Trial · NCT07897721
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1 (Dose Escalation): Number of participants with Dose-Limiting Toxicities (DLT) | Baseline up to 28 days | 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. |
| Primary | Part 1 (Dose Escalation): Incidence of Adverse Events (AEs) | From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first | 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. |
| Primary | Part 1 (Dose Escalation): Number of participants with laboratory abnormalities | From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first | Number of participants with laboratory test abnormalities. |
| Primary | Part 2 (Dose Expansion): Objective Response Rate (ORR) | Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) | ORR defined as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). |
| Secondary | Part 1: Objective Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) | Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) | 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. |
| Secondary | Part 1 & Part 2: Disease Control Rate (DCR) as per RECIST v1.1 | Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) | DCR is defined as the proportion of participants with CR or PR with confirmation, or Stable Disease (SD) per RECIST version 1.1. |
| Secondary | Part 1 & Part 2: Clinical Benefit Rate (CBR) as per RECIST v1.1 | Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) | 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. |
| Secondary | Part 1 & Part 2: Duration of Response (DOR) as per RECIST v1.1 | Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) | 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. |
| Secondary | Part 1 & Part 2: Progression-Free Survival (PFS) as per RECIST v1.1 | Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) | PFS is defined as time from start date of treatment to the date of first documentation of PD or death due to any cause. |
| Secondary | Part 1 & Part 2: Time to Response (TTR) as per RECIST v1.1 | Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years) | TTR is defined as the time from start date of treatment to first documentation of CR or PR. |
| Secondary | Part 1: Maximum Observed Serum Concentration (Cmax) & Trough Concentration (Ctrough) | Baseline through end of Cycle 1 (each cycle is 28 days) | Evaluate the single and multiple dose pharmacokinetic (s) (PK) of PF-08165784 as monotherapy, or in combination with other anti-tumor agents. |
| Secondary | Part 1: Time to Reach Maximum Observed Serum Concentration (Tmax) | Baseline through end of Cycle 1 (each cycle is 28 days) | Evaluate the single and multiple dose PK of PF-08165784 as monotherapy, or in combination with other anti-tumor agents. |
| Secondary | Part 1: Area Under the Curve (AUC) from Time Zero to Last Quantifiable Concentration (AUClast) | Baseline through end of Cycle 1 (each cycle is 28 days) | Evaluate the single and multiple dose PK of PF-08165784 as monotherapy, or in combination with other anti-tumor agents. |
| Secondary | Part 1: Effect of Food on Cmax | Baseline through end of Cycle 1 (each cycle is 28 days) | Evaluate the effect of food on Cmax of PF-08165784 as monotherapy |
| Secondary | Part 1: Effect of Food on Tmax | Baseline through end of Cycle 1 (each cycle is 28 days) | Evaluate the effect of food on Tmax of PF-08165784 as monotherapy |
| Secondary | Part 1: Effect of Food on AUClast | Baseline through end of Cycle 1 (each cycle is 28 days) | Evaluate the effect of food on AUClast of PF-08165784 as monotherapy |
| Secondary | Part 2 (Dose Expansion): Number of participants with laboratory abnormalities | From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first | Number of participants with laboratory test abnormalities. |
| Secondary | Part 2 (Dose Expansion): Incidence of Adverse Events (AEs) | From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first | 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. |
| Secondary | Part 2 (Dose Expansion): Pre- and post-dose concentrations of PF-08165784 | Baseline through end of Cycle 1 (each cycle is 28 days) | Evaluate the pre- and post-dose concentrations of PF-08165784 |
| Secondary | Part 2: Overall Survival (OS) | Up to approximately 2 years | OS is defined as time from from start date of treatment to the date of death due to any cause |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT07897721/registered