Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT05450965
Phase
PHASE2
Status
Recruiting
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Conditions

  • Small Cell Lung Carcinoma
  • Small-cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Onvansertib — DRUG
    Onvansertib at a dose of 15 mg/m2 orally on Days 1-14 of a 21-day cycle. Treatment will continue until disease progression or intolerable toxicity.

Study Details

This phase II clinical trial will study the safety and efficacy of onvansertib to treat patients with small cell lung cancer (SCLC) who have either not responded to or are unable to tolerate chemotherapy. Onvansertib is a drug that inhibits polo-like kinase 1 (PLK-1), an enzyme that is over-expressed in many cancer cells and is involved in cellular repair.

Key Dates

Start date
Jul 19, 2022
Status verified
Dec 2025
Primary completion
Aug 31, 2027
Completion
Nov 30, 2027

Study Design

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

Arms

  • Experimental: Single Treatment Arm
    Onvansertib

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to 42 months (cohort) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Maryland Greenebaum Comprehensive Cancer CenterBaltimoreMaryland21201
Taofeek Owonikoko, MD, PhD
Taofeek Owonikoko, MD, PhD (PRINCIPAL_INVESTIGATOR)
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-

Find similar trials in Baltimore, MD

By research site
University of Maryland Greenebaum Comprehensive Cancer Center· Baltimore, MDUPMC Hillman Cancer Center· Pittsburgh, PA

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