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SGI-110 in Combination With Carboplatin in Ovarian Cancer

Information source: Astex Pharmaceuticals
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ovarian Cancer

Intervention: SGI-110 and carboplatin (Drug); Treatment of Choice ( topotecan, pegylated liposomal doxorubicin, or paclitaxel) (Drug)

Phase: Phase 1/Phase 2

Status: Active, not recruiting

Sponsored by: Astex Pharmaceuticals


A 2-part, Phase 1-2 controlled, open-label, randomized study in patients with platinum-resistant recurrent ovarian cancer. In Part 1, patients will receive SGI-110 and carboplatin. The optimum dose will be identified in Part 1 based on safety and efficacy. In Part 2, patients will be randomized to receive the dose identified in Part 1 plus carboplatin or one of three treatment of choice at the discretion of the investigator. The treatment of choice consists of topotecan, pegylated liposomal doxorubicin, or paclitaxel.

Clinical Details

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

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

Primary outcome:

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

Part 2 (Randomized, Controlled, Open Label): Assess and compare progression free survival (PFS) between SGI-110 and carboplatin and Treatment of Choice arms

Secondary outcome:

Objective response rate (complete and partial responses)

Progression free survival at 6 months

Clinical benefit rate (complete response + partial response + stable disease for at least 3 months)

CA-125 reduction

Duration of Response

Overall survival

Pharmacokinetics of combination treatment of SGI-110 and carboplatin


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.


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.

Locations and Contacts

Bristol Heamatology and Oncology Centre, Bristol BS2 8ED, United Kingdom

St. James Univesity Hospital - St. James Institute of Oncology, Leeds LS9 7TF, United Kingdom

Univesity College Hospital, London CET NW1 2PG, United Kingdom

Cambridge University Hospitals NHS Foundation and Trust, London EC1V 4AD, United Kingdom

Imperial College Health Care NHS Trust-Garry Weston Centre, London W12 0NN, United Kingdom

Mount Vernon Cancer Centre, Middlesex HA6 2RN, United Kingdom

Royal Marsden Foundation Trust, Sutton SM2 5PT, United Kingdom

Tom Baker Cancer Centre, Calgary, Alberta T2N 4N2, Canada

Norris Comprehensive Cancer Center- University of Southern California, Los Angeles, California 90033, United States

University of Florida Shands Cancer Center, Gainesville, Florida 32610, United States

Georgia Health Sciences University, Augusta, Georgia 30912, United States

University of Chicago, Chicago, Illinois 60637, United States

Melvin and Bren Simon Cancer Center- Indiana University, Indianapolis, Indiana 46202, United States

Women's Cancer Care, Covington, Louisiana 70433, United States

Johns Hopkins Kimmel Cancer Center, Baltimore, Maryland 21231, United States

Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States

Island Gynecologic Oncology, Brightwaters, New York 11718, United States

Duke Cancer Institute- Duke University Medical Center, Durham, North Carolina 27710, United States

University of Cincinnati Cancer Institute, Cincinnati, Ohio 45267, United States

Juravinski Cancer Centre, Hamilton, Ontario L8V 5C2, Canada

Princess Margaret Hospital, Toronto, Ontario M5G 2M9, Canada

CHUM Gynecologie-Oncologie, Notre Dame Hospital, Montreal, Quebec H2L 4M1, Canada

Mary Crowley Medical Research Center, Dallas, Texas 75201, United States

Inova Fairfax Hospital, Falls Church, Virginia 22042, United States

Additional Information

Starting date: September 2012
Last updated: March 5, 2015

Page last updated: August 20, 2015

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