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NCT01822756 · ClinicalTrials.gov registry record · Phase 1
An Open-Label Study of Ruxolitinib Given With Chemotherapy in Patients With Advanced Solid Tumors
A Phase 1 study, sponsored by Incyte Corporation.
- Terminated
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT01822756 is a Phase 1 study that was terminated before completion, run by Incyte Corporation. The registered enrollment target is 42 participants.
The verdict
NCT01822756, a Phase 1 study, was terminated before completion, sponsored by Incyte Corporation.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
This is a study of ruxolitinib in combination with gemcitabine with or without nab-paclitaxel administered to patients with advanced or metastatic pancreatic cancer. The study will be conducted in two parts. Part 1 of the study will evaluate the safety, tolerability and pharmacokinetics (PK) of ruxolitinib when given as described to patients with advanced or metastatic pancreatic cancer. A goal of Part 1 will be to identify the maximally tolerated dose (MTD) of ruxolitinib when given with gemcitabine with or without nab-paclitaxel. This dose will be selected for use in Part 2 of the study. Part 2 of the study will further evaluate the safety, tolerability, PK and preliminary clinical activity of ruxolitinib at the dose defined in Part 1 used in combination with gemcitabine with or without nab-paclitaxel in subjects with advanced or metastatic pancreatic cancer. After multiple challenges of trial conduct, by mutual agreement between investigators and sponsor, dose escalation ended after Cohort B1, RUX 10 mg twice daily (BID) - GCSF in October 2014. Therefore, the MTD was not reached. No safety issues led to the decision to stop further enrollment. Because of the early study termination, samples for pharmacokinetics and pharmacodynamics, and computed tomography for tumor burden were collected, but not analyzed; analysis data are not available. The data cutoff for this posting is 22 SEP 2015. As of the data cutoff, 1 subject was receiving treatment in the study and had been enrolled for 47 weeks. This subject had their end of treatment visit in AUG 2016. A comparison of this subjects' safety data after the cutoff date showed no clinically meaningful differences (eg, adverse events) compared with safety results that are summarized here.
Interventions
- DRUG nab-paclitaxel
- DRUG gemcitabine
- DRUG ruxolitinib
- DRUG filgrastim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2013-04 |
| Est. Completion | 2016-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01822756
The ClinicalTrials.gov registry entry for NCT01822756 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 42 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 4 interventions - of which nab-paclitaxel is the first listed.
NCT01822756 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01822756 about?
NCT01822756 is a clinical study titled "An Open-Label Study of Ruxolitinib Given With Chemotherapy in Patients With Advanced Solid Tumors". This is a study of ruxolitinib in combination with gemcitabine with or without nab-paclitaxel administered to patients with advanced or metastatic pancreatic cancer. The study will be conducted in two parts. Part 1 of the study will evaluate the safety, tolerability and pharmacokinetics (PK) of rux...
What is the current status of trial NCT01822756?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2013-04. Estimated completion is 2016-08.
What interventions are being tested in trial NCT01822756?
The interventions under investigation include: nab-paclitaxel (DRUG), gemcitabine (DRUG), ruxolitinib (DRUG), filgrastim (DRUG).
Who is sponsoring clinical trial NCT01822756?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
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