Breast CancerPhase 1NCT05905341
Study of PF-07224826, as a Single Agent or in Combination With Endocrine Therapy in Participants With Breast Cancer and Other Advanced Solid Tumors.
A Phase 1 study testing PF-07224826 and Fulvestrant in people with Breast Cancer and Ovarian Cancer, run by Pfizer.
Trial summary
This is a Phase 1, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of PF-07224826, as a single agent or in combination with endocrine therapy in participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Ovarian Cancer, Liposarcoma
- What is being tested?
- PF-07224826 and Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2024to 13 Apr 2028
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Part 1:
- Participants with HR-positive HER2-negative locally advanced or metastatic breast cancer.
- Participants with locally recurrent/advanced or metastatic TNBC.
- Participants with advanced platinum resistant epithelial ovarian cancer (EOC)/fallopian tube cancer/primary peritoneal cancer (PPC).
- Other advanced solid tumor types: Tumors other than BC or Ovarian: NSCLC, prostate, endometrial, liposarcoma, or other tumors with cyclin D (CCND) and cyclin E (CCNE) implicated in pathogenesis either by gene amplification or overexpression.
- Part 2 (Arm A): Participants with HR positive HER2 negative locally advanced or mBC (post CDK4/6 inhibitors).
Show all 9Show fewer
- Part 2 (Arm B): Participants with HR positive HER2 negative locally advanced or mBC (naïve to CDK4/6 inhibitors).
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
- Adequate Bone Marrow Function
Who cannot join
- Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, Cerebral edema, and/or progressive growth. Participants with a history of CNS metastases or cord compression are eligible if they have been definitively treated (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before enrollment and have no evidence of progression at time of study enrollment.
- Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (eg, including participants with massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement).
- Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
- Last anticancer treatment within 2 weeks (or 5 half-lives, whichever is shorter), unless the last immediate anticancer treatment contained an antibody-based agent(s) (approved or investigational), then the interval of 4 weeks or 5 half-lives (whichever is shorter) is required prior to receiving the study intervention.
About this study
Official title: A PHASE 1, OPEN-LABEL, MULTICENTER, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTITUMOR ACTIVITY OF PF-07224826, AS A SINGLE AGENT AND IN COMBINATION WITH ENDOCRINE THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
This is a Phase 1, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of PF-07224826, as a single agent or in combination with endocrine therapy in participants with advanced solid tumors. This study will be divided into dose escalation/finding (Part 1) and dose expansion (Part 2).
In Part 1, participants with locally recurrent/advanced or metastatic Triple Negative Breast Cancer (TNBC), platinum resistant ovarian cancer and other advanced solid tumors will receive PF-07224826 as a single agent. Participants with HR-positive HER2-negative advanced or mBC will receive PF-07224826 in combination with endocrine therapy.
In Part 2 (Arm A), PF-07224826 will be evaluated in combination with fulvestrant in HR-positive HER2-negative advanced or mBC participants who have received prior CDK4/6 inhibitor. In Part 2 (Arm B), PF-07224826 will be evaluated in combination with fulvestrant in HR-positive HER2-negative locally advanced or mBC participants whose disease has progressed on prior endocrine therapy and is naïve to CDK4/6 inhibitors.
- Conditions
- Breast Cancer, Ovarian Cancer, Liposarcoma, Non-small Cell Lung Cancer (NSCLC), Endometrial, Solid Tumors
- Being tested
- PF-07224826, Fulvestrant
- Keywords
- cyclin-dependent kinase 2 (CDK2), cyclin-dependent kinase 4 (CDK4), cyclin-dependent kinase 6 (CDK6), hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-)
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Liposarcoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07224826Drug
Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally.
FulvestrantCombination product
Competitive ER antagonist, to be administered by intramuscular injection (prefilled syringe).
PF-07224826Drug
Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally.
FulvestrantCombination product
Competitive ER antagonist, to be administered by intramuscular injection (prefilled syringe).
PF-07224826Drug
Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally.
FulvestrantCombination product
Competitive ER antagonist, to be administered by intramuscular injection (prefilled syringe).
