SGI-110 in Combination With Carboplatin in Ovarian Cancer
SGI-110
A Randomized, Controlled, Open-Label, Phase 2 Trial of SGI-110 and Carboplatin in Subjects With Platinum-Resistant Recurrent Ovarian Cancer
1 other identifier
interventional
120
3 countries
24
Brief Summary
A 2-part, Phase 2 controlled, open-label, randomized study in participants with platinum-resistant recurrent ovarian cancer. In Part 1, participants received SGI-110 and carboplatin. The optimum dose of SGI-110 (guadecitabine) was identified in Part 1 based on safety and efficacy. In Part 2, participants were randomized to receive the dose identified in Part 1 plus carboplatin or one of four treatment of choice at the discretion of the investigator. The treatment of choice consisted of topotecan, pegylated liposomal doxorubicin, paclitaxel or gemcitabine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 ovarian-cancer
Started Sep 2012
Typical duration for phase_2 ovarian-cancer
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 26, 2012
CompletedFirst Posted
Study publicly available on registry
September 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
May 25, 2021
CompletedAugust 27, 2024
July 1, 2024
3.9 years
September 26, 2012
April 30, 2021
July 31, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Stage 1: Dose Limiting Toxicities
Number of participants with dose limiting toxicities (DLTs) in Stage 1
Up to 12 months
Stage 2: Progression Free Survival
Progression free survival (PFS) time was defined as the time interval from the date of the first dose of study medication until the earlier of disease progression or death. Participants were treated with their assigned treatment \[guadecitabine+carboplatin (G+C) or treatment choice (TC)\] until disease progression or unacceptable treatment-related toxicity occurred.
Up to 24 months
Secondary Outcomes (9)
Objective Response Rate
Up to 24 months
Progression Free Survival at 6 Months
6 months
Clinical Benefit Rate
Up to 24 months
CA-125 Levels
Up to 24 months
Duration of Response
Up to 24 months
- +4 more secondary outcomes
Study Arms (2)
SGI-110 + Carboplatin
EXPERIMENTALStage 1 was a safety lead-in stage with a dose escalation design. Participants were evaluated with the combination of SGI-110 (guadecitabine) plus carboplatin (G+C), given as 28-day treatment cycles: guadecitabine administered subcutaneous (SC) daily on Days 1-5, at a starting dose of 45 mg/m2/day in Cohort 1, followed by carboplatin intravenous (IV) based on a targeted dose of area under the curve (AUC) 5 on Day 8. After dose limiting toxicities were noted, guadecitabine dose was reduced to 30 mg/m2/day for subsequent cycles for 4 participants. Cohort 2 received 30 mg/m2/day guadecitabine and carboplatin IV AUC 4.
SGI-110 + Carboplatin or TC
EXPERIMENTALStage 2 was an open-label, randomized, controlled trial. Eligible participants were randomly assigned in a 1:1 ratio to receive either (1) G+C combination treatment in 28-day cycles at 30 mg/m2 SC once daily on Days 1-5 and carboplatin IV AUC 4 on Day 8, or (2) treatment of choice (TC) of topotecan, pegylated liposomal doxorubicin (PLD), paclitaxel, or gemcitabine based on recommended dosing in 28-day cycles; participants initially randomized to TC were able to cross over to receive 30 mg/m2 G+C due to disease progression.
Interventions
Investigator chose to treat with either topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine
Eligibility Criteria
You may qualify if:
- Participants who are women 18 years of age or older.
- Participants who have histologically or cytologically confirmed recurrent high-grade serous epithelial ovarian cancer (Grade 2 or 3), primary peritoneal carcinomatosis or fallopian tube cancer.
- Participants 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, participants may have had no more than 3 prior cytotoxic treatment regimens, excluding adjuvant or maintenance therapy.
- Participants must have had prior paclitaxel treatment.
- Participants who have measurable disease according to RECIST v1.1 or detectable disease.
- Participants with ECOG performance status of 0 or 1.
- Participants with acceptable organ function.
- Participants must be at least 3 weeks from last chemotherapy.
You may not qualify if:
- Participants who have hypersensitivity to SGI-110 and/or carboplatin or other components of these drug products.
- Participants who have received prior therapy with any hypomethylating agents.
- Participants who are refractory to platinum treatment i.e., progressed while on platinum treatment.
- Participants with abnormal left ventricular ejection fraction.
- Participants with Grade 2 or greater neuropathy.
- Participants with known brain metastases.
- Participants with known history of HIV, HCV or HBV.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
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
Mary Crowley Medical Research Center
Dallas, Texas, 75201, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
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
Bristol Heamatology and Oncology Centre
Bristol, BS2 8ED, United Kingdom
St. James Univesity Hospital - St. James Institute of Oncology
Leeds, LS9 7TF, United Kingdom
Cambridge University Hospitals NHS Foundation and Trust
London, EC1V 4AD, United Kingdom
Univesity College Hospital
London, NW1 2PG, 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
Related Publications (2)
Cardenas H, Fang F, Jiang G, Perkins SM, Zhang C, Emerson RE, Hutchins G, Keer HN, Liu Y, Matei D, Nephew K. Methylomic Signatures of High Grade Serous Ovarian Cancer. Epigenetics. 2021 Nov;16(11):1201-1216. doi: 10.1080/15592294.2020.1853402. Epub 2020 Dec 8.
PMID: 33289590DERIVEDOza AM, Matulonis UA, Alvarez Secord A, Nemunaitis J, Roman LD, Blagden SP, Banerjee S, McGuire WP, Ghamande S, Birrer MJ, Fleming GF, Markham MJ, Hirte HW, Provencher DM, Basu B, Kristeleit R, Armstrong DK, Schwartz B, Braly P, Hall GD, Nephew KP, Jueliger S, Oganesian A, Naim S, Hao Y, Keer H, Azab M, Matei D. A Randomized Phase II Trial of Epigenetic Priming with Guadecitabine and Carboplatin in Platinum-resistant, Recurrent Ovarian Cancer. Clin Cancer Res. 2020 Mar 1;26(5):1009-1016. doi: 10.1158/1078-0432.CCR-19-1638. Epub 2019 Dec 12.
PMID: 31831561DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Taiho Central
- Organization
- Taiho Oncology, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
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
September 26, 2012
First Posted
September 28, 2012
Study Start
September 1, 2012
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
August 27, 2024
Results First Posted
May 25, 2021
Record last verified: 2024-07