Purpose: Preclinical models showed TAC-101 (4-[3,5-bis(trimethylsilyl) benzamide] benzoic acid), an oral synthetic retinoid, has anti-tumor activity in hepatocellular carcinoma (HCC). A phase I/II study was performed in advanced HCC patients (pts).
Patients And Methods: Thirty-three patients were enrolled. During Phase I, pts received 40 mg daily for 14 days q3 weeks; 2 of 5 patients developed DLT so dose was reduced to 20 mg/day. Twenty-eight patients received 20 mg/day.
Results: No pt had a CR or PR, but 12 of 21 (57%) had SD. Two pts (9.5%) had late PR after discontinuing TAC-101. Median survival (MS) for all 28 pts treated with 20 mg/day was 12.7 months (95% CI 8.8-22.7); MS for 21 evaluable pts was 19.2 months (95% CI 10.4-27.6).
Conclusions: 20 mg of TAC- was well tolerated. Significant disease stabilization (12/21 pts, 57%), 2 late PRs, and prolonged MS (19.2 months) suggest that TAC-101 provides meaningful patient benefit.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1007/s00432-008-0406-2 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
F-Prostate-Specific Membrane Antigen PET/CT imaging for potentially resectable pancreatic cancer (PANSCAN-2): a phase I/II study.
Cancer Imaging
January 2025
Department of Surgery, Amsterdam UMC Location Vrije Universiteit Amsterdam, De Boelelaan 1117, Amsterdam, the Netherlands.
Background: Current diagnostic imaging modalities have limited ability to differentiate between malignant and benign pancreaticobiliary disease, and lack accuracy in detecting lymph node metastases. F-Prostate-Specific Membrane Antigen (PSMA) PET/CT is an imaging modality used for staging of prostate cancer, but has incidentally also identified PSMA-avid pancreatic lesions, histologically characterized as pancreatic ductal adenocarcinoma (PDAC). This phase I/II study aimed to assess the feasibility of F-PSMA PET/CT to detect PDAC.
View Article and Find Full Text PDFTime to weight plateau with tirzepatide treatment in the SURMOUNT-1 and SURMOUNT-4 clinical trials.
Clin Obes
January 2025
Eli Lilly and Company, Indianapolis, Indiana, USA.
The rate of weight reduction during obesity treatment declines over time and eventually reaches a weight plateau. We investigated factors associated with time to weight plateau (TTWP) in tirzepatide-treated participants with obesity or overweight in a post-hoc analysis of SURMOUNT-1 and SURMOUNT-4 trials. Participants adherent to tirzepatide treatment and achieving ≥5% weight loss by primary endpoint (week 72 SURMOUNT-1; week 88 SURMOUNT-4) were included.
View Article and Find Full Text PDFPhase I-II study of prone hypofractionated accelerated breast and nodal intensity modulated radiation therapy.
Int J Radiat Oncol Biol Phys
January 2025
Department of Radiation Oncology, New York University Langone Health and Perlmutter Cancer Center, New York, NY.
Background: In patients with breast cancer, prone radiation therapy (RT) has been shown to reduce heart and lung dose. Though prone positioning is routinely used for whole breast RT, its use when treating the regional lymph nodes (RLNs) is not widespread.
Methods: In this phase I-II trial for stage IB-IIA breast cancer treated with lumpectomy or mastectomy, patients received 40.
Bayesian item response theory to estimate power in clinical trials with patient-reported outcomes as endpoints.
Qual Life Res
January 2025
Department of Biostatistics and Data Science, University of Kansas Medical Center, Kansas City, KS, USA.
Purpose: Patient-Reported Outcomes (PROs) are widely used in clinical trials, epidemiological research, quality of life (QOL) studies, routine clinical care, and medical surveillance. The Patient Reported Outcomes Measurement Information System (PROMIS) is a system of reliable and standardized measures of PROs developed with Item Response Theory (IRT) using latent scores. Power estimation is critical to clinical trials and research designs.
View Article and Find Full Text PDFEnhanced D614G and Omicron Variants Antibody Persistence in Infants at 2 Months of Age Following Maternal mRNA Booster Vaccination During Pregnancy or Postpartum.
Pediatr Infect Dis J
November 2024
National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD.
Background: Following maternal COVID-19 vaccination, the persistence of antibodies in sera and breast milk for mothers and infants is not well characterized. We sought to describe the persistence of antibodies through 2 months after delivery in maternal and infant serum and breast milk following maternal COVID-19 mRNA vaccination and to examine differences by receipt of booster dose during pregnancy or postpartum.
Methods: This is a prospective cohort study with enrollment from July 2021 to January 2022 at 9 US academic sites.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!