Clinical trial · Interventional
Nelfinavir, a Phase I/Phase II Rectal Cancer Study
A Phase I/II Trial Testing Nelfinavir, an Inhibitor of Akt Signaling, in Combination With Preoperative Chemoradiotherapy in Patients With Locally Advanced Rectal Cancer
NCT00704600CI-TRIAL-00016273NelfinavircompletedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim is to study safety and activity of nelfinavir , added to standard chemoradiotherapy in patients with locally advanced rectal cancer. Furthermore analysis of the effect of nelfinavir combined with chemoradiation on tumour tissue will be studied
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Carcinoma | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Tumors | Colorectal Neoplasm | ALIAS | 0.90 |
| Neoplasms, Colorectal | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nelfinavir | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- nelfinavir
- description
- see intervention
- interventionNames
- Drug: nelfinavir
Primary outcomes (1)
- measure
- phase I: Incidence of any grade 3 or higher non-hematological or grade 4 or higher hematological toxicity (CTCAE v3.0) and of grade 4 or higher postoperative toxicity within 30 days post-surgery phase II:rate of pathological complete remission
- timeFrame
- 22 wks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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) * Serum bilirubin = or \< 3x normal * ASAT and ALAT = or \< 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) * Women should not be pregnant or lactating * Being willing and able to undergo one extra biopsy * Have given written informed consent before patient registration Exclusion Criteria: * the opposite of the above
References
Publications (0)
Data not yet available
No reference posted for this study.