PF-07224826Drug
Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally.
FulvestrantCombination product
Competitive ER antagonist, to be administered by intramuscular injection (prefilled syringe).
PF-07224826Drug
Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally.
FulvestrantCombination product
Competitive ER antagonist, to be administered by intramuscular injection (prefilled syringe).
PF-07224826Drug
Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally.
FulvestrantCombination product
Competitive ER antagonist, to be administered by intramuscular injection (prefilled syringe).
PF-07224826Drug
Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally.
FulvestrantCombination product
Competitive ER antagonist, to be administered by intramuscular injection (prefilled syringe).
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Dose Escalation-Dose Level 1 | Experimental | In Part 1, participants with locally recurrent/advanced or metastatic TNBC, platinum resistant ovarian cancer and other advanced solid tumors will receive PF-07224826 as a single agent. Participants with HR-positive HER2-negative advanced or mBC will receive PF-07224826 in combination with endocrine therapy. PF-07224826 will be administered orally, once daily, on a continuous basis. Receives: Drug: PF-07224826; Combination Product: Fulvestrant |
| Part 1 Dose Escalation-Dose Level 2 | Experimental | In Part 1, participants with locally recurrent/advanced or metastatic TNBC, platinum resistant ovarian cancer and other advanced solid tumors will receive PF-07224826 as a single agent. Participants with HR-positive HER2-negative advanced or mBC will receive PF-07224826 in combination with endocrine therapy. PF-07224826 will be administered orally, once daily, on a continuous basis. Receives: Drug: PF-07224826; Combination Product: Fulvestrant |
| Part 1 Dose Escalation-Dose Level 3 | Experimental | In Part 1, participants with locally recurrent/advanced or metastatic TNBC, platinum resistant ovarian cancer and other advanced solid tumors will receive PF-07224826 as a single agent. Participants with HR-positive HER2-negative advanced or mBC will receive PF-07224826 in combination with endocrine therapy. PF-07224826 will be administered orally, once daily, on a continuous basis. Receives: Drug: PF-07224826; Combination Product: Fulvestrant |
| Part 1 Dose Escalation-Dose Level 4 | Experimental | In Part 1, participants with locally recurrent/advanced or metastatic TNBC, platinum resistant ovarian cancer and other advanced solid tumors will receive PF-07224826 as a single agent. Participants with HR-positive HER2-negative advanced or mBC will receive PF-07224826 in combination with endocrine therapy. PF-07224826 will be administered orally, once daily, on a continuous basis. Receives: Drug: PF-07224826; Combination Product: Fulvestrant |
| Part 1 Dose Escalation-Dose Level 5 | Experimental | In Part 1, participants with locally recurrent/advanced or metastatic TNBC, platinum resistant ovarian cancer and other advanced solid tumors will receive PF-07224826 as a single agent. Participants with HR-positive HER2-negative advanced or mBC will receive PF-07224826 in combination with endocrine therapy. PF-07224826 will be administered orally, once daily, on a continuous basis. Receives: Drug: PF-07224826; Combination Product: Fulvestrant |
| Part 2 - Arm A | Experimental | In Part 2 Arm A, PF-07224826 will be evaluated in combination with fulvestrant in HR positive HER2 negative advanced or mBC participants who have received prior CDK4/6 inhibitor. PF-07224826 will be administered orally, once daily, on a continuous basis. Receives: Drug: PF-07224826; Combination Product: Fulvestrant |
| Part 2 - Arm B | Experimental | In Part 2 Arm B, PF-07224826 will be evaluated in combination with fulvestrant in HR-positive HER2-negative locally advanced or mBC participants whose disease has progressed on prior endocrine therapy and is naïve to CDK4/6 inhibitors. PF-07224826 will be administered orally, once daily, on a continuous basis. Receives: Drug: PF-07224826; Combination Product: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: First cycle dose limiting toxicities (DLTs)
Measured: Cycle 1 (28 days)
Part 1 and Part 2: Adverse events (AEs) as characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 5.0), timing, seriousness and relationship to study therapy.
