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A Study to Evaluate the Effect of Itraconazole and Rifampin on the Pharmacokinetics of Talazoparib in Patients With Advanced Solid Tumors

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
PRA Magyarorszag Kft, Fazis I-es Klinikai Farmakologiai Vizsgalohely
Budapest, , 1077 Hungary
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Solid Tumors
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. Arm A: At least 18 years of age and and willing and able to provide informed consent. Arm B: At least 18 years of age (at
the time point of consent) and willing and able to provide informed consent.

2. Histologically confirmed advanced solid tumor (limited to platinum-resistant ovarian
carcinoma, cervical adenocarcinoma, small cell lung carcinoma or triple-negative
breast cancer) judged by the Investigator to not be appropriate for standard therapy.

3. ECOG performance status ≤ 2 at screening and at time of enrollment.

4. Expected life expectancy of ≥ 3 months.

5. Able to swallow the study drug and comply with study requirements.

6. Female subjects may be enrolled if they are considered not of childbearing potential,
or who are post-menopausal, or are of childbearing potential using a highly effective
form of contraceptive, and female subjects should not donate eggs from the time point
of investigational medicinal product (IMP) administration until at least 45 days
thereafter.

7. Males with partners of childbearing potential may be enrolled if they use a condom
when having sex with a pregnant woman or with a woman of childbearing potential, and
do not donate sperm from the time point of study drug administration until at least
105 days thereafter, and males should not donate sperm from the time point of study
drug administration until at least 105 days thereafter.

8. Female subjects must not be breastfeeding at screening and during the study
participation until 45 days after the last dose of the study drug.

9. Willingness and ability to comply with scheduled visits, treatment plan, laboratory
tests, and other trial procedures.

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

1. Treatment within 14 days or 5 half lives prior to dosing with any type of systemic
anticancer therapy or any investigational agent, whichever is longer

2. Major surgery within 8 weeks before screening.

3. Serious accompanying disorder or impaired organ function.

4. Symptomatic or impending spinal cord compression or cauda equina syndrome.

5. Non-healing wound, ulcer, or bone fracture, not including a pathological bone fracture
caused by a pre-existent pathological bone lesion.

6. Known myelodysplastic syndrome.

7. Subjects with the following serologies should be excluded: HBsAg+ or anti-HBc+;HCV+;
HIV+.

8. Serious or unstable medical condition that interferes with ability to tolerate
treatment or assessments associated with the protocol.

9. Gastrointestinal disorder affecting absorption.

10. Known hypersensitivity to any of the talazoparib capsule components.

11. Any condition or reason 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 Sponsor (e.g. non-compliance, excessive alcohol consumption,
intake of drugs of abuse unless these drugs are medically indicated [e.g. opiates for
pain relief].

NCT03077607
Pfizer
Recruiting
A Study to Evaluate the Effect of Itraconazole and Rifampin on the Pharmacokinetics of Talazoparib in Patients With Advanced Solid Tumors

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A Study to Evaluate the Effect of Itraconazole and Rifampin on the Pharmacokinetics of Talazoparib in Patients With Advanced Solid Tumors
A Phase 1 Open-label, Two-arm,Drug-drug Interaction Study To Evaluate The Effect Of Itraconazole And Rifampin On The Pharmacokinetics Of Talazoparib In Patients With Advanced Solid Tumors
This is a study in patients with advanced solid tumors for the investigation of P-gp inhibition and induction on the PK of talazoparib.
Subjects participating in this study with no clinically significant toxicities and no disease progression may be eligible to continue treatment on a separate extension protocol (MDV3800-13).
Interventional
Phase 1
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Solid Tumors
  • Drug: Talazoparib
    Arm A: 0.5 mg oral dose Arm B: 1 mg oral dose
  • Drug: Itraconazole
    100 mg oral dose
  • Drug: Rifampin
    600 mg oral dose
  • Experimental: Arm A
    Subjects will receive a 0.5 mg talazoparib and 100 mg itraconazole.
    Interventions:
    • Drug: Talazoparib
    • Drug: Itraconazole
  • Experimental: Arm B
    Subjects will receive 1 mg talazoparib and 600 mg rifampin.
    Interventions:
    • Drug: Talazoparib
    • Drug: Rifampin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
January 9, 2018
January 9, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Arm A: At least 18 years of age and <65 years of age (at the time point of consent) and willing and able to provide informed consent. Arm B: At least 18 years of age (at the time point of consent) and willing and able to provide informed consent.
  2. Histologically confirmed advanced solid tumor (limited to platinum-resistant ovarian carcinoma, cervical adenocarcinoma, small cell lung carcinoma or triple-negative breast cancer) judged by the Investigator to not be appropriate for standard therapy.
  3. ECOG performance status ? 2 at screening and at time of enrollment.
  4. Expected life expectancy of ? 3 months.
  5. Able to swallow the study drug and comply with study requirements.
  6. Female subjects may be enrolled if they are considered not of childbearing potential, or who are post-menopausal, or are of childbearing potential using a highly effective form of contraceptive, and female subjects should not donate eggs from the time point of investigational medicinal product (IMP) administration until at least 45 days thereafter.
  7. Males with partners of childbearing potential may be enrolled if they use a condom when having sex with a pregnant woman or with a woman of childbearing potential, and do not donate sperm from the time point of study drug administration until at least 105 days thereafter, and males should not donate sperm from the time point of study drug administration until at least 105 days thereafter.
  8. Female subjects must not be breastfeeding at screening and during the study participation until 45 days after the last dose of the study drug.
  9. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.

Exclusion Criteria:

  1. Treatment within 14 days or 5 half lives prior to dosing with any type of systemic anticancer therapy or any investigational agent, whichever is longer
  2. Major surgery within 8 weeks before screening.
  3. Serious accompanying disorder or impaired organ function.
  4. Symptomatic or impending spinal cord compression or cauda equina syndrome.
  5. Non-healing wound, ulcer, or bone fracture, not including a pathological bone fracture caused by a pre-existent pathological bone lesion.
  6. Known myelodysplastic syndrome.
  7. Subjects with the following serologies should be excluded: HBsAg+ or anti-HBc+;HCV+; HIV+.
  8. Serious or unstable medical condition that interferes with ability to tolerate treatment or assessments associated with the protocol.
  9. Gastrointestinal disorder affecting absorption.
  10. Known hypersensitivity to any of the talazoparib capsule components.
  11. Any condition or reason 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 Sponsor (e.g. non-compliance, excessive alcohol consumption, intake of drugs of abuse unless these drugs are medically indicated [e.g. opiates for pain relief].
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Hungary,   Moldova, Republic of,   Poland,   Russian Federation
 
 
NCT03077607
MDV3800-04
C3441004 ( Other Identifier: Alias Study Number )
2016-001813-26 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Medivation, Inc.
Study Director: Pfizer Pfizer CT.gov Call Center Pfizer
Pfizer
December 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.

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1-800-718-1021

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