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Clinical Trials

Current studies
The following studies are open and are recruiting subjects.

Study #NV06-0031

Phase Ib study of Neoadjuvant Use of Oral Phenoxodiol in Patients with Primary Diagnosis of Squamous Cell Carcinoma or Adenocarcinoma of the Cervix, Vagina or Vulva

Site:
	Yale-New Haven Hospital, New Haven, CT, USA
Eligibility:
	Patients with a primary diagnosis of squamous cell carcinoma of the cervix, vagina or vulva, or adenocarcinoma of the cervix.
Number of patients: 30
Objectives:
	The primary efficacy objective of the study is to obtain evidence of the anti-cancer activity of phenoxodiol as a mono-therapy in patients with malignant SCC of the cervix, vagina or vulva, and adenocarcinoma of the cervix. The primary safety objective is to assess the safety and tolerance to oral phenoxodiol in this patient population. A secondary efficacy objective is to correlate levels in the serum of the putative molecular target of phenoxodiol, tNOX, with clinical response, in order to evaluate this protein as a suitable biological or surrogate marker.
Treatment schedule:
	Phenoxodiol is administered in capsule form, 8-hourly over a treatment cycle of 4 weeks. Three different dosages are being used: 50 mg, 200 mg and 400 mg per dose. Each patient remains on the same dosage.
Outcomes:
	Tumor size Histological and histochemical evidence of tumor response.
Inclusion criteria:
	Patients meeting all of the following criteria will be considered for admission to the study:
	> 18 years of age. Histological evidence of invasive SCC or adenocarcinoma of the cervix, vagina or vulva. Clinically or radiologically measurable disease. Tumor mass > 1 cm diameter. A malignancy that in the opinion of one the Principal Investigators is unlikely to present an unacceptable threat to the health of the patient by delaying standard therapy for a maximum of 4 weeks. At least 4 weeks must have elapsed since radiation, chemotherapy or major surgery. Negative urine pregnancy test in women of child-bearing potential. Patients must be able to understand the risks and benefits of the study and give written informed consent to participation.
Exclusion Criteria:
	Patients will be excluded from participating in the study if:
	Patients have uncontrolled cardiac, hepatic, renal or psychiatric disease Patients have: unacceptable renal and hepatic function evidenced by a serum creatinine ≥ 1.5 mg/dl and serum transaminase levels ≥ 3 x the upper limit of normal for the reference laboratory bilirubin > 20µmol/L inadequate hematological function defined by platelets < 100x10⁹ /L, WCC < 3x10⁹/L, Hb < 8g/dL, neutrophils < 1.5 x 10⁹/L Patients are currently taking or have received treatment with any investigational agent within the previous 4 weeks. Patients are currently taking immunosuppressive therapy (e.g. organ transplant recipients). Patients have active infection that in the opinion of the Principal Investigator is sufficiently severe to warrant exclusion. Patients are either pregnant or breast-feeding and, if of child-bearing age, are not using contraception.

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Study #NV06-0037

Multi-Center, Phase Ib/IIa Safety and Preliminary Efficacy Study of Phenoxodiol (Intravenous Dosage Form) as a Chemo-Sensitizing Agent for Cisplatin and Paclitaxel in Epithelial Ovarian Cancer or Primary Peritoneal Cancer that is Platinum- and/or Taxane-R

