CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
Nelfinavir +1 moredrug
Likely dose
Nelfinavir 1250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01728779
NCT01728779Phase 2Completed
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Single-Arm Phase II Study of Stereotactic Body Radiation Therapy Concurrent With Nelfinavir for Oligometastases

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Nov 20, 2012·Updated Jul 12, 2021

In Brief

A Phase 2 clinical trial evaluating Nelfinavir and Stereotactic Body Radiation (SBRT) for Oligometastases. Completed, enrolled 38 participants across 1 site.

Detailed Summary

Patients with metastatic lesions of the lung, liver, or bone will be candidates for treatment. Within three weeks of the initial treatment planning, a 15 Gy dose (per lesion site) of SBRT will be administered. Prior to SBRT, patients will initiate Nelfinavir oral therapy twice daily for 7 days. Once SBRT is completed, the patient will repeat the same Nelfinavir therapy for an additional 7 days for a total of 14 days of treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOligometastases
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 20, 2012
Enrollment StartJan 8, 2014
Primary CompletionMar 1, 2020
Study CompletionDec 1, 2020
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 13.6 years ago

Interventions

Nelfinavirdrug

Commercially available nelfinavir (1250 mg) will be administered orally twice daily for 14 days.

Stereotactic Body Radiation (SBRT)radiation

15 Gy dose (per lesion site) of SBRT will be administered