Trial reportInvestigational new drugs2005
Phase I trial of orally administered CEP-701, a novel neurotrophin receptor-linked tyrosine kinase inhibitor.
Trial report in Investigational new drugs, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
43 citing papers in PubMed, 1 synthesis or guideline pooled it, 95 citations in OpenAlex.
- Efficacy and safety of FLT3 inhibitors in monotherapy of hematological and solid malignancies: a systemic analysis of clinical trials.Frontiers in pharmacology · 2024Pooled it
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- Anoikis resistance in Cancer: Mechanisms, therapeutic strategies, potential targets, and models for enhanced understanding.Cancer letters · 2025Review
- Deciphering the Biology of Circulating Tumor Cells through Single-Cell RNA Sequencing: Implications for Precision Medicine in Cancer.International journal of molecular sciences · 2023Review
- Development and Validation of an Individualized Metabolism-Related Prognostic Model for Adult Acute Myeloid Leukemia Patients.Frontiers in oncology · 2022Article
- Glial-derived neurotrophic factor in human airway smooth muscle.Journal of cellular physiology · 2021Article
- The Ups and Downs of STAT Inhibition in Acute Myeloid Leukemia.Biomedicines · 2021Review
- AR-dependent phosphorylation and phospho-proteome targets in prostate cancer.Endocrine-related cancer · 2020Review
- Nerves in the Tumor Microenvironment: Origin and Effects.Frontiers in cell and developmental biology · 2020Review
- Article
- FLT3 inhibitors in acute myeloid leukemia.Journal of hematology & oncology · 2018Review
- Review of Chromatographic Bioanalytical Assays for the Quantitative Determination of Marine-Derived Drugs for Cancer Treatment.Marine drugs · 2018Review
- Tropomyosin-related kinase B/brain derived-neurotrophic factor signaling pathway as a potential therapeutic target for colorectal cancer.World journal of gastroenterology · 2016Review
- NGF-induced TrkA/CD44 association is involved in tumor aggressiveness and resistance to lestaurtinib.Oncotarget · 2015Article
- Integrated genomic study of quadruple-WT GIST (KIT/PDGFRA/SDH/RAS pathway wild-type GIST).BMC cancer · 2014Article
- Quizartinib for the treatment of FLT3/ITD acute myeloid leukemia.Future oncology (London, England) · 2014Review
- Perturbation of the mutated EGFR interactome identifies vulnerabilities and resistance mechanisms.Molecular systems biology · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeA phase I clinical trial in patients with advanced carcinomas was conducted using the orally available neurotrophin receptor-linked tyrosine kinase receptor inhibitor, CEP-701. The objectives were to determine the maximum tolerated dose (MTD), dose-limiting toxicities, and pharmacokinetic profile of this orally administered agent. PATIENTS AND
methodsA total of 30 patients were accrued to receive escalating BID doses of CEP-701 in cycles lasting 28 days. Between 3 and 6 patients were enrolled at each dose level. Once the MTD was determined, nine de novo patients were recruited to receive that level of drug. Pharmacokinetic studies were performed after the first dose, with additional sampling to assess intraindividual variability.
resultsThe dosages ranged from 5 mg BID to 160 mg BID. While the criteria for MTD were not met at the dose levels administered, DLTs were observed at 80 and 120 mg BID. Treatment related adverse events, especially of the gastrointestinal system, made CEP-701 poorly tolerated at dosages above 40 mg BID. While CEP-701 did not produce an objective tumor response in any patient, 7 of the 30 patients received treatment for 3 months or more, including 3 who were on study with stable disease for more than 6 months. Orally administered CEP-701 was rapidly absorbed, with a mean t(max) between 1 and 3 hours. At higher dose levels, serum drug levels showed greater than dose-proportional increases by Day 28 versus Day 1.
conclusionCEP-701 40 mg BID was well tolerated by patients with advanced malignancy and is the recommended dose level for planned phase II trials. Further study is necessary to determine the clinical efficacy of this novel new chemotherapeutic agent.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.