You are here

A Study to Assess the Effects of Talazoparib on Cardiac Repolarization in Patients With Advanced Solid Tumors

Last updated on December 5, 2018

FOR MORE INFORMATION
Study Location
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
Bakersfield, California, 93309 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Solid Tumor
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. At least 18 years of age and willing and able to provide informed consent.

2. Histologically or cytologically confirmed advanced solid tumor with no available
standard treatment options in the opinion of the investigator.

3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

4. Estimated life expectancy of ≥ 3 months.

5. Able to swallow the study drug, have no known intolerance to the study drug or
excipients, and comply with study requirements.

6. Female patients of childbearing potential must have a negative pregnancy test at
screening and must agree to use a highly effective birth control method from the time
of the first dose of study drug through 45 days after last dose of study drug.

7. 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 study drug through 105
days after last dose of study drug. Contraception should be considered for a
nonpregnant female partner of childbearing potential.

8. Male and female patients must agree not to donate sperm or eggs, respectively, from
the first dose of study drug through 105 days and 45 days after the last dose of study
drug, respectively.

9. Female patients may not be breastfeeding at screening and must not breastfeed during
study participation through 45 days after the last dose of study drug.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. Use of antineoplastic therapies within 21 days before day 1.

2. Use of any other investigational agent within 21 days before day 1.

3. Have not recovered (recovery is defined as National Cancer Institute Common
Terminology Criteria for Adverse Events [CTCAE] grade ? 1) from the acute toxicities
of previous therapy, except treatment related alopecia or laboratory abnormalities
otherwise meeting eligibility requirements.

4. Electrolyte abnormality that has not responded to correction, including hypokalemia or
hypocalcemia less than the lower limit of normal, or hyperkalemia or hypercalcemia
greater than the upper limit of normal (ULN).

5. Major surgery within 14 days before day 1.

6. Diagnosis of myelodysplastic syndrome (MDS) or a hematologic malignancy.

7. Clinically significant cardiovascular disease.

8. Significant organ dysfunction.

9. Gastrointestinal disorder affecting absorption.

10. Current or anticipated use of a strong P-gp inhibitor, strong P-gp inducer, or strong
inhibitor of BCRP.

11. Any condition (concurrent disease, infection, or comorbidity) that interferes with
ability to participate in the study, causes undue risk, or complicates the
interpretation of safety data, in the opinion of the investigator or medical monitor.

NCT03042910
Pfizer
Completed
A Study to Assess the Effects of Talazoparib on Cardiac Repolarization in Patients With Advanced Solid Tumors

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Advanced Cancer, Advanced Solid Tumors
NCT00729833
All Genders
18+
Years
Multiple Sites
Well-differentiated Pancreatic Neuroendocrine Tumor
NCT01525550
All Genders
18+
Years
Multiple Sites
Unspecified Adult Solid Tumor, Chemotherapy, Liver Dysfunction, Solid Tumor Neoplasms
NCT00037804
All Genders
18+
Years
Multiple Sites
A Study to Assess the Effects of Talazoparib on Cardiac Repolarization in Patients With Advanced Solid Tumors
A Phase 1, Open-label Study To Assess The Effects Of Talazoparib On Cardiac Repolarization In Patients With Advanced Solid Tumors
This study is designed to evaluate the effects of talazoparib on cardiac repolarization in patients with advanced solid tumors with no available standard treatment options.
For further talazoparib treatment, patients must enroll and initiate continued talazoparib treatment in a separate open label extension study within 30 days after the last dose of study drug.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Solid Tumor
Drug: Talazoparib
Talazoparib 1 mg orally once daily.
Other Names:
  • MDV3800
  • BMN673
Experimental: Patients with advanced solid tumors
Talazoparib 1 mg daily
Intervention: Drug: Talazoparib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
June 22, 2017
May 30, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. At least 18 years of age and willing and able to provide informed consent.
  2. Histologically or cytologically confirmed advanced solid tumor with no available standard treatment options in the opinion of the investigator.
  3. Eastern Cooperative Oncology Group (ECOG) performance status ? 2.
  4. Estimated life expectancy of ? 3 months.
  5. Able to swallow the study drug, have no known intolerance to the study drug or excipients, and comply with study requirements.
  6. Female patients of childbearing potential must have a negative pregnancy test at screening and must agree to use a highly effective birth control method from the time of the first dose of study drug through 45 days after last dose of study drug.
  7. 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 study drug through 105 days after last dose of study drug. Contraception should be considered for a nonpregnant female partner of childbearing potential.
  8. Male and female patients must agree not to donate sperm or eggs, respectively, from the first dose of study drug through 105 days and 45 days after the last dose of study drug, respectively.
  9. Female patients may not be breastfeeding at screening and must not breastfeed during study participation through 45 days after the last dose of study drug.

Exclusion Criteria:

  1. Use of antineoplastic therapies within 21 days before day 1.
  2. Use of any other investigational agent within 21 days before day 1.
  3. Have not recovered (recovery is defined as National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE] grade ? 1) from the acute toxicities of previous therapy, except treatment related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.
  4. Electrolyte abnormality that has not responded to correction, including hypokalemia or hypocalcemia less than the lower limit of normal, or hyperkalemia or hypercalcemia greater than the upper limit of normal (ULN).
  5. Major surgery within 14 days before day 1.
  6. Diagnosis of myelodysplastic syndrome (MDS) or a hematologic malignancy.
  7. Clinically significant cardiovascular disease.
  8. Significant organ dysfunction.
  9. Gastrointestinal disorder affecting absorption.
  10. Current or anticipated use of a strong P-gp inhibitor, strong P-gp inducer, or strong inhibitor of BCRP.
  11. Any condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of safety data, in the opinion of the investigator or medical monitor.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT03042910
MDV3800-14
C3441005 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Medivation, Inc.
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now