A Study Evaluating Safety and Tolerability, and Pharmacokinetics of Navitoclax Monotherapy and in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasm

Part of paid clinical trials in Duarte, California.

Sponsor
AbbVie
Study ID
NCT04041050
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Myeloproliferative Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Navitoclax — DRUG
    Tablet; Oral
  • Ruxolitinib — DRUG
    Tablet; Oral
  • Celecoxib — DRUG
    Capsule; Oral

Study Details

There are 5 parts to this study for which the primary objectives are to evaluate safety, tolerability, and pharmacokinetics (PK) of navitoclax when administered alone (Part 1) or when administered in combination with ruxolitinib (Part 2). In Part 2, participants must have been receiving a stable dose of ruxolitinib therapy for at least 12 weeks prior to study enrollment. In Part 3, all eligible participants will receive navitoclax, with the primary objective being to evaluate potential navitoclax effect on QTc prolongation. In Part 4, effect of navitoclax is evaluated on the PK, safety, and tolerability of a single dose of celecoxib. In Part 5, all eligible participants will receive ruxolitinib twice daily and navitoclax once daily for drug-drug interaction (DDI) assessment, followed by continued administration of navitoclax in combination with ruxolitinib.

Key Dates

Start date
Nov 8, 2019
Status verified
Jun 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
85 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Navitoclax Monotherapy
    Participants will receive various doses of navitoclax once daily (QD).
  • Experimental: Part 2: Navitoclax + Ruxolitinib Combination Therapy
    Participants will receive various doses of navitoclax once daily (QD) in combination with ruxolitinib twice daily (BID).
  • Experimental: Part 3: Navitoclax Monotherapy
    Participants will receive navitoclax once daily (QD).
  • Experimental: Part 4: Navitoclax + Celecoxib
    Participants will receive navitoclax once daily (QD) starting on Day 3. Participants will also receive celecoxib single dose on Day 1 and Day 7.
  • Experimental: Part 5: Navitoclax + Ruxolitinib Combination Therapy
    Participants will receive ruxolitinib BID and navitoclax QD for drug-drug interaction (DDI) assessment, followed by continued administration of navitoclax in combination with ruxolitinib.

Primary Outcome Measure

Number of Participants with Dose Limiting Toxicities (DLT) (Part 1 and Part 2) [ Time Frame: Up to 28 days after the navitoclax initiation ]

Locations (12)

FacilityCityStateZIPSite coordinators
City of Hope /ID# 239769DuarteCalifornia91010-
Providence - St. Jude Medical Center /ID# 242558FullertonCalifornia92835-
Moores Cancer Center at UC San Diego /ID# 229584La JollaCalifornia92093-
UCLA /Id# 222784Los AngelesCalifornia90095-1678-
Northwestern University Feinberg School of Medicine /ID# 224203ChicagoIllinois60611-2927-
Norton Cancer Institute - St. Matthews /ID# 239300LouisvilleKentucky40207-
Duplicate_Brigitte Harris Cancer Pavilion /ID# 238686DetroitMichigan48202-2610-
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 242554OmahaNebraska68130-
Duplicate_East Carolina University Brody School of Medicine /ID# 238560GreenvilleNorth Carolina27834-
Gabrail Cancer Center Research /ID# 228924CantonOhio44718-
Pennsylvania Cancer Specialists Research Institute - Gettysburg /ID# 242550GettysburgPennsylvania17325-
Virginia Commonwealth University Medical Center Main Hospital /ID# 228169RichmondVirginia23219-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAProvidence - St. Jude Medical Center· Fullerton, CAMoores Cancer Center at UC San Diego· La Jolla, CAUCLA· Los Angeles, CANorthwestern University Feinberg School of Medicine· Chicago, ILNorton Cancer Institute - St. Matthews· Louisville, KY

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