Topics

INCB18424 in Treating Young Patients With Relapsed or Refractory Solid Tumor, Leukemia, or Myeloproliferative Disease

2014-08-27 03:12:10 | BioPortfolio

Summary

RATIONALE: INCB18424 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I clinical trial is studying the side effects and best dose of INCB18424 in treating young patients with relapsed or refractory solid tumor, leukemia, or myeloproliferative disease.

Description

OBJECTIVES:

Primary

- To estimate the maximum-tolerated dose and/or recommended phase II dose of oral JAK inhibitor INCB18424 administered continuously, twice daily to pediatric patients with relapsed or refractory solid tumors.

- To define and describe the toxicities of this treatment administered on this schedule in pediatric patients with relapsed or refractory solid tumors, leukemias, or myeloproliferative neoplasms (MPNs).

- To characterize the pharmacokinetics of this treatment in pediatric patients with relapsed or refractory solid tumors, leukemias, or MPNs.

Secondary

- To preliminarily define the antitumor activity of this treatment within the confines of a phase I study.

- To assess the biologic activity of oral JAK inhibitor INCB18424 upon JAK-STAT signaling in pediatric patients with relapsed leukemia or MPNs.

- To assess the biologic activity of oral JAK inhibitor INCB18424 upon phosphosignaling and mutation burden in pediatric patients whose leukemias or MPNs have known CRLF2 and/or JAK mutations.

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive oral JAK inhibitor INCB18424 twice daily on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Patients with relapsed or refractory leukemia may receive intrathecal chemotherapy in course 2 and subsequent courses at the discretion of the treating physician.

Plasma, bone marrow, and blood samples may be collected at baseline, during course 1, and before subsequent courses for pharmacokinetic analysis and correlative biology studies.

After completion of study treatment, patients are followed up for 30 days.

Study Design

Primary Purpose: Treatment

Conditions

Chronic Myeloproliferative Disorders

Intervention

oral JAK inhibitor INCB18424, laboratory biomarker analysis, pharmacological study

Status

Not yet recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:10-0400

Clinical Trials [3973 Associated Clinical Trials listed on BioPortfolio]

MDM2 Inhibitor AMG-232 in Treating Patients With Recurrent or Newly Diagnosed Glioblastoma

This phase 0/I trial studies the side effects and best dose of MDM2 inhibitor AMG-232 in treating patients with glioblastoma that is newly diagnosed or has come back. MDM2 inhibitor AMG-23...

HIF-2 Alpha Inhibitor PT2385 in Treating Patients With Recurrent Glioblastoma

This phase II trial studies how well HIF-2 alpha inhibitor PT2385 works in treating patients with recurrent glioblastoma. HIF-2 alpha inhibitor PT2385 may stop the growth of tumor cells by...

Akt Inhibitor MK2206 in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

This phase II trial is studying how well Akt inhibitor MK2206 works in treating patients with relapsed or refractory diffuse large B-cell lymphoma. Akt inhibitor MK2206 may stop the growth...

Lapatinib Ditosylate and Akt Inhibitor MK2206 in Treating Women With Metastatic Breast Cancer

This phase I trial studies the side effects and the best dose of lapatinib ditosylate and Akt inhibitor MK2206 in treating women with metastatic breast cancer. Lapatinib ditosylate and Akt...

Dinaciclib and Akt Inhibitor MK2206 in Treating Patients With Pancreatic Cancer That Cannot Be Removed By Surgery

This randomized phase I trial studies the side effects and best dose of dinaciclib and Akt inhibitor MK2206 in treating patients with pancreatic cancer that cannot be removed by surgery. D...

PubMed Articles [41472 Associated PubMed Articles listed on BioPortfolio]

Salivary Tumour Necrosis Factor-α as a Biomarker in Oral Leukoplakia and Oral Squamous Cell Carcinoma.

Oral cancer is one of the life threatening disease which requires an availability of a biomarker for itsearly detection and also for effective treatment strategies. The current study is done to evalua...

A surface plasmon resonance immunoassay for the rapid analysis of methamphetamine in forensic oral fluid.

Current chromatographic methods applied for the forensic analysis of methamphetamine are costly, time-consuming, and require complicated pretreatment procedures. Thus, the rapid detection of methamphe...

Histologic analysis of medication-related osteonecrosis of the jaw compared with antiresorptive-exposed bone and other infectious, inflammatory, and necrotic jaw diseases.

This study characterized histologic features of medication-related osteonecrosis of the jaw (MRONJ) through analysis of tissues from patients and healthy individuals.

Combining Biomarker Calibration Data to Reduce Measurement Error.

Biomarker assay measurement often consists of a two-stage process where laboratory equipment yields a relative measure which is subsequently transformed to the unit of interest using a calibration cur...

Bioinformatic screening and experimental analysis identify SFRP1 as a prognostic biomarker for tongue squamous cell carcinomas.

To provide a prognostic biomarker and a potential therapeutic target for tongue squamous cell carcinoma (TSCC).

Medical and Biotech [MESH] Definitions

Laboratory processes prior to specimen analysis. These processes include study design, compliance of the subjects investigated, compliance in adherence to protocols, choice of specimens utilized and sample collection.

Techniques which study entities using their topological, geometric, or geographic properties and include the dimension of time in the analysis.

A type of analysis in which subjects in a study group and a comparison group are made comparable with respect to extraneous factors by individually pairing study subjects with the comparison group subjects (e.g., age-matched controls).

Absolute, comparative, or differential costs pertaining to services, institutions, resources, etc., or the analysis and study of these costs.

A set of techniques used when variation in several variables has to be studied simultaneously. In statistics, multivariate analysis is interpreted as any analytic method that allows simultaneous study of two or more dependent variables.

More From BioPortfolio on "INCB18424 in Treating Young Patients With Relapsed or Refractory Solid Tumor, Leukemia, or Myeloproliferative Disease"

Quick Search

Relevant Topics

Cancer
  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...


Searches Linking to this Trial