clinical trials


Study No.	Study Title	Phase	Route	No. of Patients	Status	Reference
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	I	IV	Up to 24	Open	ClinicalTrials.gov

ME-143
ME-143-001	Phase 1 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. [ Abstract ]

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 March 15. [Epub ahead of print] [ 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	Marshall Edwards Announces Final Results from Halted Phase 3 Clinical Trial of Phenoxodiol, Jun 2010. [ Press release ]
27640	Randomized placebo-controlled phase Ib/IIa safety, tolerability and efficacy study of oral phenoxodiol in combination with docetaxel versus docetaxel alone in patients with recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer	Ib/IIa	Oral	30	Closed
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 ]