PF-07104091 as a Single Agent and in Combination Therapy

NCT04553133

Last updated date
Study Location
START Midwest
Grand Rapids, Michigan, 49546, 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.
Small Cell Lung Cancer, Ovarian Cancer, Triple Negative Breast Cancer, Non-small Cell Lung Cancer, Human Receptor-positive Human Epidermal Growth Factor Receptor 2
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

- Participants with HR-positive HER2-negative advanced or metastatic breast cancer (received at least two prior lines in the advanced or metastatic setting including one prior line of combined CDK4/6 inhibitor and endocrine therapy and no more than two prior lines of cytotoxic chemotherapy)

- Participants with locally recurrent/advanced or metastatic TNBC who have received up to 2 prior lines of chemotherapy in the advanced or metastatic setting

- Participants with advanced platinum resistant epithelial ovarian cancer (EOC)/fallopian tube cancer/primary peritoneal cancer (PPC) (histologically or cytologically proven) who have received up to 3 prior lines of therapy

- Participants with cytological diagnosis of advanced/metastatic SCLC

- Participants with or cytological diagnosis of advanced/metastatic NSCLC

- Participants entering the study in the expansion cohort have at least one measurable lesion as defined by RECIST version 1.1 that has not been previously irradiated

- Performance Status 0 or 1

- Adequate bone marrow, hematological, kidney and liver function

- Resolved acute effects of any prior therapy to baseline severity

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


- Participants with known symptomatic brain metastases requiring steroids


- Participants with any other active malignancy within 3 years prior to enrollment


- Major surgery within 3 weeks prior to study entry


- Radiation therapy within 3 weeks prior to study entry.


- Systemic anti cancer therapy within 4 weeks prior to study


- Prior irradiation to >25% of the bone marrow


- Participants with active, uncontrolled bacterial, fungal, or viral infection,
including HBV, HCV, and known HIV or AIDS related illness


- COVID-19/SARS-CoV2


- Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may
affect participant safety or interpretation of study results


- Any of the following in the previous 6 months: myocardial infarction, long QT
syndrome, Torsade de Pointes, arrhythmias, serious conduction system abnormalities,
unstable angina, coronary/peripheral artery bypass graft, symptomatic CHF, New York
Heart Association class III or IV, cerebrovascular accident, transient ischemic
attack, symptomatic pulmonary embolism, and/or other clinical significant episode of
thrombo embolic disease.


- Anticoagulation with vitamin K antagonists or factor Xa inhibitors is not allowed.


- Hypertension that cannot be controlled by medications


- Participation in other studies involving investigational drug(s) within 2 weeks prior
to study entry.


- Known or suspected hypersensitivity to active ingredient/excipients in PF 07104091.


- Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular
disease or previous gastric resection or lap band surgery.


- Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk
of life threatening complications in the short


- Participants with an indwelling catheter that has an external component such as those
used for drainage of effusion(s) or central venous catheter that is externally


- Previous high dose chemotherapy requiring stem cell rescue


- Known abnormalities in coagulation such as bleeding diathesis, or treatment with
anticoagulants precluding intramuscular injections of goserelin (if applicable).


- Current use or anticipated need for food or drugs that are known strong CYP3A4/5 or
UGT1A9 inhibitors or inducers


- Current use or anticipated need for drugs that are known sensitive UGT1A1 substrates
with narrow therapeutic


