Publications by authors named "Kristen J Pierce"
Bacillus Calmette-Guérin (BCG) is the standard of care for patients with high-risk non-muscle-invasive bladder cancer (NMIBC) after transurethral resection of bladder tumor (TURBT). BCG in combination with programmed cell death-1 (PD-1) inhibitors may yield greater anti-tumor activity compared with either agent alone. CREST is a phase III study evaluating the efficacy and safety of the subcutaneous PD-1 inhibitor sasanlimab in combination with BCG for patients with BCG-naive high-risk NMIBC.
View Article and Find Full Text PDFCorrection to: A Phase 1B open-label study of gedatolisib (PF-05212384) in combination with other anti-tumour agents for patients with advanced solid tumours and triple-negative breast cancer.
Br J Cancer
January 2023
A Phase 1B open-label study of gedatolisib (PF-05212384) in combination with other anti-tumour agents for patients with advanced solid tumours and triple-negative breast cancer.
Br J Cancer
January 2023
Article Synopsis
- A Phase 1b study evaluated the PI3K/mTOR inhibitor gedatolisib combined with various anti-tumor agents in patients with advanced solid tumors.
- Out of 110 patients, 107 received the combination treatment, with notable dose-limiting toxicities including grade 3 oral mucositis occurring in 10% of evaluable patients.
- The study focused on patients with triple-negative breast cancer, showing a 40% objective response rate in first-line treatment and 33.3% in second/third-line treatment, indicating potential clinical activity and acceptable tolerability for gedatolisib therapy.
Gemtuzumab ozogamicin (GO) remained available to US clinicians through an open-label expanded-access protocol (NCT02312037) until GO was reapproved. Patients were aged ≥3 months with relapsed/refractory (R/R) acute myeloid leukemia (AML), high-risk myelodysplastic syndrome, or acute promyelocytic leukemia (APL), and had exhausted other treatment options. Three hundred and thirty one patients received GO as monotherapy for R/R AML ( 139), combination therapy for R/R AML ( 183), or treatment for R/R APL ( 9).
View Article and Find Full Text PDFBackground: This phase I, four-arm, open-label study (NCT01347866) evaluated the PI3K/mTOR inhibitors PF-04691502 (arms A, B) and gedatolisib (PF-05212384; arms C, D) in combination with the MEK inhibitor PD-0325901 (arm A, D) or irinotecan (arm B, C) in patients with advanced solid tumors.
Objectives: Primary endpoint was dose-limiting toxicity with each combination. Secondary endpoints included safety, pharmacokinetics and preliminary antitumor activity.
Objective: VS-6063 (also known as defactinib or PF-04554878) is a second-generation inhibitor of focal adhesion kinase (FAK) and proline-rich tyrosine kinase-2 (Pyk2). This phase I dose-escalation study was conducted in patients with advanced solid malignancies.
Methods: Using a traditional 3 + 3 design, VS-6063 was administered orally twice daily (b.
Article Synopsis
- This study evaluates the safety, tolerability, pharmacokinetics, and preliminary activity of the intravenous drug PF-05212384 in patients with advanced solid tumors while primarily focusing on its safety.
- In part 1, researchers estimated the maximum-tolerated dose (MTD) in a diverse group of patients, while part 2 confirmed the MTD and assessed activity in specific tumor types linked to the PI3K pathway.
- Results showed a MTD of 154 mg with manageable side effects, notable antitumor activity in some patients, and promising pharmacokinetic profiles, suggesting further development is warranted for advanced cancers.
Purpose: PF-00562271 is a novel inhibitor of focal adhesion kinase (FAK). The objectives of this study were to identify the recommended phase II dose (RP2D) and assess safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of PF-00562271.
Patients And Methods: Part 1 was a dose escalation without and with food.
This phase I study (ClinicalTrials.gov ID: NCT00424632) evaluated the safe dose, pharmacokinetics, and pharmacodynamics of the aurora kinase A and B inhibitor, PF-03814735. Patients with advanced solid tumours received oral, once-daily (QD) PF-03814735 on Schedule A: days 1-5 (5-100mg); or Schedule B: days 1-10 (40-60mg) of 21-day cycles.
View Article and Find Full Text PDFPurpose: This phase I, first-in-human study evaluated the safety, tolerability, pharmacokinetics, and maximum-tolerated dose (MTD) of an oral platelet-derived growth factor receptor inhibitor, CP-868,596.
Patients And Methods: Patients with advanced solid tumors were eligible. Dose escalations were performed in three groups with two formulations: uncoated on an empty stomach (UES), uncoated with food (UFED), and film-coated (FC) without food.