ZEN003694 Combined With Talazoparib in Patients With Recurrent Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAlexander B Olawaiye, MD
About this trial
This Phase 2, open label, study with safety lead in of oral talazoparib in combination with ZEN003694 given daily in 28-day cycles will enroll patients with recurrent ovarian, fallopian tube or primary peritoneal carcinoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Females age ≥ 18 years (at time of signing informed consent)
ECOG status 0 or 1
Pathologically documented ovarian, fallopian tube, or primary peritoneal carcinoma.
Prior therapy with PARPi either as maintenance or therapeutic settings.
Disqualifiers
Current or anticipated use of medications known to be strong inhibitors or inducers of CYP3A4 or substrates of CYP1A2 with narrow therapeutic windows. Strong inhibitors, inducers or substrates must be discontinued at least 7 days prior to the first administration of study drug.
Current or anticipated use within 7 days prior to the first administration of study drug, or during the study, of strong P-gp inhibitors.
Use of oral Factor Xa inhibitors (i.e., rivaroxaban, apixaban, betrixaban, edoxaban otamixaban, letaxaban, eribaxaban) and Factor IIa inhibitors (i.e., dabigatran). Low molecular weight heparin is allowed
Radiation to >25% of the bone marrow
Trial design
Design model
Single group
Treatments tested in this trial
ZEN003694
DrugZEN003694 has shown promising activity in the treatment of solid tumors and hematologic (blood) cancers by reducing the multiplication of cancer cells.
Talazoparib
DrugTalazoparib kills cancer cells by inhibiting and trapping the enzyme PARP, which is known to be involved in the development of many types of cancers.
Treatment groups
33 Participants
are divided into 1 treatment groupGroup A: ZEN003694 + TalazoparibExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Objective Response
Confirmed complete response or partial response by RECIST 1.1. Per RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time frame
Up to 48 monthsSecondary outcomes
1
Adverse events at least possibly related to treatment
Adverse Events which occur from first day of treatment, characterized by type, grade and relatedness to treatment according to CTCAE v5.0, considered to be possibly, probably or definitely related to study treatment.
Time frame
Up to 48 months2
Duration of Response
Time from start of response to documented disease progression by RECIST v1.1 or death due to any cause. Progression as defined by RECIST v1.1 for target lesions: Progressive Disease (PD): smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions: Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Time frame
Up to 48 months3
Progression-free survival (PFS)
Time from first response to to treatment until documented disease progression by RECIST v1.1 or death due to any cause. Progression as defined by RECIST v1.1 for target lesions: Progressive Disease (PD): smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). For non-target lesions: Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Time frame
Up to 6 years4
Overall survival (OS)
Overall survival (OS), defined as time from first dose of study treatment until death due to any cause.
Time frame
Up to 6 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Alexander B Olawaiye, MD
Lead sponsor
University of Pittsburgh
Sponsor institution
Pfizer
Collaborator
Zenith Epigenetics
Collaborator
Source ClinicalTrials.gov