A phase I, first in man study of OSI-7836 in patients with advanced refractory solid tumors: IND.147, a study of the Investigational New Drug Program of the National Cancer Institute of Canada Clinical Trials Group

Cancer Chemotherapy and Pharmacology
G GossInvestigational New Drug Program of the National Cancer Institute of Canada Clinical Trials Group

Abstract

To determine the maximum tolerated dose (MTD), recommended phase II dose (RP2D), safety, tolerability, toxicity profile, dose-limiting toxicities (DLTs), anti-tumor activity and pharmacokinetics of OSI-7836 given IV on day 1 and day 8 every 3 weeks in patients with advanced incurable cancer. Twenty-seven previously treated patients with advanced or metastatic solid tumors were enrolled in this phase I study conducted by the National Cancer Institute of Canada Clinical Trial Group (NCIC CTG). OSI-7836 was administered IV on day 1 and day 8 every 3 weeks. The dose was initially escalated from 100 to 600 mg/m2 and finally de-escalated to 200 mg/m2 in seven cohorts of patients. Patients were evaluated every other cycle of treatment for radiological response. Pharmacokinetics were performed on day 1 and day 8 of cycle 1 for all patients. Twenty-six patients were evaluable for toxicity. All patients experienced reversible Grade 3 lymphopenia beginning at cycle 1. The maximal delivered dose was 600 mg/m2. MTD was reached at 400 mg/m2. DLTs included fever, fatigue, rash, herpes simplex infection, nausea and vomiting. The RP2D was 200 mg/m2. No objective responses were seen in 21 evaluable patients. Pharmacokinetics were dose proportion...Continue Reading

References

Nov 11, 1992·Investigational New Drugs·D F MooreJ L Abbruzzese
Jan 15, 1971·The Journal of Organic Chemistry·R L WhistlerU G Nayak
Aug 6, 1997·Journal of the National Cancer Institute·R SimonM C Christian
Jan 11, 2002·The New England Journal of Medicine·Joan H SchillerUNKNOWN Eastern Cooperative Oncology Group
Feb 27, 2003·The Journal of Pharmacology and Experimental Therapeutics·Hitoshi SomeyaWilliam B Parker
Apr 8, 2003·Cancer Chemotherapy and Pharmacology·William R WaudJohn A Secrist
Dec 14, 2004·Cancer Chemotherapy and Pharmacology·Frank RichardsonRaymond Bendele
May 6, 2006·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Chooi P LeeJaap Verweij

❮ Previous
Next ❯

Citations

Nov 13, 2008·Cancer Chemotherapy and Pharmacology·William B ParkerWilliam R Waud
Feb 16, 2011·Expert Opinion on Investigational Drugs·Tadeusz Robak
Oct 16, 2013·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Arif ManjiAlbiruni R Abdul Razak
Apr 8, 2006·Onkologie·Jonathan L Kaufman, Sagar Lonial
Jun 19, 2008·Journal of Nursing Management·Pirjo Sirola-Karvinen, Kristiina Hyrkäs
Mar 3, 2011·European Journal of Nuclear Medicine and Molecular Imaging·Luigi Mansi, Irene Virgolini
May 6, 2006·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Chooi P LeeJaap Verweij

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.