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Trial record 41 of 205 for:    SPORANOX I.V. OR ITRACONAZOLE OR ONMEL OR SPORANOX-PULSE OR Sporanos OR R 51,211 OR SPORANOX

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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ClinicalTrials.gov Identifier: NCT03077607
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : November 8, 2018
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This is a study in patients with advanced solid tumors for the investigation of P-gp inhibition and induction on the PK of talazoparib.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: Talazoparib Drug: Itraconazole Drug: Rifampin Phase 1

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 7, 2016
Actual Primary Completion Date : December 19, 2017
Actual Study Completion Date : December 19, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A
Subjects will receive a 0.5 mg talazoparib and 100 mg itraconazole.
Drug: Talazoparib
Arm A: 0.5 mg oral dose Arm B: 1 mg oral dose

Drug: Itraconazole
100 mg oral dose

Experimental: Arm B
Subjects will receive 1 mg talazoparib and 600 mg rifampin.
Drug: Talazoparib
Arm A: 0.5 mg oral dose Arm B: 1 mg oral dose

Drug: Rifampin
600 mg oral dose




Primary Outcome Measures :
  1. Effect of itraconozole and rifampin on PK of talazoparib measured as point estimate (ratio of test to reference) and 90% of Cmax [ Time Frame: Approximately 8 months following first patient enrolled ]
  2. Effect of itraconozole and rifampin on PK of talazoparib measured as point estimate (ratio of test to reference) and 90% of AUCs [ Time Frame: Approximately 8 months following first patient enrolled ]

Secondary Outcome Measures :
  1. Safety and tolerability measured as summary of AEs [ Time Frame: Approximately 8 months following first patient enrolled ]
  2. Safety and tolerability measured by physical examinations [ Time Frame: Approximately 8 months following first patient enrolled ]
  3. Safety and tolerability measured by vital signs [ Time Frame: Approximately 8 months following first patient enrolled ]
  4. Safety and tolerability measured by electrocardiograms (ECGs) [ Time Frame: Approximately 8 months following first patient enrolled ]
  5. Safety and tolerability measured by laboratory evaluations [ Time Frame: Approximately 8 months following first patient enrolled ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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].

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077607


Locations
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Hungary
PRA Magyarorszag Kft, Fazis I-es Klinikai Farmakologiai Vizsgalohely
Budapest, Hungary, 1077
Moldova, Republic of
ARENSIA Exploratory Medicine Phase I Unit, PMSI Institute of Oncology
Chisinau, Moldova, Republic of, MD2025
Poland
Szpital LUX MED
Warsaw, Poland, 02-801
Russian Federation
I.M. Sechenov First Moscow State Medical University
Moscow, Russian Federation, 119435
I.M. Sechenov First Moscow State Medical University
Moscow, Russian Federation, 119991
"BioEq" LLC
Saint-Petersburg, Russian Federation, 197342
State budget healthcare institution of Yaroslavl region "Regional clinical oncology hospital"
Yaroslavl, Russian Federation, 150054
Sponsors and Collaborators
Pfizer
Medivation, Inc.
Investigators
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Study Director: Pfizer Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03077607     History of Changes
Other Study ID Numbers: MDV3800-04
C3441004 ( Other Identifier: Alias Study Number )
2016-001813-26 ( EudraCT Number )
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
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Itraconazole
Hydroxyitraconazole
Rifampin
Talazoparib
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
Poly(ADP-ribose) Polymerase Inhibitors
Antineoplastic Agents