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phenoxodiol

Phase 3

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

Success Probability

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Market & Valuation

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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 CancerUnlock 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
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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.
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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
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Frequently asked questions about phenoxodiol

What is Phenoxodiol used for?

Phenoxodiol is an investigational small molecule being studied for the treatment of prostate cancer and fallopian tube cancer. It is developed by Lite Strategy, Inc. (ticker: LITS). The drug is currently in Phase 2 clinical development for these oncology indications.

How does Phenoxodiol work?

Phenoxodiol is a small molecule therapeutic agent. Its mechanism of action involves targeting cancer cells, though the specific molecular target has not been disclosed. It is being evaluated for its potential to treat prostate cancer and fallopian tube cancer.

Who makes Phenoxodiol?

Phenoxodiol is developed by Lite Strategy, Inc., a biopharmaceutical company traded under the ticker symbol LITS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in oncology indications.

What phase is Phenoxodiol in?

Phenoxodiol is currently in Phase 2 clinical development. It has completed two clinical trials, including a Phase 1 and a Phase 3 study, with a total enrollment of 207 participants. The drug is investigational and not yet approved by regulatory authorities.

What clinical trials is Phenoxodiol in?

Phenoxodiol has completed two clinical trials. NCT00091377 was a Phase 1 study combining phenoxodiol with cisplatin or paclitaxel in patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. NCT00382811 was a Phase 3 study of weekly carboplatin with or without phenoxodiol in platinum-resistant ovarian cancer. Both trials are completed.

Is Phenoxodiol the same as other drugs?

Phenoxodiol is also known by its chemical name, 2H-1-benzopyran-7-ol, 3-(4-hydroxyphenyl)-. It is being studied under this name in clinical trials for prostate cancer and fallopian tube cancer. No other alternative names have been reported.