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A Randomized, Controlled, Open-Label, Phase 2 Trial of SGI-110 and Carboplatin in Subjects With Platinum-Resistant Recurrent Ovarian Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer

Thank you

Trial Information

A Randomized, Controlled, Open-Label, Phase 2 Trial of SGI-110 and Carboplatin in Subjects With Platinum-Resistant Recurrent Ovarian Cancer


Inclusion Criteria:



1. Patients who are women 18 years of age or older.

2. Patients who have histologically or cytologically confirmed recurrent high-grade
serous epithelial ovarian cancer (Grade 2 or 3), primary peritoneal carcinomatosis or
fallopian tube cancer.

3. Patients who have platinum-resistant disease (defined as having relapsed within 6
months of her last platinum-containing regimen). There is no limit on the number of
prior treatment regimens in Part 1. In Part 2, patients may have had no more than 3
prior cytotoxic treatment regimens, excluding adjuvant or maintenance therapy.

4. Patients must have had prior paclitaxel treatment.

5. Patients who have measurable disease according to RECIST v1.1 or detectable disease.

6. Patients with ECOG performance status of 0 or 1.

7. Patients with acceptable organ function.

8. Patients must be at least 3 weeks from last chemotherapy.

Exclusion Criteria:

1. Patients who have hypersensitivity to SGI-110 and/or carboplatin or other components
of these drug products.

2. Patients who have received prior therapy with any hypomethylating agents.

3. Patients who are refractory to platinum treatment i.e., progressed while on platinum
treatment.

4. Patients with abnormal left ventricular ejection fraction.

5. Patients with Grade 2 or greater neuropathy.

6. Patients with known brain metastases.

7. Patients with known history of HIV, HCV or HBV.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Part 1 (Safety Lead-In): Assess the safety and tolerability of SGI-110 and carboplatin by the incidence of dose limiting toxicities and other adverse events to determine the maximum tolerated dose for Part 2

Outcome Description:

Number of patients with adverse events Incidence of dose limiting toxicities

Outcome Time Frame:

9 months

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

SGI-110-02

NCT ID:

NCT01696032

Start Date:

September 2012

Completion Date:

July 2014

Related Keywords:

  • Ovarian Cancer
  • Ovarian Cancer
  • Ovarian Neoplasms

Name

Location

Inova Fairfax HospitalFalls Church, Virginia  22042-3300
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Mary Crowley Medical Research CenterDallas, Texas  75246
Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of ChicagoChicago, Illinois  60637
Johns Hopkins Kimmel Cancer CenterBaltimore, Maryland  21231-1000
Georgia Health Sciences UniversityAugusta, Georgia  30912
Island Gynecologic OncologyBrightwaters, New York  11718
Women's Cancer CareCovington, Louisiana  70433
Norris Comprehensive Cancer Center- University of Southern CaliforniaLos Angeles, California  90033
Cedars Sinai Medical Center - Samuel Oschin Comprehensive Cancer UnitLos Angeles, California  90048
Melvin and Bren Simon Cancer Center- Indiana UniversityIndianapolis, Indiana  46202
Duke Cancer Institute- Duke University Medical CenterDurham, North Carolina  27710