Recent Updates
Recently added Catalysts

phenoxodiol

Phase 3

Fallopian Tube Cancer | Small molecule | Oncology |Lite Strategy, Inc.|Last Updated: Jul 18, 2016

Success Probability
Subscribe to view
Market & Valuation
Subscribe to view
Trial Design
RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment207
FDA Designations
No designations recorded
Clinical trial landscape

phenoxodiol · 3 trials · 5 indications

Phase 3 1Phase 2 1Phase 1 1
NCT00382811OVATURE (OVArian TUmor REsponse) A Phase III Study of Weekly Carboplatin With and Without Phenoxodiol in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian CancerFallopian Tube Cancer
COMPLETED142 Analytics
PHASE3COMPLETED
OVATURE (OVArian TUmor REsponse) A Phase III Study of Weekly Carboplatin With and Without Phenoxodiol in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian Cancer
Fallopian Tube Cancer
NCT00382811142
Unlock trial analytics
Study Endpoints
Primary Endpoints
The primary efficacy end-point is progression-free survival (PFS). PFS is the time from randomization until disease progression or death
Progression Free Survival
The proportion of patients that have a 50% post-therapy PSA decline at 12 weeks in patients with: a)Chemotherapy naïve androgen independent disease (Group A) b)Rising PSA after radical prostatectomy or radiotherapy that are androgen dependent (Group B)
12 weeks
Safety and tolerability
Average 6 mo
Efficacy
Average 6 months
Secondary Endpoints
The secondary efficacy end-point is overall survival (OS)
Overall survival
To determine the proportion of patients treated with Phenoxodiol that has measurable disease regression at 12 weeks in patients with chemotherapy naïve androgen independent disease.
12 weeks
Surrogate marker of tumor response in terms of plasma protein tNOX
Average 6 months
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALDaily Phenoxodiol + weekly carboplatin
2ACTIVE_COMPARATORDaily phenoxodiol placebo + weekly carboplatin
AEXPERIMENTALPatients with chemotherapy naïve androgen independent disease
BEXPERIMENTALPatients with rising PSA after radical prostatectomy or radiotherapy that are androgen dependent
Arm AEXPERIMENTALPhenoxodiol IV 3 mg/kg combined with cisplatin 40 mg/m2 on Day 2 6 week cycles
Arm BEXPERIMENTALPhenoxodiol IV 3 mg/kg combined with paclitaxel 80 mg/m2 on Day 2 6 week cycles
Interventions
NameTypeDescription
phenoxodiolDRUG400mg phenoxodiol three times daily in 28 day cycles.
carboplatinDRUGAUC=2 weekly in 28 day cycles
placeboDRUGevery 8 hours daily in 28 day cycles
cisplatinDRUGIV 40 mg/m2 on Day 2 Number of Cycles: until progression or unacceptable toxicity or other withdrawal criteria are met.
paclitaxelDRUGIV 80 mg/m2 on Day 2 Number of Cycles: until progression or unacceptable toxicity or other withdrawal criteria are met.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites70

Inclusion Criteria: * Histologically-confirmed ovarian, fallopian, or primary peritoneal carcinoma of epithelial origin * Recurrent or persistent advanced disease * Have measurable disease * Undergone at least two courses of therapy with a platinum drug (cisplatin or carboplatin) and have responded...

Countries:United StatesAustraliaBelgiumItalyPolandSpainUnited Kingdom
Unlock Eligibility Criteria