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| ID | Type | Description | Link |
|---|---|---|---|
| KAT2i | Other Identifier | Alias Study Number |
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This is an open-label, dose escalation and dose expansion study evaluating the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD), and antitumor activity of PF-07994525 in participants with R/R MM.
The study will consist of 2 parts: Part 1 (Dose Escalation) will consist of PF-07994525 dose escalation to assess the safety, tolerability, and preliminary antitumor activity in participants with R/R MM. In Part 2 (Dose expansion), PF-07994525 may be evaluated in additional participants with R/R MM to further assess safety, PK, PD, and preliminary anti-tumor activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | Monotherapy Dose Escalation |
|
| Part 2 | Experimental | Monotherapy Dose Expansion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07994525 | Drug | Oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Type, incidence and severity of participants with adverse events (AEs) | Type, incidence, severity (graded by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0), timing, seriousness, and relatedness of adverse events (AEs) | From the first day through 30-37 days after the last study treatment, up to approximately 2 years |
| Type, incidence and severity of participants with laboratory abnormalities | Type, incidence, and severity (graded by NCI CTCAE version 5.0) of laboratory abnormalities | From the first day through 30-37 days after the last study treatment, up to approximately 2 years |
| Number of participants with dose modifications | Frequency of dose modifications (eg, dose delay, treatment interruptions, dose reductions, and treatment discontinuations) due to AEs | From the first day through 30-37 days after the last study treatment, up to approximately 2 years |
| Part 1: Number of Participants With Dose-limiting Toxicities (DLTs) | Occurrence of DLTs as defined by the protocol | Baseline to end of DLT evaluation period |
| Part 1: Recommended Monotherapy Dose for Expansion (RDE) | RDE will be based on cumulative safety, preliminary antitumor activity and pharmacokinetics findings | From the first day through 30-37 days after the last study treatment, up to approximately 2 years |
| Part 2: Recommended Dose for future development | Safety, and preliminary anti-tumor activity |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) per International Myeloma Working Group (IMWG) response criteria as determined by investigator. | Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years) | |
| Complete response rate (CRR) per International Myeloma Working Group (IMWG) response criteria as determined by investigator. |
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Inclusion Criteria:
Measurable disease based on IMWG criteria as defined by at least 1 of the following:
Serum M-protein >0.5 g/dL by serum protein electrophoresis (SPEP)
Urinary M-protein excretion >200 mg/24 hours by urine protein electrophoresis (UPEP)
Serum immunoglobulin Free Light Chain (FLC) ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarah Cannon Research Institute - Pharmacy | Recruiting | Nashville | Tennessee | 37203 | United States | |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Midazolam |
| Drug |
Oral administration |
|
| From the first day through 30-37 days after the last study treatment, up to approximately 2 years |
| Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years) |
| Time to response (TTR) per IMWG as determined by investigator | Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years) |
| Duration of response (DOR) per IMWG as determined by investigator | Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years) |
| Duration of complete response (DOCR) per IMWG as determined by investigator | Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years) |
| Progression-free survival (PFS) per IMWG as determined by investigator | Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years) |
| Overall survival (OS) | Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years) |
| Single, Multiple Dose and food effect: Maximum Observed Concentration (Cmax) | Pharmacokinetic (PK) assessments for PF-07994525 | From the first day through 30-37 days after the last study treatment, up to approximately 2 years |
| Single, Multiple Dose and food effect: Time to Maximum concentration (Tmax) | Pharmacokinetic (PK) assessments for PF-07994525 | From the first day through 30-37 days after the last study treatment, up to approximately 2 years |
| Single, Multiple Dose and food effect: AUC from time zero to time of last measurable concentration (AUClast) | Pharmacokinetic (PK) assessments for PF-07994525 | From the first day through 30-37 days after the last study treatment, up to approximately 2 years |
| Single Dose and food effect: Terminal Elimination half-life (t1/2) as data permit | Pharmacokinetic (PK) assessments for PF-07994525 | From the first day through 30-37 days after the last study treatment, up to approximately 2 years |
| Single Dose and food effect: AUC versus time curve from time 0 extrapolated to infinity (AUCinf) as data permit | Pharmacokinetic (PK) assessments for PF-07994525 | From the first day through 30-37 days after the last study treatment, up to approximately 2 years |
| Single, Multiple Dose and food effect: apparent clearance of drug (CL/F) as data permit | Pharmacokinetic (PK) assessments for PF-07994525 | From the first day through 30-37 days after the last study treatment, up to approximately 2 years |
| Single, Multiple Dose and food effect: Apparent volume of distribution during terminal phase (Vz/F) as data permit | Pharmacokinetic (PK) assessments for PF-07994525 | From the first day through 30-37 days after the last study treatment, up to approximately 2 years |
| Multiple Dose: AUC at steady state over the dosing interval (AUCtau) as data permit | Pharmacokinetic (PK) assessments for PF-07994525 | From the first day through 30-37 days after the last study treatment, up to approximately 2 years |
| Multiple Dose: Cmin as data permit | Pharmacokinetic (PK) assessments for PF-07994525 | From the first day through 30-37 days after the last study treatment, up to approximately 2 years |
| Multiple Dose: Accumulation ratio (Rac) as data permit | Pharmacokinetic (PK) assessments for PF-07994525 | From the first day through 30-37 days after the last study treatment, up to approximately 2 years |
| AUC from time zero to time of last measurable concentration (AUClast) | PK parameters of CYP3A4 probe substrate midazolam with and without PF-07994525 | From the first day through 30-37 days after the last study treatment, up to approximately 2 years |
| Time to Maximum concentration (Tmax) | PK parameters of CYP3A4 probe substrate midazolam with and without PF-07994525 | From the first day through 30-37 days after the last study treatment, up to approximately 2 years |
| Maximum Observed Concentration (Cmax) | PK parameters of CYP3A4 probe substrate midazolam with and without PF-07994525 | From the first day through 30-37 days after the last study treatment, up to approximately 2 years |
| SCRI Oncology Partners |
| Recruiting |
| Nashville |
| Tennessee |
| 37203 |
| United States |
| Tristar BMT | Recruiting | Nashville | Tennessee | 37203 | United States |
| TriStar Centennial Medical center | Recruiting | Nashville | Tennessee | 37203 | United States |
| D006571 | Heterocyclic Compounds |