Site:
	Yale-New Haven Hospital, New Haven, CT, USA Royal Women's Hospital, Melbourne, VIC, AUSTRALIA
Eligibility:
	Patients with recurrent ovarian or primary peritoneal cancer that is resistant or refractory to platinum-based drugs or taxane-based drugs.
Number of patients: 60
Objectives:
	to determine the safety and tolerability of a combinational therapy of phenoxodiol and cisplatin in patients with late-stage ovarian cancer or primary peritoneal cancer; to determine the safety and tolerability of a combinational therapy of phenoxodiol and paclitaxel in patients with late-stage ovarian cancer or primary peritoneal cancer; to gain a preliminary indication of the efficacy of phenoxodiol as a chemo-sensitizing agent for paclitaxel in paclitaxel-refractory patients by comparison with a randomized control group (paclitaxel only); to gain a preliminary indication of the relative efficacies of a phenoxodiol + cisplatin regimen and a phenoxodiol + paclitaxel regimen in providing a tumor response in patients who have demonstrated refractoriness or resistance to platinum/taxane therapy.
Treatment schedule:
	Treatment cycles are 6 weeks and treatment is continuously weekly. Phenoxodiol is administered by bolus intravenous injection on two consecutive days per week at a dosage of 3 mg/kg. Cisplatin and paclitaxel are administered by intravenous injection immediately following the second phenoxodiol injection.
Outcomes:
	Tumor size CA125 levels Quality of life.
Inclusion criteria:
	Patients meeting all of the following criteria will be considered for admission to the study:
	Patients must have histological evidence of epithelial ovarian, fallopian or primary peritoneal carcinoma and have been previously surgically staged. Patients must have received no more than 4 prior chemotherapy regimens for this malignancy. Patients must have been treated previously with a taxane (paclitaxel or taxotere) and/or platinum (cisplatin or carboplatin) and be considered refractory or resistant to either or both therapies based on the following: have had a treatment-free interval following platinum or paclitaxel of less than 6 months or have progressed during platinum or paclitaxel-based therapy. Patients must have either measurable or evaluable disease by the following criteria: Measurable disease is defined as having at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded) allowing a response to be determined by the RECIST criteria. Each lesion must be ≥ 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or ≥ 10 mm when measured by spiral CT. Patients with evaluable disease must have experienced doubling of blood levels of CA125 in the six (6) months leading up to enrollment in the study and have a CA125 level at least two times greater than the institutional upper limit of normal values, within 1 week of study entry. Patients must be > 18 years of age and must be able to understand the risks and benefits of the study and to be able to give written informed consent to participation Patients must have a Karnofsky Performance Score of at least 60% Patients must be off any standard therapy directed at the malignant tumor for at least 4 weeks, and in the case of any investigational anti-cancer drugs, for at least 6 months Patients should be free of active infection requiring antibiotics Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception Patients must have; Renal function: creatinine levels = 1.5 x institutional upper limit normal (ULN) (equivalent to Common Toxicity Criteria (CTC) Grade 1) Hepatic function: bilirubin levels = 1.5 x ULN (CTC Grade 1); SGOT and alkaline phosphatase = 2.5 x ULN (CTC Grade 1) Bone marrow function: platelets > 100x10⁹/L , WCC > 3x10⁹/L, Hb > 8g/dL, neutrophils > 1.5 x 10⁹/L Neurological function: neuropathy (sensory and motor) less than or equal to CTC Grade 1. Patients must have signed an approved informed consent.
Exclusion Criteria
	Patients presenting with any of the following will not be included in the study:
	Patients who are on a concurrent investigational drug study Patients with active infection Patients with have active CNS metastases. Patients with known CNS metastases must have received prior radiation therapy, and CNS metastatic disease must be stable for 4 weeks. Patients who have not recovered from the acute effects of any prior anti-neoplastic therapy. Patients who have had whole abdominal radiation. Patients who are pregnant or breast feeding.

