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NCT02346370 · ClinicalTrials.gov registry record · Phase 1
A Phase 1b Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) Combined With Docetaxel in Subjects With Recurrent Previously Treated Locally Advanced or Metastatic NSCLC
A Phase 1 study, sponsored by Halozyme Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT02346370 is a Phase 1 study that was terminated before completion, run by Halozyme Therapeutics. The registered enrollment target is 16 participants.
The verdict
NCT02346370, a Phase 1 study, was terminated before completion, sponsored by Halozyme Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
A Phase 1b study for participants with Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) to participate in 1 of 2 portions of this study. The first portion is Dose Escalation in which participants are tested with PEGPH20 at various doses (1.6, 3.0, 2.2 and 2.8 micrograms/kilogram (ug/kg)) in addition to dosing with the standard dose of docetaxel (PDoc) of 75 milligrams/meter squared (mg/m\^2) once every 21-day cycle. Based on observations on the safety and tolerability of study treatment from dose escalation cohorts dosed to date (1.6 and 3.0 ug/kg of PEGPH20), two additional dose levels will be tested, 2.2 and 2.8 ug/kg. Up to 30 additional participants may be enrolled to test these dose levels. The second portion of Phase 1b is Cohort Expansion in which the recommended Phase 2 dose (RP2D) of PDoc identified in dose escalation is administered every 21 days to approximately 50 participants with high hyaluronan (HA-high) prospectively measured in their tumor tissue.
Interventions
- DRUG Docetaxel
- DRUG PEGylated recombinant human hyaluronidase PH20
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2015-02-10 |
| Est. Completion | 2016-11-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02346370
The ClinicalTrials.gov registry entry for NCT02346370 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Halozyme Therapeutics, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Docetaxel is the first listed.
NCT02346370 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02346370 about?
NCT02346370 is a clinical study titled "A Phase 1b Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) Combined With Docetaxel in Subjects With Recurrent Previously Treated Locally Advanced or Metastatic NSCLC". A Phase 1b study for participants with Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) to participate in 1 of 2 portions of this study. The first portion is Dose Escalation in which participants are tested with PEGPH20 at various doses (1.6, 3.0, 2.2 and 2.8 micrograms/kilogram (ug/kg)) in addition...
What is the current status of trial NCT02346370?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2015-02-10. Estimated completion is 2016-11-14.
What interventions are being tested in trial NCT02346370?
The interventions under investigation include: Docetaxel (DRUG), PEGylated recombinant human hyaluronidase PH20 (DRUG).
Who is sponsoring clinical trial NCT02346370?
This trial is sponsored by Halozyme Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
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