Measured: From the first dose to earliest of 28 days post last dosing date or day of new anticancer therapy -1 day.
Part 1 and Part 2: Number of participants with Clinical Laboratory abnormalities
Measured: From the first dose to earliest of 28 days post last dosing date or day of new anticancer therapy -1 day.
Part 1 and Part 2: Incidence of clinically significant abnormal vital signs.
Measured: From the first dose to earliest of 28 days post last dosing date or day of new anticancer therapy -1 day.
Part 2: Preliminary antitumor activity measure for efficacy includes ORR, as assessed using RECIST version 1.1.
Measured: From baseline until the date of first documented progression, or date of death of any cause, or date of withdrawal of consent, or date of lost to follow-up, whichever came first.
Part 1 and Part 2: Incidence of clinically significant abnormal ECGs.
Measured: From the first dose to earliest of 28 days post last dosing date or day of new anticancer therapy -1 day.
Secondary outcomes (15)
Part1 and Part 2: Maximum Observed Plasma Concentration (Cmax); Single Dose (SD)
Measured: Cycle 1 (Pre-dose, Day 1, 8, and 15) and Cycle 2 (Day 1). Each cycle is 28 days.
Part 1 and Part 2: Time to Reach Maximum Observed Plasma Concentration (Tmax); Single Dose (SD)
Measured: Cycle 1 (Pre-dose, Day 1, 8, and 15) and Cycle 2 (Day 1). Each cycle is 28 days.
Part 1: Area under the concentration-time curve from 0 to time of last measurable concentration (AUClast)
Measured: Cycle 1 (Pre-dose, Day 1, 8, and 15) and Cycle 2 (Day 1). Each cycle is 28 days.
Part 1 and Part 2: Maximum Observed Plasma concentration (Cmax,ss), steady state
Measured: Cycle 1 (Pre-dose, Day 1, 8, and 15) and Cycle 2 (Day 1). Each cycle is 28 days.
Part 1 and Part 2: Time to Reach Maximum Observed Plasma Concentration steady state (Tmax, ss)
Measured: Cycle 1 (Pre-dose, Day 1, 8, and 15) and Cycle 2 (Day 1). Each cycle is 28 days.
Part 1 and Part 2: Minimum Observed Plasma Concentration (Cmin, ss), steady state
Measured: Cycle 1 (Pre-dose, Day 1, 8, and 15) and Cycle 2 (Day 1). Each cycle is 28 days.
Part 1: Area Under the concentration-time curve from 0 to time the end of the dosing interval (AUCtau,ss), steady state
Measured: Cycle 1 (Pre-dose, Day 1, 8, and 15) and Cycle 2 (Day 1). Each cycle is 28 days.
Part 2: Accumulation ratio (Rac)
Measured: Cycle 1 (Pre-dose, Day 1, 8, and 15) and Cycle 2 (Day 1). Each cycle is 28 days.
Part 1: Objective Response, as assessed using RECIST version 1.1.
Measured: From baseline and up to approximately 24 months
Part 1 and Part 2: Duration of Response (DoR) of PF-07224826 alone or in combination with fulvestrant
Measured: From baseline and up to approximately 24 months
Part 1 and Part 2: Progression-Free Survival (PFS) of PF-07224826 alone or in combination with fulvestrant
Measured: From baseline and up to approximately 24 months
Part 1 and Part 2: Time to Response (TTR) of PF-07224826 alone or in combination with fulvestrant
Measured: From baseline and up to approximately 24 months
Part 2: Overall Survival (OS) of PF-07224826 with fulvestrant
Measured: From baseline and up to approximately 24 months
Part 2: Clinical benefit response (CBR) of PF-07224826 with fulvestrant
Measured: From baseline and up to approximately 24 months
Part 1 and Part 2: Expression of Pharmacodynamic (PD) biomarkers in tumor tissue
Measured: From baseline and up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start15 Jan 2024 (estimated)
- Primary completion14 Apr 2026 (estimated)
- Study completion13 Apr 2028 (estimated)
Why it stopped: This decision was based on business considerations and not due to specific safety reasons or a request from a regulatory authority.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905341
- Sponsor's protocol ID
- C5331001
- Status last verified
- Nov 2023
- First submitted
- 24 May 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, MULTICENTER, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTITUMOR ACTIVITY OF PF-07224826, AS A SINGLE AGENT AND IN COMBINATION WITH ENDOCRINE THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
- ClinicalTrials.gov ID
- NCT05905341
- Acronym / sponsor ID
- C5331001
- Conditions
- Breast Cancer, Ovarian Cancer, Liposarcoma, Non-small Cell Lung Cancer (NSCLC), Endometrial, Solid Tumors
- Keywords
- cyclin-dependent kinase 2 (CDK2), cyclin-dependent kinase 4 (CDK4), cyclin-dependent kinase 6 (CDK6), hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This decision was based on business considerations and not due to specific safety reasons or a request from a regulatory authority.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 14 Apr 2026 (estimated)
- Study completion
- 13 Apr 2028 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of PF-07224826, as a single agent or in combination with endocrine therapy in participants with advanced solid tumors. This study will be divided into dose escalation/finding (Part 1) and dose expansion (Part 2).
