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A Safety, Pharmacokinetic, Pharmacodynamic and Anti-Tumor Study of PF-06873600 as a Single Agent and in Combination With Endocrine Therapy

Last updated on December 4, 2019

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Study Location
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ovarian Cancer HR+ HER2- Metastatic Breast Cancer
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

- Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor
Receptor 2 Negative (HER2-) breast cancer

• Prior combined CDK 4/6 inhibitor and endocrine therapy and 1 or 2 prior lines of
chemotherapy

- Have a diagnosis of metastatic triple negative breast cancer (TNBC)

• Up to 1-2 prior lines of chemotherapy

- Have a diagnosis of advanced platinum resistant epithelial ovarian cancer
(EOC)/fallopian tube cancer/primary peritoneal cancer (PPC)

• Up to 2-3 prior lines of therapy

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1

- Measurable disease or non-measurable disease and refractory to or intolerant of
existing therapies (Part 1)

- Measurable disease as defined by RECIST 1.1 is required (Part 2)

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

- Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases

- Other active malignancy within 3 years prior to randomization, except for adequately
treated basal cell or squamous cell skin cancer, or carcinoma in situ

- Major surgery or radiation within 4 weeks prior to study entry

- Last anti-cancer treatment within 2 weeks prior to study entry

- Participation in other studies involving investigational drug(s) within 4 weeks prior
to study entry

- Pregnant or breastfeeding female patients

- Active inflammatory gastrointestinal (GI) disease, known diverticular disease or
previous gastric resection or lap band surgery including impairment of gastro
intestinal function or GI disease

NCT03519178
Pfizer
Recruiting
A Safety, Pharmacokinetic, Pharmacodynamic and Anti-Tumor Study of PF-06873600 as a Single Agent and in Combination With Endocrine Therapy

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Descriptive Information
Brief Title  ICMJE A Safety, Pharmacokinetic, Pharmacodynamic and Anti-Tumor Study of PF-06873600 as a Single Agent and in Combination With Endocrine Therapy
Official Title  ICMJE PHASE 1/2A DOSE ESCALATION AND EXPANSION STUDY EVALUATING SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMICS AND ANTI-TUMOR ACTIVITY OF PF-06873600 AS A SINGLE AGENT AND IN COMBINATION WITH ENDOCRINE THERAPY
Brief SummaryOpen-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06873600 administered as a single agent and then in combination with endocrine therapy. The study contains two parts, a Part 1 single agent dose escalation and combination endocrine therapy dose finding component and a Part 2 dose expansion as both a single agent and in combination with endocrine therapy.
Detailed DescriptionThis is a Phase 1/2a, open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study of PF-06873600 administered as a single agent in sequential dose levels and then in combination with endocrine therapy. In Part 1A, successive cohorts of patients will receive escalating doses of PF-06873600 and then in dose finding (Part 1B) with PF-06873600 in combination with endocrine therapy (ET). This study contains 2 parts, dose escalation with single agent (Part 1A) and then dose finding with PF-06873600 in combination with endocrine therapy (Part 1B) followed by dose expansion arms as a single agent and PF-06873600 in combination with endocrine therapy (Part 2).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HR+ HER2- Metastatic Breast Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Triple Negative Breast Cancer, Male Breast Cancer
Intervention  ICMJE
  • Drug: PF-06873600
    PF-06873600 tablet for oral dosing
  • Drug: Endocrine Therapy 1
    Endocrine Therapy 1
  • Drug: Endocrine Therapy 2
    Endocrine Therapy 2
Study Arms  ICMJE
  • Experimental: Dose Escalation
    Single Agent Dose Escalation
    Intervention: Drug: PF-06873600
  • Experimental: Dose Finding Endocrine Therapy 1 Combination
    Part 1B PF-06873600 plus Endocrine Therapy 1
    Interventions:
    • Drug: PF-06873600
    • Drug: Endocrine Therapy 1
  • Experimental: Dose Finding Endocrine Therapy 2 Combination
    Part 1B PF-06873600 plus Endocrine Therapy 2
    Interventions:
    • Drug: PF-06873600
    • Drug: Endocrine Therapy 2
  • Experimental: Dose Expansion Arm A
    PF-06873600 as a Single Agent
    Intervention: Drug: PF-06873600
  • Experimental: Dose Expansion Arm B
    PF-06873600 as a Single Agent in Various Tumor Types
    Intervention: Drug: PF-06873600
  • Experimental: Dose Expansion Arm C
    PF-06873600 in Combination with Endocrine Therapy 1
    Interventions:
    • Drug: PF-06873600
    • Drug: Endocrine Therapy 1
  • Experimental: Dose Expansion Arm D
    PF-06873600 in Combination with Endocrine Therapy 1
    Interventions:
    • Drug: PF-06873600
    • Drug: Endocrine Therapy 1
  • Experimental: Dose Expansion Arm E
    PF-06873600 in Combination with Endocrine Therapy 2
    Interventions:
    • Drug: PF-06873600
    • Drug: Endocrine Therapy 2
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 25, 2018)
220
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 19, 2023
Estimated Primary Completion DateMarch 19, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer

    ? Prior combined CDK 4/6 inhibitor and endocrine therapy and 1 or 2 prior lines of chemotherapy

  • Have a diagnosis of metastatic triple negative breast cancer (TNBC)

    ? Up to 1-2 prior lines of chemotherapy

  • Have a diagnosis of advanced platinum resistant epithelial ovarian cancer (EOC)/fallopian tube cancer/primary peritoneal cancer (PPC)

    ? Up to 2-3 prior lines of therapy

  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
  • Measurable disease or non-measurable disease and refractory to or intolerant of existing therapies (Part 1)
  • Measurable disease as defined by RECIST 1.1 is required (Part 2)

Exclusion Criteria:

  • Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases
  • Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
  • Major surgery or radiation within 4 weeks prior to study entry
  • Last anti-cancer treatment within 2 weeks prior to study entry
  • Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry
  • Pregnant or breastfeeding female patients
  • Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastro intestinal function or GI disease
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03519178
Other Study ID Numbers  ICMJE C3661001
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2019

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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