An Extension Study for Patients Previously Enrolled in Studies With Pelabresib

Part of paid clinical trials in Los Angeles, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06401356
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Malignancies
  • Hematologic Malignancy
  • Solid Tumor

Eligibility Criteria

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

Interventions

  • Pelabresib — DRUG
    Small molecule inhibitor of bromodomain and extraterminal (BET) protein

Study Details

The purpose of this study is to evaluate the long-term safety and the clinical benefit of pelabresib in patients with hematological and/or solid tumor indications or advanced malignancies. Additionally, participants previously enrolled in studies with pelabresib who received placebo or participants who discontinued pelabresib (for any other reason than participating in this extension study), may be enrolled in this extension study to evaluate the survival and leukemia-free survival (for patients with hematological malignancies) or only the Survival Follow-up (for all the other patients).

Key Dates

Start date
Aug 13, 2024
Status verified
Jun 2026
Primary completion
Jun 2, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pelabresib
    All eligible participants will receive continued treatment with pelabresib as administered in the relevant parent study. Participants previously enrolled in studies with pelabresib who discontinued treatment with placebo or pelabresib may be enrolled in this extension study for the purpose of survival follow-up.

Primary Outcome Measure

Treatment-emergent adverse events (TEAEs) and serious TEAEs [ Time Frame: 5 years ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of California LALos AngelesCalifornia90095
Nicole Alimi NP
[email protected]
310-825-5513
Gary Schiller (PRINCIPAL_INVESTIGATOR)
Mayo Clinic JacksonvilleJacksonvilleFlorida32224
Tina Kothare
[email protected]
904-953-6153
Candido Rivera (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60611
Gabby Perea
[email protected]
312-695-1371
Brady L Stein (PRINCIPAL_INVESTIGATOR)
Uni Of Michigan Health SystemAnn ArborMichigan48109
Hayley Demchak
[email protected]
Moshe Talpaz (PRINCIPAL_INVESTIGATOR)
Mt Sinai Medical CenterNew YorkNew York10029-6574
Carly Sullivan
[email protected]
347-714-3285
Marina Kremyanskaya (PRINCIPAL_INVESTIGATOR)
New York Presbyterian HospitalNew YorkNew York10021
Penina Stewart
[email protected]
212-746-2932
Joseph Scandura (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
University of California LA· Los Angeles, CAMayo Clinic Jacksonville· Jacksonville, FLNorthwestern University· Chicago, ILUni Of Michigan Health System· Ann Arbor, MIMt Sinai Medical Center· New York, NYNew York Presbyterian Hospital· New York, NY

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