In Part 1, participants with locally recurrent/advanced or metastatic Triple Negative Breast Cancer (TNBC), platinum resistant ovarian cancer and other advanced solid tumors will receive PF-07224826 as a single agent. Participants with HR-positive HER2-negative advanced or mBC will receive PF-07224826 in combination with endocrine therapy.
In Part 2 (Arm A), PF-07224826 will be evaluated in combination with fulvestrant in HR-positive HER2-negative advanced or mBC participants who have received prior CDK4/6 inhibitor. In Part 2 (Arm B), PF-07224826 will be evaluated in combination with fulvestrant in HR-positive HER2-negative locally advanced or mBC participants whose disease has progressed on prior endocrine therapy and is naïve to CDK4/6 inhibitors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part 1 Dose Escalation-Dose Level 1 | Experimental | Drug: PF-07224826, Combination Product: FulvestrantIn Part 1, participants with locally recurrent/advanced or metastatic TNBC, platinum resistant ovarian cancer and other advanced solid tumors will receive PF-07224826 as a single agent. Participants with HR-positive HER2-negative advanced or mBC will receive PF-07224826 in combination with endocrine therapy. PF-07224826 will be administered orally, once daily, on a continuous basis. |
| Part 1 Dose Escalation-Dose Level 2 | Experimental | Drug: PF-07224826, Combination Product: FulvestrantIn Part 1, participants with locally recurrent/advanced or metastatic TNBC, platinum resistant ovarian cancer and other advanced solid tumors will receive PF-07224826 as a single agent. Participants with HR-positive HER2-negative advanced or mBC will receive PF-07224826 in combination with endocrine therapy. PF-07224826 will be administered orally, once daily, on a continuous basis. |
| Part 1 Dose Escalation-Dose Level 3 | Experimental | Drug: PF-07224826, Combination Product: FulvestrantIn Part 1, participants with locally recurrent/advanced or metastatic TNBC, platinum resistant ovarian cancer and other advanced solid tumors will receive PF-07224826 as a single agent. Participants with HR-positive HER2-negative advanced or mBC will receive PF-07224826 in combination with endocrine therapy. PF-07224826 will be administered orally, once daily, on a continuous basis. |
| Part 1 Dose Escalation-Dose Level 4 | Experimental | Drug: PF-07224826, Combination Product: FulvestrantIn Part 1, participants with locally recurrent/advanced or metastatic TNBC, platinum resistant ovarian cancer and other advanced solid tumors will receive PF-07224826 as a single agent. Participants with HR-positive HER2-negative advanced or mBC will receive PF-07224826 in combination with endocrine therapy. PF-07224826 will be administered orally, once daily, on a continuous basis. |
| Part 1 Dose Escalation-Dose Level 5 | Experimental | Drug: PF-07224826, Combination Product: FulvestrantIn Part 1, participants with locally recurrent/advanced or metastatic TNBC, platinum resistant ovarian cancer and other advanced solid tumors will receive PF-07224826 as a single agent. Participants with HR-positive HER2-negative advanced or mBC will receive PF-07224826 in combination with endocrine therapy. PF-07224826 will be administered orally, once daily, on a continuous basis. |
| Part 2 - Arm A | Experimental | Drug: PF-07224826, Combination Product: FulvestrantIn Part 2 Arm A, PF-07224826 will be evaluated in combination with fulvestrant in HR positive HER2 negative advanced or mBC participants who have received prior CDK4/6 inhibitor. PF-07224826 will be administered orally, once daily, on a continuous basis. |
| Part 2 - Arm B | Experimental | Drug: PF-07224826, Combination Product: FulvestrantIn Part 2 Arm B, PF-07224826 will be evaluated in combination with fulvestrant in HR-positive HER2-negative locally advanced or mBC participants whose disease has progressed on prior endocrine therapy and is naïve to CDK4/6 inhibitors. PF-07224826 will be administered orally, once daily, on a continuous basis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Part 1:
- Part 2 (Arm A): Participants with HR positive HER2 negative locally advanced or mBC (post CDK4/6 inhibitors).
