clinical trials

 
Study No.
Study Title
Phase
Route
No. of Patients
Status
 
Reference
Pracinostat
       
SB939-2006-001
A phase I dose escalation study of oral SB939 when administered thrice weekly (every other day) for 3 weeks in a 4-week cycle in patients with advanced malignanciesIOral30Closed 
Yong WP, Goh BC, Soo RA, Toh HC, Ethirajulu K, Wood J, Novotny-Diermayr V, Lee SC, Yeo WL, Chan D, Lim D, Seah E, Lim R, Zhu J. Ann Oncol. 2011 Nov;22(11):2516-22. [ Abstract ]
SB939-2007-002
A phase I clinical and pharmacokinetic study of SB939 in patients with advanced cancerIOral38Closed 
Razak ARA, Hotte SJ, Siu LL, Chen EX, Hirte HW, Powers J, Walsh W, Stayner LA, Laughlin A, Novotny-Diermayr V, Zhu J, Eisenhauer EA. Br J Cancer. 2011 Mar 1; 104(5): 756-762. [ Full article ]
2010-0319A phase 2, prospective, open-label study to determine the safety and efficacy of SB939, a histone deacetylase inhibitor, in subjects with primary, post-polycythemia vera, or post-essential thrombocythemia myelofibrosisIIOral22Closed 
Quintas-Cardama A, Kantarjian H, Estrov Z, Borthakur G, Cortes J, Verstovsek S. Leuk Res. 2012 Sep;36(9):1124-7. [ Abstract ]
ME-344
      
ME-344-001
Phase 1 open label dose escalation study of the safety and pharmacokinetics of ME-344 as a single agent in patients with refractory solid tumors
IIVUp to 24
Open
 
ME-143
      
ME-143-001
Phase I open label dose escalation study of the safety and pharmacokinetics of ME-143 as a single agent in patients with refractory solid tumors
I
IV
Up to 21
Open
 
Kurkjian C, Pant S, Burris HA, Bendell JC, Jones SF, Moore KN, Moreno O, Mass RD, Infante JR. ASCO Annual Meeting, Jun 2012. [ Poster ]
Triphendiol
       
NV196-0001
Phase Ia safety & pharmacokinetic study of oral NV-196 in patients with solid tumors
Ia
Oral
12
Closed
 
Mainwaring PN, West L, Husband AJ. J Clin Oncol. 2008 May;26(15S):14615. [ Abstract ]
Phenoxodiol
       
NV06-0022
Phase I and pharmacokinetic study of weekly NV-06 in patients with advanced malignancies
I
IV
21
Closed
 
de Souza PL, Liauw W, Links M, Pirabhahar S, Kelly G, Howes LG. Cancer Chemother Pharmacol. 2006 Oct;58(4):427-33. [ Full article ]
NV06-0024
Phase Ib study of phenoxodiol given by constant intravenous infusion in patients with solid neoplasms (with the exception of breast cancer) whose tumors are refractory to standard therapy
Ib
IV
19
Closed
 
Choueiri TK, Mekhail T, Hutson TE, Ganapathi R, Kelly GE, Bukowski RM. Ann Oncol. 2006 May;17(5):860-5. [ Full article ]
NV06-0025
Phase I/II pharmacokinetic and safety study of oral phenoxodiol in patients with hormone-refractory prostatic adenocarcinoma
I/II
Oral
30
Closed
 
Davies R, Tulloch A, Frydenberg M, Kelly G. AACR Basic, Translational and Clinical Advances in Prostate Cancer Conference, Nov 2004. [ Poster ]
NV06-0029
Multi-center phase Ib/II study of phenoxodiol in patients with recurrent ovarian, fallopian and primary peritoneal cancer that is resistant to second line chemotherapy
Ib/II
IV
41
Closed
 
Rutherford T, O’Malley D, Makkenchery A, Baker L, Azodi M, Schwartz P, Mor G. AACR Annual Meeting, Mar 2004. [ Abstract ]
NV06-0031
Phase Ib safety and efficacy study of neoadjuvant use of oral phenoxodiol in patients with primary diagnosis of squamous cell carcinoma or adenocarcinoma of the cervix, vagina or vulva
Ib
Oral
26
Closed
 
Azodi M, Kelly M, Rutherford T, Schwartz P, Baker L, Mor G, Kelly G. AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, Nov 2005. [ Poster ]
NV06-0037
Multi-center, phase Ib/IIa safety and preliminary efficacy study of phenoxodiol (intravenous dosage form and oral dosage form) as a chemo-sensitizing agent for cisplatin, carboplatin and paclitaxel in epithelial ovarian cancer or primary peritoneal cancer that is platinum- and/or taxane-refractory or resistant
Ib/IIa
IV/Oral
65
Closed
 
Kelly MG, Mor G, Husband A, O'Malley DM, Baker L, Azodi M, Schwartz PE, Rutherford TJ. Int J Gynecol Cancer, 2011 May;21(4):633-9. [ Abstract ]
NV06-0039
(OVATURE)
Multi-center, randomized, double-blind, phase III efficacy study comparing phenoxodiol (oral dosage form) in combination with carboplatin versus carboplatin with placebo in patients with platinum-resistant or platinum-refractory late-stage epithelial ovarian, fallopian or primary peritoneal cancer following at least second line platinum therapy
III
Oral
142
Closed
 
MEI Pharma Announces Final Results from Halted Phase 3 Clinical Trial of Phenoxodiol, Jun 2010. [ Press release ]
0703002467
Phase II trial of phenoxodiol in patients with castrate and non-castrate prostate cancer
II
Oral
27
Closed
 
Gibney G, Elfiky A, Bussom S, Hoimes CJ, Burns A, McDonough JA, Rowen E, Cheng YC, Kelly WK. ASCO Annual Meeting, Jun 2010. [ Abstract ]