التفاصيل البيبلوغرافية
| العنوان: |
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. |
| المؤلفون: |
Curigliano, Giuseppe, Shapiro, Geoffrey I., Kristeleit, Rebecca S., Abdul Razak, Albiruni R., Leong, Stephen, Alsina, Maria, Giordano, Antonio, Gelmon, Karen A., Stringer-Reasor, Erica, Vaishampayan, Ulka N., Middleton, Mark, Olszanski, Anthony J., Rugo, Hope S., Kern, Kenneth A., Pathan, Nuzhat, Perea, Rachelle, Pierce, Kristen J., Mutka, Sarah C., Wainberg, Zev A. |
| المصدر: |
British Journal of Cancer; Jan2023, Vol. 128 Issue 1, p30-41, 12p |
| مستخلص: |
Background: This Phase 1b study (B2151002) evaluated the PI3K/mTOR inhibitor gedatolisib (PF-05212384) in combination with other anti-tumour agents in advanced solid tumours.Methods: Patients with various malignancies were administered gedatolisib (90‒310 mg intravenously every week [QW]) plus docetaxel (arm A) or cisplatin (arm B) (each 75 mg/m2 intravenously Q3W) or dacomitinib (30 or 45 mg/day orally). The safety and tolerability of combination therapies were assessed during dose escalation; objective response (OR) and safety were assessed during dose expansion.Results: Of 110 patients enrolled, 107 received gedatolisib combination treatment. Seven of 70 (10.0%) evaluable patients had dose-limiting toxicities; the most common was grade 3 oral mucositis (n = 3). Based upon reprioritisation of the sponsor's portfolio, dose expansion focused on arm B, gedatolisib (180 mg QW) plus cisplatin in patients (N = 22) with triple-negative breast cancer (TNBC). OR (95% CI) was achieved in four of ten patients in first-line (overall response rate 40.0% [12.2-73.8%]) and four of 12 in second/third-line (33.3% [9.9-65.1%]) settings. One patient in each TNBC arm (10%, first-line; 8.3%, second/third-line) achieved a complete response.Conclusions: Gedatolisib combination therapy showed an acceptable tolerability profile, with clinical activity at the recommended Phase 2 dose in patients with TNBC.Clinical Trial: ClinicalTrial.gov: NCT01920061. [ABSTRACT FROM AUTHOR] |
|
Copyright of British Journal of Cancer is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) |
| قاعدة البيانات: |
Complementary Index |
Full Text Finder