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Study #NV06-0039

OVArian TUmour REsponse (OVATURE) Study

Short title:
	OVATURE (OVArian TUmor REsponse) study
Site:
	The target is 60 sites: 30 in the USA, 25 in UK and Europe and 5 in Australia
Inclusion criteria:
	Tumor type: Histologically-confirmed ovarian, fallopian, or primary peritoneal carcinoma of epithelial origin Recurrent or persistent advanced disease have measurable disease by CT Treatment response history: undergone at least two courses of therapy with a platinum drug (cisplatin or carboplatin) and have responded to the first of those courses of therapy as determined by either RECIST or GCIG criteria; shown disease relapse as determined by either RECIST or GCIG criteria within 6 months of completion of the second or greater course of platinum therapy using a 2- or 3-weekly regimen and; have a platinum-free interval of no greater than 6 months at the time of enrollment, being the time taken from the last day of platinum therapy; Treatment history Can have any number of previous courses of platinum therapy or non-platinum therapy Clinical status: Be considered likely to survive at least 3 months Have a Karnofsky Performance Score of at least 60% Have adequate physiological function without evidence of major organ dysfunction as evidenced by a serum creatinine < 1.5 mg/dl, serum transaminase levels -3 x the upper limit of normal (ULN) for the reference laboratory, and a bilirubin level < ULN Have adequate hematological function defined by platelets > 100,000/ mm3, WCC > 3,000/mm3, neutrophils > 1,500 /mm3, hemoglobin> 8.0 g/dl Other: Be age > 18 Be able to understand the risks and benefits of the study and give written informed consent to participation.
Exclusion Criteria
	Patients presenting with any of the following will not be included in the study:
	patients with mucinous histological type of ovarian cancer; patients who have failed to show a clinical response (RECIST or GCIG criteria) to at least one prior course of platinum therapy Patients with active infection Patients with concurrent severe and/or uncontrolled medical disease (eg. uncontrolled diabetes, hypertension, ischemic heart disease, congestive heart failure, etc.) Patients with a history of chronic active hepatitis or cirrhosis Patients with HIV Patients with active CNS metastases. Patients with known CNS metastases must have received prior radiation therapy, and CNS metastatic disease must be stable for 4 weeks Patients who have not recovered from the acute effects of any prior anti-neoplastic therapy Patients with known hypersensitivity to platinum drugs

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Study #Yale 27640

A randomised placebo-controlled phase Ib/IIa safety, tolerability and efficacy study of oral phenoxodiol in combination with docetaxol versus docetaxol alone in patients with recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer

Short title:
	Docetaxol plus phenoxodiol versus docetaxol plus placebo in ovarian cancer
Site:
	Yale-New Haven Hospital, New Haven, CT, USA
Inclusion criteria:
	Tumor type: Histologically-confirmed epithelial ovarian, fallopian, or primary peritoneal carcinoma Recurrent disease Disease and treatment history: Undergone at least first-line therapy which must have included a platin and Taxane Eligible for second-line therapy Platin/Taxane sensitive (recurrence >6 months after first-line therapy) Experienced doubling of blood levels of CA125 in the six (6) months leading up to enrolment in the study and have CA125 levels at least two times greater than the institutional upper limit of normal values or Have measurable disease as defined as having at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded) allowing a response to be determined by the RECIST criteria. Each lesion must be > 10 mm when measured by spiral CT Clinical status: Be considered likely to survive at least 3 months Have a Karnofsky Performance Score of at least 60% Have adequate physiological function without evidence of major organ dysfunction as evidenced by a serum creatinine < 1.5 mg/dl, serum transaminase levels -3 x the upper limit of normal (ULN) for the reference laboratory, and a bilirubin level < ULN Have adequate hematological function defined by platelets > 100,000/ mm3, WCC > 3,000/mm3, neutrophils > 1,500 /mm3, hemoglobin> 8.0 g/dl Have peripheral neuropathy < grade 1 Other: Be age > 18 Be able to understand the risks and benefits of the study and give written informed consent to participation.
Exclusion Criteria
	Patients presenting with any of the following will not be included in the study:
	Patients who are on a concurrent investigational drug study or who have had any treatment with any investigational agents within 4 weeks of commencing the study Patients with active infection Patients with concurrent severe and/or uncontrolled medical disease (eg. uncontrolled diabetes, hypertension, ischemic heart disease, congestive heart failure, etc.) Patients with a history of chronic active hepatitis or cirrhosis Patients with HIV Patients with active CNS metastases. Patients with known CNS metastases must have received prior radiation therapy, and CNS metastatic disease must be stable for 4 weeks Patients who have not recovered from the acute effects of any prior anti-neoplastic therapy Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80.

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Contact Details

Marshall Edwards, Inc.
140 Wicks Road
North Ryde NSW 2113
Australia

T: +61 2 8877 6196
F: +61 2 9878 8474

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