- Part 2 (Arm B): Participants with HR positive HER2 negative locally advanced or mBC (naïve to CDK4/6 inhibitors).
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
- Adequate Bone Marrow Function
Key exclusion criteria (4 listed)
- Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, Cerebral edema, and/or progressive growth. Participants with a history of CNS metastases or cord compression are eligible if they have been definitively treated (eg, radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4 weeks before enrollment and have no evidence of progression at time of study enrollment.
- Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (eg, including participants with massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement).
- Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
- Last anticancer treatment within 2 weeks (or 5 half-lives, whichever is shorter), unless the last immediate anticancer treatment contained an antibody-based agent(s) (approved or investigational), then the interval of 4 weeks or 5 half-lives (whichever is shorter) is required prior to receiving the study intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-07224826Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally. | Drug | Part 1 Dose Escalation-Dose Level 1 |
| FulvestrantCompetitive ER antagonist, to be administered by intramuscular injection (prefilled syringe). | Combination product | Part 1 Dose Escalation-Dose Level 1 |
| PF-07224826Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally. | Drug | Part 1 Dose Escalation-Dose Level 2 |
| FulvestrantCompetitive ER antagonist, to be administered by intramuscular injection (prefilled syringe). | Combination product | Part 1 Dose Escalation-Dose Level 2 |
| PF-07224826Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally. | Drug | Part 1 Dose Escalation-Dose Level 3 |
| FulvestrantCompetitive ER antagonist, to be administered by intramuscular injection (prefilled syringe). | Combination product | Part 1 Dose Escalation-Dose Level 3 |
| PF-07224826Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally. | Drug | Part 1 Dose Escalation-Dose Level 4 |
| FulvestrantCompetitive ER antagonist, to be administered by intramuscular injection (prefilled syringe). | Combination product | Part 1 Dose Escalation-Dose Level 4 |
| PF-07224826Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally. | Drug | Part 1 Dose Escalation-Dose Level 5 |
| FulvestrantCompetitive ER antagonist, to be administered by intramuscular injection (prefilled syringe). | Combination product | Part 1 Dose Escalation-Dose Level 5 |
| PF-07224826Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally. | Drug | Part 2 - Arm A |
| FulvestrantCompetitive ER antagonist, to be administered by intramuscular injection (prefilled syringe). | Combination product | Part 2 - Arm A |
| PF-07224826Small molecule cell cycle checkpoint inhibitor that targets CDK 2, 4, and 6, to be administered orally. | Drug | Part 2 - Arm B |
| FulvestrantCompetitive ER antagonist, to be administered by intramuscular injection (prefilled syringe). | Combination product | Part 2 - Arm B |
Primary outcome
Part 1: First cycle dose limiting toxicities (DLTs)
Time frame: Cycle 1 (28 days)
Part 1 and Part 2: Adverse events (AEs) as characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 5.0), timing, seriousness and relationship to study therapy.
