Phase i dose-escalation study of pilaralisib (SAR245408, XL147) in combination with paclitaxel and carboplatin in patients with solid tumors

Oncologist

Volumn 22, Issue 4, 2017, Pages

  Wheler, Jennifer ^a   Mutch, David ^b   Lager, Joanne ^c   Castell, Christelle ^d   Liu, Li ^d   Jiang, Jason ^d   Traynor, Anne M ^e  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^b WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c SANOFI   (United States)

^d SANOFI   (France)

^e UNIVERSITY OF WISCONSIN   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CARBOPLATIN; MITOGEN ACTIVATED PROTEIN KINASE; PACLITAXEL; PHOSPHATIDYLINOSITOL 3 KINASE; PILARALISIB; ANTINEOPLASTIC AGENT; PROTEIN KINASE INHIBITOR; QUINOXALINE DERIVATIVE; SULFONAMIDE;

ADULT; AGED; ALOPECIA; ANEMIA; ARTICLE; CANCER SURVIVAL; DECREASED APPETITE; DIARRHEA; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG SAFETY; DYSPNEA; ENDOMETRIUM CARCINOMA; FATIGUE; FEMALE; HUMAN; HYPOMAGNESEMIA; LEUKOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RASH; SOLID TUMOR; SQUAMOUS CELL CARCINOMA; THROMBOCYTE COUNT; THROMBOCYTOPENIA; URINARY TRACT INFECTION; VOMITING; ADVERSE DRUG REACTION; ANTAGONISTS AND INHIBITORS; CLINICAL TRIAL; MIDDLE AGED; NEOPLASM; PATHOLOGY; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARBOPLATIN; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASMS; PACLITAXEL; PHOSPHATIDYLINOSITOL 3-KINASES; PROTEIN KINASE INHIBITORS; QUINOXALINES; SULFONAMIDES;

EID: 85017466536     PISSN: 10837159     EISSN: 1549490X     Source Type: Journal    
DOI: 10.1634/theoncologist.2016-0257     Document Type: Article

References (16)

1. Goldfinger M, Diaz I, Muggia F. Systemic treatment of endometrial cancer: What is doxorubicin’s role? J Clin Oncol 2014; 32: 2181-2182.
2. Cantley LC. The phosphoinositide 3-kinase pathway. Science 2002; 296: 1655-1657.
3. Salvesen HB, Carter SL, Mannelqvist M et al. Integrated genomic profiling of endometrial carcinoma associates aggressive tumors with indicators of PI3 kinase activation. Proc Natl Acad Sci USA 2009; 106: 4834-4839.
4. Samuels Y, Wang Z, Bardelli A et al. High frequency of mutations of the PIK3CA gene in human cancers. Science 2004; 304: 554.
5. Zhao L, Vogt PK. Class I PI3K in oncogenic cellular transformation. Oncogene 2008; 27: 5486-5496.
6. Engelman JA, Luo J, Cantley LC. The evolution of phosphatidylinositol 3-kinases as regulators of growth and metabolism. Nat Rev Genet 2006; 7: 606-619.
7. Liu P, Cheng H, Roberts TM et al. Targeting the phosphoinositide 3-kinase pathway in cancer. Nat Rev Drug Discov 2009; 8: 627-644.
8. Hu L, Hofmann J, Lu Y et al. Inhibition of phosphatidylinositol 3'-kinase increases efficacy of paclitaxel in in vitro and in vivo ovarian cancer models. Cancer Res 2002; 62: 1087-1092.
9. Mondesire WH, Jian W, Zhang H et al. Targeting mammalian target of rapamycin synergistically enhances chemotherapy-induced cytotoxicity in breast cancer cells. Clin Cancer Res 2004; 10: 7031-7042.
10. Aissat N, Le Tourneau C, Ghoul A et al. Antiproliferative effects of rapamycin as a single agent and in combination with carboplatin and paclitaxel in head and neck cancer cell lines. Cancer Chemother Pharmacol 2008; 62: 305-313.
11. Shapiro GI, Rodon J, Bedell C et al. Phase I safety, pharmacokinetic, and pharmacodynamic study of SAR245408 (XL147), an oral pan-class I PI3K inhibitor, in patients with advanced solid tumors. Clin Cancer Res 2014; 20: 233-245.
12. Matulonis U, Vergote I, Backes F et al. Phase II study of the PI3K inhibitor pilaralisib (SAR245408; XL147) in patients with advanced or recurrent endometrial carcinoma. Gynecol Oncol 2015; 136: 246-253.
13. Bendell JC, Rodon J, Burris HA et al. Phase I, dose-escalation study of BKM120, an oral pan-Class I PI3K inhibitor, in patients with advanced solid tumors. J Clin Oncol 2012; 30: 282-290.
14. Markman B, Tabernero J, Krop I et al. Phase I safety, pharmacokinetic, and pharmacodynamic study of the oral phosphatidylinositol-3-kinase and mTOR inhibitor BGT226 in patients with advanced solid tumors. Ann Oncol 2012; 23: 2399-2408.
15. Rodon J, Braña I, Siu LL et al. Phase I doseescalation and -expansion study of buparlisib (BKM120), an oral pan-Class I PI3K inhibitor, in patients with advanced solid tumors. Invest New Drugs 2014; 32: 670-681.
16. Papadopoulos K, Tabernero J, Markman B et al. Phase I safety, pharmacokinetic and pharmacodynamic study of SAR245409 (XL765), a novel, orally administered PI3K/mTOR inhibitor in patients with advanced solid tumors. Clin Cancer Res 2014; 20: 2445-2456.