Clinical trial NCT02921919: Open-Label Extension and Safety Study of Talazoparib
Official title: A SINGLE-ARM, OPEN-LABEL, MULTICENTER, EXTENDED TREATMENT, SAFETY STUDY IN PATIENTS TREATED WITH TALAZOPARIB
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Medivation, Inc.
First posted: 2016-10-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single-arm, open-label, extended treatment, safety study in patients treated with talazoparib in qualifying studies.


Eligibility criteria: Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
* Female patients of childbearing potential must have a negative pregnancy test before the first dose of talazoparib and must agree to use a highly effective birth control method from the time of the first dose of talazoparib through 45 days after the last dose.
* Male patients must use a condom when having sex with a pregnant woman or with a woman of childbearing potential from the time of the first dose of talazoparib through 105 days after the last dose. Contraception should be considered for a nonpregnant female partner of childbearing potential.
* Female patients may not be breastfeeding at the first dose of talazoparib and must not breastfeed during study participation through 45 days after the last dose of talazoparib.

Exclusion Criteria:

* Permanently discontinued from any Medivation sponsored study with talazoparib alone or in combination with another agent.
* Received an antineoplastic therapy or investigational agent after treatment with talazoparib in the originating protocol.
* Has a clinically significant cardiovascular, dermatologic, endocrine, gastrointestinal, hematologic, infectious, metabolic, neurologic, psychologic, or pulmonary disorder or any other condition, including excessive alcohol or drug abuse, or secondary malignancy, that may interfere with study participation in the opinion of the investigator.
* Diagnosis of myelodysplastic syndrome (MDS).

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Emergent Treatment Related AEs and Treatment Emergent Treatment Related SAEs
timeFrame: From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years)
measure: Number of Participants With Grade 3 or 4 TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4
timeFrame: From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years)
measure: Number of Participants With TEAEs Leading to Dose Reduction, Permanent Study Drug Discontinuation and Death
timeFrame: From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years)
measure: Number of Participants With Clinically Significant Laboratory Abnormalities: Liver Function Tests
timeFrame: From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years)
measure: Number of Participants With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Hematology Parameters
timeFrame: From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years)
measure: Number of Participants With NCI-CTCAE Grade 3/4 Postbaseline Laboratory Toxicities: Chemistry Parameters
timeFrame: From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years)
measure: Number of Participants With Clinically Significant Changes in Vital Signs and Weight
timeFrame: From start of study treatment up to 30 days after last dose of study treatment or before initiation of a new antineoplastic therapy, whichever occurred first (approximately maximum for 4.6 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Alhambra
country: United States
facility: UCLA Hematology/Oncology - Alhambra
state: California
city: Bakersfield
country: United States
facility: CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
state: California
city: Burbank
country: United States
facility: UCLA Hematology/Oncology - Burbank
state: California
city: Fullerton
country: United States
facility: St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
state: California
city: Los Angeles
country: United States
facility: UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.
state: California
city: Los Angeles
country: United States
facility: (IRB# 16-001189) Ronald Reagan UCLA Medical Center, Drug Information Center
state: California
city: Los Angeles
country: United States
facility: TRIO-US Central Administration
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology
state: California
city: Los Angeles
country: United States
facility: UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.
state: California
city: Pasadena
country: United States
facility: UCLA Hematology/Oncology - Pasadena
state: California
city: Porter Ranch
country: United States
facility: UCLA Hematology/Oncology - Porter Ranch
state: California
city: Santa Monica
country: United States
facility: UCLA Hematology/Oncology - Santa Monica
state: California
city: Torrance
country: United States
facility: UCLA Torrance Oncology
state: California
city: Valencia
country: United States
facility: UCLA Hematology/Oncology - Santa Clarita
state: California
city: Orlando
country: United States
facility: Orlando Health, Inc.
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Hospital West
state: Florida
city: Bloomington
country: United States
facility: IU Health Bloomington Hospital
state: Indiana
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology, Inc.
state: Indiana
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology, Inc.
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health Melvin and Bren Simon Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Investigational Drug Senvices
state: Indiana
city: Indianapolis
country: United States
facility: IU Health University Hospital
state: Indiana
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Hamilton
country: Canada
facility: Juravinski Cancer Clinic
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Marseille cedex 09
country: France
facility: Institut Paoli-Calmettes
city: Erlangen
country: Germany
facility: Frauenklinik des Universitaetsklinikums Erlangen
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont, Onkologiai Osztaly
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet "B" Belgyogyaszati-Onkologiai Osztaly es Klinikai Farmakologiai Osztaly
city: Chisinau
country: Moldova, Republic of
facility: Arensia Exploratory Medicine, Institutia Medico-Sanitara Publica Institutul Oncologic
city: Warszawa
country: Poland
facility: Szpital Lux Med
city: Moscow
country: Russian Federation
facility: FSBEI HE " First Moscow State Medical University n.a. I.M. Sechenov" of the MoH of the RF
city: Saint-Petersburg
country: Russian Federation
facility: Medical Technologies LLC
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
affiliation: Pfizer
name: Pfizer Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: