETV6-NTRK3 gene fusion, indicating that repotrectinib may be an efficient therapeutic option for tumors with NTRK gene rearrangements.
Clinical • Observational data • Retrospective data • Review • Clinical Trial,Phase I • Clinical Trial,Phase II • Journal • Metastases
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NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • ETV6 (ETS Variant Transcription Factor 6) • NTRK (Neurotrophic receptor tyrosine kinase)
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NTRK1 fusion • NTRK3 fusion • NTRK2 fusion • ETV6-NTRK3 fusion
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everolimus • Augtyro (repotrectinib) • Velmarto (eratrectinib)
over2years
Food Effect on the Pharmacokinetics of VC004, a Tropomyosin Receptor Kinase Inhibitor: A Randomized Crossover Trial in Healthy Chinese Subjects. (PubMed, Clin Drug Investig)
The intake of high calorie food decreased the absorption rate and increased the T of VC004, while the AUC values were similar in both groups. No serious adverse event was reported. In conclusion, food does not alter the pharmacokinetics and safety profile of VC004 in a clinically meaningful manner.
PK/PD data • Journal
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NTRK (Neurotrophic receptor tyrosine kinase)
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NTRK positive • NTRK fusion
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Velmarto (eratrectinib)