ZEN003694 Combined With Niraparib in Patients With Metastatic or Recurrent Solid Tumors

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Haider Mahdi
Study ID
NCT06161493
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • ZEN003694 — DRUG
    A bromodomain extra-terminal inhibitor (BETi) that blocks a group of proteins called bromodomain and extra-terminal (BET), which may counteract the effect of NSD3 on tumor growth.
  • Niraparib — DRUG
    An anti-cancer medication (PARP inhibitor) used for the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer .

Study Details

This Phase I, open label, dose determining study of oral niraparib in combination with ZEN003694 given daily in 28-day cycles will enroll patients with metastatic or recurrent solid cancer. Dose escalation will follow the mTPI-2/Keyboard design. Eligible patients will receive therapy until disease progression or unacceptable toxicities are experienced.

Key Dates

Start date
Jan 23, 2024
Status verified
Oct 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2029

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Niraparib
    ZEN003694: Oral capsules - Starting dose 36 mg Dose escalated to 48 mg, following the mTPI-2/Keyboard design administered orally once daily in 28-day cycles Niraparib: Oral tablets - Starting dose 100 mg Dose escalated to 200 mg, following the mTPI-2/Keyboard design administered once daily at the same time as ZEN003694

Primary Outcome Measure

Treatment-related Adverse Events (AE) and Serious Adverse Events (SAE) [ Time Frame: Up to 36 months (study population) ]

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Magee Womens HospitalPittsburghPennsylvania15213-

Find similar trials in Pittsburgh, PA

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
UPMC Magee Womens Hospital· Pittsburgh, PA

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