- Serum pregnancy test positive at screening


- Other medical or psychiatric condition

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Small Cell Lung Cancer, Ovarian Cancer, Triple Negative Breast Cancer, Non-small Cell Lung Cancer, Human Receptor-positive Human Epidermal Growth Factor Receptor 2PF-07104091 as a Single Agent and in Combination Therapy
NCT04553133
  1. Grand Rapids, Michigan
  2. Houston, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE PF-07104091 as a Single Agent and in Combination Therapy
Official Title  ICMJE PHASE 1/2A DOSE ESCALATION, FINDING AND EXPANSION STUDY EVALUATING SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07104091 AS A SINGLE AGENT AND IN COMBINATION THERAPY
Brief Summary To assess the safety and tolerability of increasing doses of PF-07104091 and to estimate the Maximum Tolerated Dose (MTD) and/or select the Recommended Phase 2 dose (RP2D) for PF 07104091 as a single agent in participants with small cell lung, non small cell lung ovarian and breast cancers.
Detailed Description Study C4161001 is a Phase 1, open label, multi dose, multi center, dose escalation, safety, pharmacokinetic (PK) and pharmacodynamic study of PF-07104091 in adult patients with advanced or metastatic small cell lung cancer (SCLC), advanced platinum resistant epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer, locally recurrent/advanced or metastatic triple negative breast cancer (TNBC), HR-positive HER2-negative advanced or mBC, advanced or metastatic non-small cell lung cancer (NSCLC). This two part study will assess the safety and tolerability of increasing dose levels of PF-07104091 in Part 1, and establish the recommended Phase 2 dose (RP2D) in Part 2.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Small Cell Lung Cancer
  • Ovarian Cancer
  • Triple Negative Breast Cancer
  • Non-small Cell Lung Cancer
  • Human Receptor-positive Human Epidermal Growth Factor Receptor 2
Intervention  ICMJE
  • Drug: PF-07104091 monotherapy
    PF-07104091 will be administered orally
  • Drug: PF-07104091 + palbociclib
    PF-07104091 will be administered orally in combination with palbociclib
  • Drug: PF-07104091 + palbociclib + letrozole
    PF-07104091 will be administered orally in combination with palbociclib and letrozole
Study Arms  ICMJE
  • Experimental: PF-07104091
    CDK2 monotherapy
    Intervention: Drug: PF-07104091 monotherapy
  • Experimental: PF-07104091 + palbociclib
    CDK2 + palbociclib
    Intervention: Drug: PF-07104091 + palbociclib
  • Experimental: PF-07104091 + palbociclib + letrozole
    CDK2 + palbociclib + letrozole
    Intervention: Drug: PF-07104091 + palbociclib + letrozole
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 11, 2020)
144
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 18, 2025
Estimated Primary Completion Date April 18, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants with HR-positive HER2-negative advanced or metastatic breast cancer (received at least two prior lines in the advanced or metastatic setting including one prior line of combined CDK4/6 inhibitor and endocrine therapy and no more than two prior lines of cytotoxic chemotherapy)
  • Participants with locally recurrent/advanced or metastatic TNBC who have received up to 2 prior lines of chemotherapy in the advanced or metastatic setting
  • Participants with advanced platinum resistant epithelial ovarian cancer (EOC)/fallopian tube cancer/primary peritoneal cancer (PPC) (histologically or cytologically proven) who have received up to 3 prior lines of therapy
  • Participants with cytological diagnosis of advanced/metastatic SCLC
  • Participants with or cytological diagnosis of advanced/metastatic NSCLC
  • Participants entering the study in the expansion cohort have at least one measurable lesion as defined by RECIST version 1.1 that has not been previously irradiated
  • Performance Status 0 or 1
  • Adequate bone marrow, hematological, kidney and liver function
  • Resolved acute effects of any prior therapy to baseline severity

Exclusion Criteria:

  • Participants with known symptomatic brain metastases requiring steroids
  • Participants with any other active malignancy within 3 years prior to enrollment
  • Major surgery within 3 weeks prior to study entry
  • Radiation therapy within 3 weeks prior to study entry.
  • Systemic anti cancer therapy within 4 weeks prior to study
  • Prior irradiation to >25% of the bone marrow
  • Participants with active, uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, and known HIV or AIDS related illness
  • COVID-19/SARS-CoV2
  • Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
  • Any of the following in the previous 6 months: myocardial infarction, long QT syndrome, Torsade de Pointes, arrhythmias, serious conduction system abnormalities, unstable angina, coronary/peripheral artery bypass graft, symptomatic CHF, New York Heart Association class III or IV, cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, and/or other clinical significant episode of thrombo embolic disease.
  • Anticoagulation with vitamin K antagonists or factor Xa inhibitors is not allowed.
  • Hypertension that cannot be controlled by medications
  • Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry.
  • Known or suspected hypersensitivity to active ingredient/excipients in PF 07104091.
  • Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery.
  • Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk of life threatening complications in the short
  • Participants with an indwelling catheter that has an external component such as those used for drainage of effusion(s) or central venous catheter that is externally
  • Previous high dose chemotherapy requiring stem cell rescue
  • Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of goserelin (if applicable).
  • Current use or anticipated need for food or drugs that are known strong CYP3A4/5 or UGT1A9 inhibitors or inducers
  • Current use or anticipated need for drugs that are known sensitive UGT1A1 substrates with narrow therapeutic
  • Serum pregnancy test positive at screening
  • Other medical or psychiatric condition
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 NCT04553133
Other Study ID Numbers  ICMJE C4161001
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: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/d….
URL: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