A phase I/II trial testing nelfinavir, an inhibitor of Akt signaling, in combination with preoperative chemoradiotherapy in patients with locally advanced rectal cancer - nelfinavir phase I/II

• Conditions: A phase I/II trial testing nelfinavir, an inhibitor of Akt signaling, in combination with preoperative chemoradiotherapy with locally advanced rectal cancer; MedDRA version: 9.1Level: PTClassification code 10038050Term: Rectal cancer stage III; MedDRA version: 9.1Level: PTClassification code 10038051Term: Rectal cancer stage IV

• Registration Number: EUCTR2007-000728-41-NL
• Lead Sponsor: Maastro clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-16
• Last Update Posted: 6 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

•Histologically proven adenocarcinoma of the rectum (tumor <15cm from anal verge)
•Age >= 18 years
•UICC T3-4 N0-2 M0
•WHO performance status 0-2
•Less than 10 % weight loss the last 6 months
•No recent (< 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction)
•Normal serum bilirubin 3x normal
• ASAT and ALAT 2,5x normal
• creatinin clearance >50 ml/min
•Willing and able to comply with the study prescriptions
•No history of prior pelvic radiotherapy
•No known HIV infection
• No hemophilia
•No concurrent medication that is metabolized by the CYP3A4 isoenzyme (calcium channel blockers, antifungal agents, macrolide antibiotics, gastrointestinal prokinetics, terfenadin, midazolam)
•Statins should be stopped (except pravastatin and fluvastatin),
•No concurrent use of St. John’s Wort (Hypericum perforatum)
•Being willing and able to undergo one extra biopsy
•Have given written informed consent before patient registration

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The opposite of the above.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified