Clinical trial · Interventional
Study of Nelfinavir and Temsirolimus in Patients With Advanced Cancers
Phase I Study of Nelfinavir in Combination With Temsirolimus in the Treatment of Patients With Advanced Cancers, Including Second Line Renal Cell Cancer
- 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)
In the present study the investigators want to explore the safety, pharmacokinetics, and activity of the combination of temsirolimus and nelfinavir, both agents with PI3K /Akt/mTOR inhibiting activity, in patients with advanced malignancies.Temsirolimus has proven anti tumoral activity by mTOR inhibition. Nelfinavir is a potential inhibitor of Akt. Combining both agents might prevent upregulation of the P13k pathway and increase the anti-cancer activity of temsirolimus. The strong CYP3A4 inhibition of nelfinavir and the dependence of temsirolimus on CYP3 A4 metabolism makes a dose finding study essential. The investigators will also look at the prospective value of biomarkers of activity and the outcome of the treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nelfinavir and temsirolimus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- nelfinavir and temsirolimus
- description
- dose escalation
- interventionNames
- Drug: Nelfinavir and temsirolimus
Primary outcomes (2)
- measure
- Pharmacokinetics/pharmacodynamics
- timeFrame
- During the first 5 weeks of treatment
- description
- PK Nelfinavir: D1, 11, 18, 25, 32 PK Temsirolimus: D4, 11, 18, 25,32
- measure
- Toxicity profile
- timeFrame
- Day1 -Day90
- description
- Collection of clinical data according to CTC toxicity criteria
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histological or cytological confirmed malignancies * ECOG / WHO performance status of 0-2 * Age 18 years * Life expectancy of at least 3 months * Minimal acceptable safety laboratory values defined as * WBC 3.0 x 109 /L * Platelet count 100 x 109 /L * Hepatic function as defined by serum bilirubin 1.5 x ULN, ALT or AST 2.5 x ULN, in case of liver metastases 5 x ULN * Renal function as defined by creatinine \< 150μmol/L * Able and willing to give written informed consent according to ICH/GCP, and national/local regulations. * Able to swallow and retain oral medication * Able and willing to undergo blood sampling for pharmacokinetic and pharmacogenetic analysis * Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial Exclusion Criteria: * Patients with known alcoholism, drug addiction and/or psychotic disorders in the history that are not suitable for adequate follow up * Women who are pregnant or breast feeding * Women of childbearing potential who refuse to use a reliable contraceptive method throughout the study * Serious concomitant systemic disorder that would compromise the safety of the patient, at the discretion of the investigator * Any other medical condition that would interfere with study procedures and/or decrease safety of the protocol treatment * Concomitant use of strong CYP3A4 inhibitors, CYP3A4 inducers or CYP substrates
References
Publications (0)
Data not yet available