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NCT01445106 · ClinicalTrials.gov registry record · Phase 1
A Phase I Trial of Nelfinavir (Viracept ) in Adults With Solid Tumors
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT01445106: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01445106 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 28 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01445106, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
Background: * The PI3K/Akt/mTOR pathway is an important target in cancer because it promotes chemotherapeutic resistance and confers a poor prognosis for many types of cancers. * Several inhibitors of the pathway are being developed as cancer therapeutics. However, the process of de novo drug development takes years, and is often curtailed due to diminished activity and/or unforeseen toxicities in clinical trials. * One approach to expedite the development of new cancer therapies is to test drugs that are already approved for other indications. * Our group has shown that nelfinavir, an orally available FDA-approved HIV-1 protease inhibitor used to treat HIV/AIDS, can inhibit endogenous Akt and growth factor receptor induced Akt activity in cancer cells. * Importantly, nelfinavir demonstrates dose-dependent cytotoxicity in every cell line in the NCI 60 cell line panel at plasma concentrations attainable in human plasma, is profoundly effective in cancer cell lines that have been selected to become resistant to standard therapies, and inhibits tumor growth in-vivo. Objectives: * Because an MTD with nelfinavir has not been observed in prior phase I studies with HIV patients, the objectives of the Phase I design will be: * To establish the MTD and dose limiting toxicity for this drug in patients with solid Tumors. * To correlate nelfinavir pharmacokinetics with baseline activity of CYP3A4 as assessed by measuring midazolam clearance. * To preliminarily explore the biological and clinical effects through a series of correlative studies involving analysis of blood and tissue across patients throughout the study. Eligibility: -Adults with solid tumors who are refractory to, or have relapsed after receiving, standard front-line chemotherapies are eligible. Design: * Patients will receive nelfinavir beginning at the FDA-approved dose for HIV patients (1250 mg po bid). * Dose escalations will occur for 6 dose levels i.e. cohorts, or until the MTD is reached. * Up to 45
Interventions
- DRUG Nelfinavir
- DRUG Nelfinavir Mesylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2006-12-11 |
| Est. Completion | 2011-05-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01445106
The ClinicalTrials.gov registry entry for NCT01445106 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nelfinavir is the first listed.
NCT01445106 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01445106 about?
NCT01445106 is a clinical study titled "A Phase I Trial of Nelfinavir (Viracept ) in Adults With Solid Tumors". Background: * The PI3K/Akt/mTOR pathway is an important target in cancer because it promotes chemotherapeutic resistance and confers a poor prognosis for many types of cancers. * Several inhibitors of the pathway are being developed as cancer therapeutics. However, the process of de novo drug devel...
What is the current status of trial NCT01445106?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2006-12-11. Estimated completion is 2011-05-09.
What interventions are being tested in trial NCT01445106?
The interventions under investigation include: Nelfinavir (DRUG), Nelfinavir Mesylate (DRUG).
Who is sponsoring clinical trial NCT01445106?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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