Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors

NCT04557449

Last updated date
Study Location
The University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Liposarcoma, CRC, Prostate Cancer, Breast Neoplasms, Adenocarcinoma of Lung, 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

- Disease Characteristics - Breast Cancer (Part 1A, Part 1B and Part 1C)

- Refractory Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer (2L + with prior CDK 4/6) locally advance or metastatic breast cancer. Participants should have received at least 1 line of SOC, including CDK4/6 inhibitor therapy, or at least 1 line of anti-endocrine therapy in countries without CDK4/6 inhibitor approval or reimbursement, for advanced or metastatic disease

- Part 1A only: Refractory HR-positive (HR+), Human Epidermal Growth Factor Receptor 2 Positive (HER2+) breast cancer

- Evaluable lesion (including skin or bone lesion only)

- Disease Characteristics - Part 1A: Tumors other than BC

- Participants with advanced or metastatic disease

- Participants with histological or cytological diagnosis of adenocarcinoma of NSCLC, prostate, CRC, liposarcoma, or tumors with previously confirmed CDK4 or CCND1 amplification according to local standard tests, that is resistant to at least 2 lines of standard systemic therapy for advanced or recurrent disease or for which no standard therapy is available

- Participants must not be eligible to undergo therapy with curative intent (surgery or radiation therapy with or without chemotherapy

General

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
carcinomatous meningitis, or leptomeningeal disease


- 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 intervention


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


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


- Pregnant or breastfeeding female participant


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

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Liposarcoma, CRC, Prostate Cancer, Breast Neoplasms, Adenocarcinoma of Lung, Solid TumorsStudy to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
NCT04557449
  1. Houston, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
Official Title  ICMJE A PHASE 1/1B STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-07220060 AS A SINGLE AGENT AND AS PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
Brief Summary

This is a Phase 1, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-07220060 administered as a single agent and then in combination with endocrine therapy.

In Part 1A, single escalating doses of PF-07220060 alone will be administered to determine the maximum tolerated dose (MTD) and select the recommended phase 2 dose (RP2D). In Part 1B and Part 1C, PF-07220060 will be administered in combination with 1 of 2 endocrine therapies (letrozole and fulvestrant, respectively).

Part 1B and Part 1C may be enrolled and conducted in parallel at the completion of Part 1A.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Liposarcoma
  • CRC
  • Prostate Cancer
  • Breast Neoplasms
  • Adenocarcinoma of Lung
  • Solid Tumors
Intervention  ICMJE
  • Drug: PF-07220060
    CDK4 inhibitor
  • Combination Product: Letrozole
    Endocrine Therapy
    Other Name: Femara
  • Combination Product: Fulvestrant
    Endocrine Therapy
    Other Name: Faslodex
Study Arms  ICMJE
  • Experimental: Monotherapy Escalation Arm 1
    PF-07220060 Monotherapy Escalation
    Intervention: Drug: PF-07220060
  • Experimental: Monotherapy Escalation Arm 2
    PF-07220060 Monotherapy Escalation
    Intervention: Drug: PF-07220060
  • Experimental: Monotherapy Escalation Arm 3
    PF-07220060 Monotherapy Escalation
    Intervention: Drug: PF-07220060
  • Experimental: Monotherapy Escalation Arm 4
    PF-07220060 Monotherapy Escalation
    Intervention: Drug: PF-07220060
  • Experimental: 1B Combination Dose Finding Arm 1
    PF-07220060 with Letrozole combination Escalation
    Interventions:
    • Drug: PF-07220060
    • Combination Product: Letrozole
  • Experimental: 1B Combination Dose Finding Arm 2
    PF-07220060 with Letrozole Combination Escalation
    Interventions:
    • Drug: PF-07220060
    • Combination Product: Letrozole
  • Experimental: 1C Combination Dose Finding Arm 1
    PF-07220060 with Fulvestrant Combination Escalation
    Interventions:
    • Drug: PF-07220060
    • Combination Product: Fulvestrant
  • Experimental: 1C Combination Dose Finding Arm 2
    PF-07220060 with Fulvestrant Combination Escalation
    Interventions:
    • Drug: PF-07220060
    • Combination Product: Fulvestrant
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 15, 2020)
52
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 4, 2024
Estimated Primary Completion Date September 4, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Disease Characteristics - Breast Cancer (Part 1A, Part 1B and Part 1C)
  • Refractory Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer (2L + with prior CDK 4/6) locally advance or metastatic breast cancer. Participants should have received at least 1 line of SOC, including CDK4/6 inhibitor therapy, or at least 1 line of anti-endocrine therapy in countries without CDK4/6 inhibitor approval or reimbursement, for advanced or metastatic disease
  • Part 1A only: Refractory HR-positive (HR+), Human Epidermal Growth Factor Receptor 2 Positive (HER2+) breast cancer
  • Evaluable lesion (including skin or bone lesion only)
  • Disease Characteristics - Part 1A: Tumors other than BC
  • Participants with advanced or metastatic disease
  • Participants with histological or cytological diagnosis of adenocarcinoma of NSCLC, prostate, CRC, liposarcoma, or tumors with previously confirmed CDK4 or CCND1 amplification according to local standard tests, that is resistant to at least 2 lines of standard systemic therapy for advanced or recurrent disease or for which no standard therapy is available
  • Participants must not be eligible to undergo therapy with curative intent (surgery or radiation therapy with or without chemotherapy

General Inclusion Criteria

  • All participants must be refractory to or intolerant of existing therapies known to provide clinical benefit for their condition.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
  • Adequate renal, liver, and bone marrow function

Exclusion Criteria:

  • Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases carcinomatous meningitis, or leptomeningeal disease
  • 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 intervention
  • Last anti-cancer treatment within 2 weeks prior to study intervention
  • Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry
  • Pregnant or breastfeeding female participant
  • Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastrointestinal 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 NCT04557449
Other Study ID Numbers  ICMJE C4391001
2020-002938-33 ( EudraCT Number )
Has Data Monitoring Committee No
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:No
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/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP