A Study to Learn About the Study Medicine Called PF-08165784 in People With PIK3CA-Mutated Advanced or Metastatic Solid Tumors

Browse trials for

• Breast Neoplasms 12,828
• Carcinoma 6,715
• Colonic Neoplasms 1,488

Keywords

• Carcinoma, Breast, Estrogen Receptor Positive Breast Cancer, HER2- Breast Cancer, Colon Cancer, PI3K mutation

Breast Neoplasms

12,828 studies on the registry are indexed under Breast Neoplasms; 2,923 are open to participants now.

This study's planned enrollment of 268 is above the median of 72 across 9,498 interventional studies indexed under Breast Neoplasms.

Lead sponsor

Pfizer is the lead sponsor of 3,326 studies on the registry; 147 are open to participants now.

Of its 598 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Study arms

• Experimental
  Part 1 Dose Escalation Cohort 1A

  PF-08165784 monotherapy dose escalation for participants with advanced or metastatic BC at different doses of the study drug

  Drug: PF-08165784

• Experimental
  Part 1 Dose Escalation Cohort 1B

  Combination (PF-08165784 + fulvestrant) dose escalation for participants with advanced or metastatic BC, at different doses of the study drug

  Drug: PF-08165784 · Drug: Fulvestrant

• Experimental
  Part 1 Dose Escalation Cohort 1C

  Combination (PF-08165784 + fulvestrant + atirmociclib) dose escalation for participants with advanced or metastatic BC, at different doses of the study drug

  Drug: PF-08165784 · Drug: Fulvestrant · Drug: Atirmociclib

• Experimental
  Part 1 Dose Escalation Cohort 1D

  Combination (PF-08165784 + cetuximab) dose escalation for participants with advanced or metastatic CRC at different doses of the study drug

  Drug: PF-08165784 · Drug: Cetuximab

• Experimental
  Part 2 Dose Optimization/Expansion Cohort 2A

  Combination (PF-08165784 + letrozole + atirmociclib) dose optimization/expansion for participants with advanced or metastatic BC, at different doses of the study drug

  Drug: PF-08165784 · Drug: Atirmociclib · Drug: Letrozole

Interventions

• DrugPF-08165784

  Taken by mouth (PO)

• DrugFulvestrant

  Selective Estrogen Receptor Degrader (SERD)

  Also known as: Faslodex

• DrugAtirmociclib

  Selective cyclin-dependent kinase 4 (CDK4) inhibitor

  Also known as: PF-07220060

• DrugCetuximab

  Monoclonal antibody (EGFR inhibitor)

  Also known as: Erbitux

• DrugLetrozole

  Nonsteroidal aromatase inhibitor

  Also known as: Femara

Primary outcomes

1. Part 1 (Dose Escalation): Number of participants with Dose-Limiting Toxicities (DLT)

   Any adverse events that are attributable to one, the other, or both study treatments, occurring in the DLT observation period are considered DLTs, excluding toxicities clearly due to underlying disease or extraneous causes.

   Time frame: Baseline up to 28 days

2. Part 1 (Dose Escalation): Incidence of Adverse Events (AEs)

   An adverse event (AE) was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.

   Time frame: From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first

3. Part 1 (Dose Escalation): Number of participants with laboratory abnormalities

   Number of participants with laboratory test abnormalities.

   Time frame: From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first

4. Part 2 (Dose Expansion): Objective Response Rate (ORR)

   ORR defined as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

   Time frame: Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years)

Secondary outcomes

1. Part 1: Objective Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

   ORR is defined as the percentage of participants in the analysis population having a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST v1.1.

   Time frame: Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years)

2. Part 1 & Part 2: Disease Control Rate (DCR) as per RECIST v1.1

   DCR is defined as the proportion of participants with CR or PR with confirmation, or Stable Disease (SD) per RECIST version 1.1.

   Time frame: Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years)

3. Part 1 & Part 2: Clinical Benefit Rate (CBR) as per RECIST v1.1

   CBR is defined as the percentage of participants with a best overall response of CR or PR at any time before Progressive Disease (PD), or non-CR/non-PD or SD for at least 24 weeks from start date of treatment and prior to PD, relative to the appropriate analysis set.

   Time frame: Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years)

4. Part 1 & Part 2: Duration of Response (DOR) as per RECIST v1.1

   DOR is defined as the time from first documentation of CR or PR to date of first documentation of PD or death due to any cause.

   Time frame: Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years)

5. Part 1 & Part 2: Progression-Free Survival (PFS) as per RECIST v1.1

   PFS is defined as time from start date of treatment to the date of first documentation of PD or death due to any cause.

   Time frame: Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years)

6. Part 1 & Part 2: Time to Response (TTR) as per RECIST v1.1

   TTR is defined as the time from start date of treatment to first documentation of CR or PR.

   Time frame: Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years)

7. Part 1: Maximum Observed Serum Concentration (Cmax) & Trough Concentration (Ctrough)

   Evaluate the single and multiple dose pharmacokinetic (s) (PK) of PF-08165784 as monotherapy, or in combination with other anti-tumor agents.

   Time frame: Baseline through end of Cycle 1 (each cycle is 28 days)

8. Part 1: Time to Reach Maximum Observed Serum Concentration (Tmax)

   Evaluate the single and multiple dose PK of PF-08165784 as monotherapy, or in combination with other anti-tumor agents.

   Time frame: Baseline through end of Cycle 1 (each cycle is 28 days)

9. Part 1: Area Under the Curve (AUC) from Time Zero to Last Quantifiable Concentration (AUClast)

   Evaluate the single and multiple dose PK of PF-08165784 as monotherapy, or in combination with other anti-tumor agents.

   Time frame: Baseline through end of Cycle 1 (each cycle is 28 days)

10. Part 1: Effect of Food on Cmax

    Evaluate the effect of food on Cmax of PF-08165784 as monotherapy

    Time frame: Baseline through end of Cycle 1 (each cycle is 28 days)

11. Part 1: Effect of Food on Tmax

    Evaluate the effect of food on Tmax of PF-08165784 as monotherapy

    Time frame: Baseline through end of Cycle 1 (each cycle is 28 days)

12. Part 1: Effect of Food on AUClast

    Evaluate the effect of food on AUClast of PF-08165784 as monotherapy

    Time frame: Baseline through end of Cycle 1 (each cycle is 28 days)

13. Part 2 (Dose Expansion): Number of participants with laboratory abnormalities

    Number of participants with laboratory test abnormalities.

    Time frame: From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first

14. Part 2 (Dose Expansion): Incidence of Adverse Events (AEs)

    An adverse event (AE) was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.

    Time frame: From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first

15. Part 2 (Dose Expansion): Pre- and post-dose concentrations of PF-08165784

    Evaluate the pre- and post-dose concentrations of PF-08165784

    Time frame: Baseline through end of Cycle 1 (each cycle is 28 days)

16. Part 2: Overall Survival (OS)

    OS is defined as time from from start date of treatment to the date of death due to any cause

    Time frame: Up to approximately 2 years

Related links

• To obtain contact information for a study center near you, click here. ↗

Individual participant data

Plan to share: 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.