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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000728-41-NL

Enrollment

Registered

2008-09-16

Start date

2008-09-12

Completion date

Unknown

Last updated

2013-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 9.1 Level: PT Classification code 10038050 Term: Rectal cancer stage III MedDRA version: 9.1 Level: PT Classification code 10038051 Term: Rectal cancer stage IV

Interventions

Trade Name: Viracept 250 Product Name: Viracept 250 Product Code: 1373661 Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Histologically proven adenocarcinoma of the rectum (tumor = 18 years • UICC T3-4 N0-2 M0 • WHO performance status 0-2 • Less than 10 % weight loss the last 6 months • No recent (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

Exclusion criteria: The opposite of the above.

Design outcomes

Primary

Measure	Time frame
Main Objective: 2.1 Primary objective To investigate the safety and the activity of nelfinavir, administered before and during preoperative chemoradiotherapy, 28x1.8 Gy in combination with Xeloda 825 mg/m2 BID, in patients with locally advanced rectal carcinoma. ;Secondary Objective: 2.2 Secondary Objectives • To describe the toxicity of the combined regimen studied. • To gain insight into the mechanism of interaction of this treatment combination by means of translational research. ;Primary end point(s): Primary end-point Incidence of any grade 3 or higher non-hematological or grade 4 or higher hematological toxicity (according to CTCAE v3.0) and incidence of grade 4 or higher postoperative toxicity within 30 days post-surgery (see chapter 5). Secondary end-points 1. The rate of pathological Complete Remission (pCR) 2. Histopathologic negative circumferential resection margin (CRM) rate 3. Local and distance recurrence rate 4. Progression free and overall survival 5. Metabolic Response rate at CT-PET at time of surgery 6. Phosphorylation of Akt in the tumor at 3 different time points (chapter 9) 7. Tumor perfusion assessed by dynamic CT-scan (chapter 9)	—

Measure

Time frame

Main Objective: 2.1 Primary objective To investigate the safety and the activity of nelfinavir, administered before and during preoperative chemoradiotherapy, 28x1.8 Gy in combination with Xeloda 825 mg/m2 BID, in patients with locally advanced rectal carcinoma. ;Secondary Objective: 2.2 Secondary Objectives • To describe the toxicity of the combined regimen studied. • To gain insight into the mechanism of interaction of this treatment combination by means of translational research. ;Primary end point(s): Primary end-point Incidence of any grade 3 or higher non-hematological or grade 4 or higher hematological toxicity (according to CTCAE v3.0) and incidence of grade 4 or higher postoperative toxicity within 30 days post-surgery (see chapter 5). Secondary end-points 1. The rate of pathological Complete Remission (pCR) 2. Histopathologic negative circumferential resection margin (CRM) rate 3. Local and distance recurrence rate 4. Progression free and overall survival 5. Metabolic Response rate at CT-PET at time of surgery 6. Phosphorylation of Akt in the tumor at 3 different time points (chapter 9) 7. Tumor perfusion assessed by dynamic CT-scan (chapter 9)

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026