Related Experiment Videos
Su-6668. SUGEN
1Novartis Pharma AG, Department of Oncology, Basel, Switzerland. doriano.fabbro@pharma.novartis.com
Abstract:
SUGEN is developing SU-6668, a tyrosine kinase inhibitor that inhibits three distinct growth factor receptor targets, for the potential treatment of cancer [304530]. The compound is in phase I trials in the UK and US [321260], [374505]. A report in January 2001 stated that phase I/II trials for hematological and solid tumors were expected to commence shortly thereafter [395657]. In May 2001, phase I data from a dose-escalation study conducted at UCLA were presented at the 37th ASCO meeting in San Francisco, CA. By that time, 74 patients had been enrolled in this study which aimed to determine the toxicities of SU-6668 when delivered to fed and fasting patients. SU-6668 was administered orally either once or twice-daily at doses of 100 to 2400 mg/m2 to patients diagnosed as having advanced malignancies. Accrual in phase I is continuing to define the toxicities of doses > 200 mg/m2 twice-daily [409984], [411418]. In December 1998, SUGEN filed an IND with the FDA for the clinical testing of this compound with oral and iv formulations [310237]. In November 1998, SUGEN entered into a collaboration with the Cancer Research Campaign (CRC) to conduct a phase I trial of SU-6668 at the Royal Marsden Hospital, UK using an iv formulation [304530]. After the first six patients had been treated, the trial was halted owing to problems with the iv formulation. Some toxicities, including nausea, vomiting, fatigue and tumor pain were observed [413538]. No licensing agreement as involved between the CRC and SUGEN for this trial [408572].
Insights
SU-6668, a novel tyrosine kinase inhibitor, is undergoing Phase I trials for advanced cancers. Early data is assessing oral administration safety and toxicity in fed and fasting patients.
Area of Science:
- Oncology
- Pharmacology
Background:
- SUGEN is developing SU-6668, a tyrosine kinase inhibitor targeting three growth factor receptors.
- SU-6668 is being investigated for the potential treatment of various cancers.
Purpose of the Study:
- To determine the toxicities of SU-6668 in patients with advanced malignancies.
- To evaluate SU-6668 administered orally to fed and fasting patients.
Main Methods:
- Phase I dose-escalation study involving oral administration of SU-6668.
- Doses ranged from 100 to 2400 mg/m2, once or twice daily.
- 74 patients were enrolled in the study at UCLA.
Main Results:
- Accrual is ongoing to define toxicities at doses > 200 mg/m2 twice-daily.
- An earlier IV formulation trial was halted due to formulation issues and observed toxicities like nausea and vomiting.
Conclusions:
- Phase I trials are ongoing to establish the safety profile of orally administered SU-6668.
- Further studies are needed to define maximum tolerated doses and potential therapeutic benefits.