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NCT02298153 · ClinicalTrials.gov registry record · Phase 1
A Study of Atezolizumab in Combination With Epacadostat in Subjects With Previously Treated Stage IIIB or Stage IV Non-Small Cell Lung Cancer and Previously Treated Stage IV Urothelial Carcinoma
A Phase 1 study, sponsored by Incyte Corporation.
- Terminated
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT02298153 is a Phase 1 study that was terminated before completion, run by Incyte Corporation. The registered enrollment target is 29 participants.
The verdict
NCT02298153, a Phase 1 study, was terminated before completion, sponsored by Incyte Corporation.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
This study evaluated the safety and tolerability of epacadostat (INCB024360) administered in combination with atezolizumab (MPDL3280A) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that were previously treated with platinum-based chemotherapy and Stage IV urothelial carcinoma who failed a platinum-based chemotherapy regimen. The study was conducted in two phases. The dose escalation phase did utilize a 3 + 3 design to identify the maximum tolerated dose (MTD) or a Pharmacologically Active Dose (PAD) of the combination. This was followed by a dose expansion phase, which was comprised of three cohorts. Expansion Cohorts 1 \& 2 will further evaluate the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics at the dose identified in phase one. Expansion Cohort 3 will evaluate the change in biomarker expression following treatment with epacadostat as monotherapy followed by epacadostat and atezolizumab administered in combination.
Interventions
- DRUG Atezolizumab
- DRUG Epacadostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2015-01-27 |
| Est. Completion | 2017-11-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02298153
The ClinicalTrials.gov registry entry for NCT02298153 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Incyte Corporation, which has 239 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Atezolizumab is the first listed.
NCT02298153 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02298153 about?
NCT02298153 is a clinical study titled "A Study of Atezolizumab in Combination With Epacadostat in Subjects With Previously Treated Stage IIIB or Stage IV Non-Small Cell Lung Cancer and Previously Treated Stage IV Urothelial Carcinoma". This study evaluated the safety and tolerability of epacadostat (INCB024360) administered in combination with atezolizumab (MPDL3280A) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that were previously treated with platinum-based chemotherapy and Stage IV urothel...
What is the current status of trial NCT02298153?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2015-01-27. Estimated completion is 2017-11-08.
What interventions are being tested in trial NCT02298153?
The interventions under investigation include: Atezolizumab (DRUG), Epacadostat (DRUG).
Who is sponsoring clinical trial NCT02298153?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
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