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NCT01505153 · ClinicalTrials.gov registry record · Phase 1
Phase I Intratumoral Pbi-shRNA STMN1 LP in Advanced and/or Metastatic Cancer
A Phase 1 study, sponsored by Gradalis.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01505153 is a Phase 1 study that has completed, run by Gradalis. The registered enrollment target is 20 participants.
The verdict
NCT01505153, a Phase 1 study, has completed, sponsored by Gradalis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This is a Phase I safety trial of bifunctional shRNA-STMN1 (pbi-shRNA™STMN1) BIV (bilamellar invaginated vesicle) lipoplex (LP), pbi-shRNA™ STMN1 LP administered by a single intratumoral (IT) injection. Patients with superficially accessible advanced cancer following prior therapies will be entered into the study following a modified dose escalation design based on the demonstrated safety of our previous clinical experience (BB-IND 13744) with the same liposome and vector DNA backbone expressing a different transgene (of which doses up to 7 mg DNA IV/single dose have been administered). Patients will accrue in 4-patient escalation cohorts using a modified Fibronacci escalation schema (100%-50%-33%-33%) at a starting intratumoral dose of 0.010 mg/kg of DNA through a dose of 0.053 mg/kg DNA intratumoral / single dose. Should a single, but not more than two (2), ≥ Grade 3 Dose Limiting Toxicity (DLT) occur in any cohort, following mandated review (see below) an additional two (2) patients will be accrued at that dose (total of six). If more than one ≥ Grade 3 toxicity occurs in any cohort, the preceding dose cohort will be expanded to six (from four) and if \< 2/6 patients experience ≥ Grade 3 toxicity, that dose will be the Phase II recommended dose. Should no ≥ Grade 3 toxicity occur in any cohort (other than Grade 3 local injection site reaction), an additional two (2) patients will be treated at 0.053 mg/kg DNA intratumoral / single dose.
Interventions
- BIOLOGICAL pbi-shRNA STMN1 LP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2012-02 |
| Est. Completion | 2017-04-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01505153
The ClinicalTrials.gov registry entry for NCT01505153 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gradalis, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which pbi-shRNA STMN1 LP is the first listed.
NCT01505153 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01505153 about?
NCT01505153 is a clinical study titled "Phase I Intratumoral Pbi-shRNA STMN1 LP in Advanced and/or Metastatic Cancer". This is a Phase I safety trial of bifunctional shRNA-STMN1 (pbi-shRNA™STMN1) BIV (bilamellar invaginated vesicle) lipoplex (LP), pbi-shRNA™ STMN1 LP administered by a single intratumoral (IT) injection. Patients with superficially accessible advanced cancer following prior therapies will be entered ...
What is the current status of trial NCT01505153?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2012-02. Estimated completion is 2017-04-13.
What interventions are being tested in trial NCT01505153?
The interventions under investigation include: pbi-shRNA STMN1 LP (BIOLOGICAL).
Who is sponsoring clinical trial NCT01505153?
This trial is sponsored by Gradalis, which has 13 total clinical trials registered on ClinicalTrials.gov.
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