EP-100 Plus Paclitaxel Versus Paclitaxel Alone in Patients With Ovarian Cancer

NCT01485848 | Completed Phase 2

• 2 other identifiers: ACT12601U1111-1124-2062
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 15

Brief Summary

Primary Objectives: o Run-in Phase: Determine a dose of EP-100 at which the initial benefit/risk of paclitaxel combined with EP-100 can be studied. o Randomized Phase: Compare the anti-tumor effects of EP-100 combined with weekly paclitaxel versus paclitaxel alone in patients with ovarian cancer. Secondary Objectives: o Randomized Phase: Quantify any significant changes in the safety profile of weekly paclitaxel alone compared to the doublet combination of paclitaxel with EP-100. o Determine an initial benefit/risk profile for this new drug combination.

Conditions

Ovarian Cancer Recurrent

Outcome Measures

Primary Outcomes (2)

• Number of patients with dose limiting toxicities (DLTs) at different doses

  Up to 30 weeks

• Overall Response Rate (ORR)

  Up to 30 weeks

Secondary Outcomes (5)

• Time to Progression (TTP) - Time

  Up to 18 months

• Progression-free Survival - Time

  Up to 18 months

• Overall Survival (OS) - Time

  Up to 18 months

• Duration of Response - Time

  Up to 18 months

• Number of Participants with Adverse Events

  Up to 18 months

Study Arms (2)

Paclitaxel

ACTIVE COMPARATOR

A single 1 hour intravenous infusion every week for 6 cycles (each cycle is 4 weeks)

Drug: EP-100

Paclitaxel + EP-100

EXPERIMENTAL

Paclitaxel every week plus EP-100 twice weekly by 1 hour intravenous infusion for the first 3 weeks of each 4 week cycle for 6 cycles (each cycle is 4 weeks)

Drug: Paclitaxel

Interventions

EP-100 DRUG

Pharmaceutical form:Solution Route of administration: Intravenous

Paclitaxel

Paclitaxel DRUG

Pharmaceutical form:Solution Route of administration: Intravenous

Paclitaxel + EP-100

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with histologically confirmed epithelial ovarian carcinomas; these will include primary peritoneal and fallopian tube carcinomas. Patient's tumor shown to be positive for the LHRH-receptors by standardized immunocytochemistry performed at the study's central laboratory.
• Reliable cancer treatment history documenting advanced disease in patients who have progressed during or recurred after treatment with a paclitaxel and/or platinum regimen for advanced disease.
• Evaluable disease based on criteria of the Gynecologic Intergroup Response Evaluation Criteria in in Solid Tumors.
• Karnofsky performance status \>/= 70%.

You may not qualify if:

• Significant cardiac disease.
• Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
• Pregnant or nursing women.
• Treatment with radiation therapy or investigational therapy within 4 weeks prior to Day 1. Had received chemotherapy prior to study entry equivalent to 3 to 5 half-lives of that chemotherapy agent or 4 weeks prior to study entry (whichever is shorter) with resolution of any side effects from that previous therapy (6 weeks for nitrosoureas or Mitomycin C.)
• Subjects with known central nervous system (CNS) metastases, either previously treated or current.
• Disease-free and off therapy for any other cancer within 5 years, except for adequately treated basal cell or squamous cell skin cancer or cervical intraepithelial neoplasia (CIN).
• Had major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1. o Had minor surgery (superficial incisions unlikely to obscure bleeding or infections) within 2 weeks prior to Day 1.
• Potentially life-threatening disease (hypercalcemia, spinal cord compression) whose disease may progress acutely during therapy.
• Unwilling or unable to comply with procedures required in this protocol.
• Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
• Susceptibility to histamine release.
• Chronic treatment with corticosteroids.
• Baseline QTc exceeding 450 msec (by Bazett's formula) and/or patients receiving class 1A or class III antiarrythmic agents.
• Serious nonmalignant disease.
• Subjects who are currently receiving any other investigational agent.

Sponsors & Collaborators

• Esperance Pharmaceuticals Inc: lead

Study Sites (15)

Investigational Site Number 840001

Greenbrae, California, 94904-2011, United States

Location

Investigational Site Number 840005

San Francisco, California, 94115, United States

Location

Investigational Site Number 840007

Louisville, Kentucky, 40202, United States

Location

Investigational Site Number 840010

Covington, Louisiana, 70433, United States

Location

Investigational Site Number 840011

Shreveport, Louisiana, 71103, United States

Location

Investigational Site Number 840503

Bozeman, Montana, 58715, United States

Location

Investigational Site Number 840004

Middletown, Ohio, 45042, United States

Location

Investigational Site Number 840008

Portland, Oregon, 97227-1191, United States

Location

Investigational Site Number 840006

Houston, Texas, 77030, United States

Location

Investigational Site Number 840603

Kennewick, Washington, 99336, United States

Location

Investigational Site Number 840103

Mount Vernon, Washington, 98273, United States

Location

Investigational Site Number 840403

Seattle, Washington, 98112, United States

Location

Investigational Site Number 840003

Seattle, Washington, 98115, United States

Location

Investigational Site Number 840303

Tacoma, Washington, 98415-0299, United States

Location

Investigational Site Number 840203

Wenatchee, Washington, 98801, United States

Location

MeSH Terms

Interventions

EP-100 membrane-disrupting peptide; Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2011
• First Posted: December 6, 2011
• Study Start: February 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 10, 2014

Record last verified: 2014-06

Locations

US (15)