Time frame: From the first dose to earliest of 28 days post last dosing date or day of new anticancer therapy -1 day.
Part 1 and Part 2: Number of participants with Clinical Laboratory abnormalities
Time frame: From the first dose to earliest of 28 days post last dosing date or day of new anticancer therapy -1 day.
Part 1 and Part 2: Incidence of clinically significant abnormal vital signs.
Time frame: From the first dose to earliest of 28 days post last dosing date or day of new anticancer therapy -1 day.
Part 2: Preliminary antitumor activity measure for efficacy includes ORR, as assessed using RECIST version 1.1.
Time frame: From baseline until the date of first documented progression, or date of death of any cause, or date of withdrawal of consent, or date of lost to follow-up, whichever came first.
Part 1 and Part 2: Incidence of clinically significant abnormal ECGs.
Time frame: From the first dose to earliest of 28 days post last dosing date or day of new anticancer therapy -1 day.
15 secondary outcomes
Part1 and Part 2: Maximum Observed Plasma Concentration (Cmax); Single Dose (SD)
Time frame: Cycle 1 (Pre-dose, Day 1, 8, and 15) and Cycle 2 (Day 1). Each cycle is 28 days.
Part 1 and Part 2: Time to Reach Maximum Observed Plasma Concentration (Tmax); Single Dose (SD)
Time frame: Cycle 1 (Pre-dose, Day 1, 8, and 15) and Cycle 2 (Day 1). Each cycle is 28 days.
Part 1: Area under the concentration-time curve from 0 to time of last measurable concentration (AUClast)
Time frame: Cycle 1 (Pre-dose, Day 1, 8, and 15) and Cycle 2 (Day 1). Each cycle is 28 days.
Part 1 and Part 2: Maximum Observed Plasma concentration (Cmax,ss), steady state
Time frame: Cycle 1 (Pre-dose, Day 1, 8, and 15) and Cycle 2 (Day 1). Each cycle is 28 days.
Part 1 and Part 2: Time to Reach Maximum Observed Plasma Concentration steady state (Tmax, ss)
Time frame: Cycle 1 (Pre-dose, Day 1, 8, and 15) and Cycle 2 (Day 1). Each cycle is 28 days.
Part 1 and Part 2: Minimum Observed Plasma Concentration (Cmin, ss), steady state
Time frame: Cycle 1 (Pre-dose, Day 1, 8, and 15) and Cycle 2 (Day 1). Each cycle is 28 days.
Part 1: Area Under the concentration-time curve from 0 to time the end of the dosing interval (AUCtau,ss), steady state
Time frame: Cycle 1 (Pre-dose, Day 1, 8, and 15) and Cycle 2 (Day 1). Each cycle is 28 days.
Part 2: Accumulation ratio (Rac)
Time frame: Cycle 1 (Pre-dose, Day 1, 8, and 15) and Cycle 2 (Day 1). Each cycle is 28 days.
Part 1: Objective Response, as assessed using RECIST version 1.1.
Time frame: From baseline and up to approximately 24 months
Part 1 and Part 2: Duration of Response (DoR) of PF-07224826 alone or in combination with fulvestrant
Time frame: From baseline and up to approximately 24 months
Part 1 and Part 2: Progression-Free Survival (PFS) of PF-07224826 alone or in combination with fulvestrant
Time frame: From baseline and up to approximately 24 months
Part 1 and Part 2: Time to Response (TTR) of PF-07224826 alone or in combination with fulvestrant
Time frame: From baseline and up to approximately 24 months
Part 2: Overall Survival (OS) of PF-07224826 with fulvestrant
Time frame: From baseline and up to approximately 24 months
Part 2: Clinical benefit response (CBR) of PF-07224826 with fulvestrant
Time frame: From baseline and up to approximately 24 months
Part 1 and Part 2: Expression of Pharmacodynamic (PD) biomarkers in tumor tissue
Time frame: From baseline and up to approximately 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-07224826 and Fulvestrant in people with Breast Cancer and Ovarian Cancer, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: First cycle dose limiting toxicities (DLTs) (time frame: Cycle 1 (28 days)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.