NCT02265510

An Open-Label Study of a Novel JAK-inhibitor, INCB052793, Given to Patients With Advanced Malignancies

A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB052793 in Subjects With Advanced Malignancies

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a study of INCB052793 given to patients with advanced malignancies that was to be conducted in three phases; Phase 1a (Monotherapy) and Phase 1b (Combination Therapy) and Phase 2 (Combination therapy of INCB052793 with azacitidine and itacitinib with azacitidine). Phase 1 had two parts; a dose escalation (Part 1) and an expansion (Part 2).

Conditions

• Solid Tumors
• Advanced Malignancies
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	INCB052793	Initial cohort dose of INCB052793 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria.
DRUG	gemcitabine	Gemcitabine administered intravenously over 30 minutes at the protocol-specified dose and frequency.
DRUG	nab-paclitaxel	nab-paclitaxel administered intravenously over 30 minutes at the protocol-specified dose and frequency.
DRUG	dexamethasone	Dexamethasone administered orally at the protocol-specified dose and frequency.
DRUG	Carfilzomib	Carfilzomib administered intravenously at the protocol-specified dose and frequency.
DRUG	bortezomib	Bortezomib administered intravenously or subcutaneously at the protocol-specified dose and frequency.
DRUG	lenalidomide	Lenalidomide administered orally at the protocol-specified dose and frequency.
DRUG	azacitidine	Azacitidine administered subcutaneously at the protocol-specified dose and frequency.
DRUG	INCB052793	INCB052793 tablets administered orally at the protocol specified dose strength and frequency.
DRUG	pomalidomide	Pomalidomide administered orally at the protocol-specified dose and frequency.
DRUG	INCB050465	INCB050465 tablets administered orally at the protocol specified dose strength and frequency.
DRUG	INCB039110	INCB039110 tablets administered orally at the protocol specified dose strength and frequency.

Timeline

• Start date: 2014-09-10
• Primary completion: 2019-02-27
• Completion: 2019-02-27
• First posted: 2014-10-16
• Last updated: 2020-04-17
• Results posted: 2020-04-17

Locations

14 sites across 1 country: United States