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A Phase II Multi-Center Randomized, Double-Blind, Placebo-Controlled Study of Maintenance IT-101 in Platinum Sensitive Ovarian Cancer Patients Who Received 4-6 Cycles of a 2nd Line Platinum-Based Regimen Without Disease Progression.


Phase 2
18 Years
78 Years
Not Enrolling
Female
Cancer, Ovarian Cancer, Solid Tumor

Thank you

Trial Information

A Phase II Multi-Center Randomized, Double-Blind, Placebo-Controlled Study of Maintenance IT-101 in Platinum Sensitive Ovarian Cancer Patients Who Received 4-6 Cycles of a 2nd Line Platinum-Based Regimen Without Disease Progression.


Key

Inclusion Criteria:



- Women between the age of 18 and 78, inclusive;

- Evidence of platinum-sensitive ovarian cancer following the patient's primary
treatment(>= 6 months);

- Received a 2nd line platinum-based chemotherapy regimen (4-6 cycles) without evidence
of progression;

- May have measurable or unmeasurable disease;

- ECOG 0 or 1;

- Ability to understand and the willingness to sign a written informed consent
document.

Key Exclusion Criteria:

- Women who are pregnant or lactating;

- Prior treatment with a topoisomerase inhibitor;

- Patients with unacceptable organ and/or hematologic reserve at screening;

- Urine protein of > 500 mg/day or active nephropathy;

- Electrocardiogram (ECG) with evidence of clinically significant conduction
abnormalities or active ischemia as determined by the investigator;

- History of pancreatitis within the last 12 months;

- Patients treated with previous high dose chemotherapy or stem cell transplant within
the last 5 years;

- Use of any investigational agents within 4 weeks of study enrollment;

- Uncontrolled intercurrent illness, including but not limited to, ongoing or active
infection, psychiatric illness or other co-morbidity that presents a risk to the
patient as determined by the investigator.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

To Compare the proportion of patients without evidence of disease progression at 30 weeks following randomization between IT-101 at 12 mg/m2/dose or 15 mg/m2/dose to a placebo infusion treatment administered every other week.

Outcome Time Frame:

30 weeks

Safety Issue:

No

Principal Investigator

Jonathan S Berek, MD, MMS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Professor and Chair, Department of Obstetrics and Gynecology Stanford University School of Medicine Stanford Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

ID OVAR0801

NCT ID:

NCT01565421

Start Date:

September 2008

Completion Date:

May 2010

Related Keywords:

  • Cancer
  • Ovarian Cancer
  • Solid Tumor
  • Cancer
  • Neoplasms
  • Solid Tumor
  • Ovarian Cancer
  • Solid Malignancies
  • Ovarian Neoplasms

Name

Location

Gabrail Cancer CenterCanton, Ohio  44718
The Methodist HospitalHouston, Texas  77030
Chattanooga GYN OncologyChattanooga, Tennessee  37403
University of Minnesota Medical CenterMinneapolis, Minnesota  55455
Decatur Memorial Hospital, Clinical Research Department/ Cancer Care Specialists of IllinoisDecatur, Illinois  62526
Schwartz Gynecologic Onclology, PLLCBrightwaters, New York  11718
Riverside Gynecology & OncologyNewport News, Virginia  23601