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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: Clinical Trial Phase 1 study, sponsored by Halozyme Therapeutics.
NCT02346370 is a Phase 1 study that was terminated before completion, run by Halozyme Therapeutics. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
DLTs were defined as adverse events (AEs) that occurred during Cycle 1 in the Dose Escalation portion of the study, and deemed by the Investigator as related to study treatment.
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 |
Why NCT02346370 stopped before completion
NCT02346370 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Docetaxel is the first listed.
NCT02346370 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02346370's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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