Ovarian CancerPhase 2SGI-110NCT01696032
SGI-110 in Combination With Carboplatin in Ovarian Cancer
A Phase 2 study testing SGI-110, Treatment of Choice (topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine) and Carboplatin in people with Ovarian Cancer, run by Astex Pharmaceuticals, Inc. at 24 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- SGI-110, Treatment of Choice (topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine) and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 24 sitesin 3 countries
- Study dates
- Sep 2012to Aug 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
24 sites in 3 countries.
24 sites in 3 countries
United States13 sites
Georgia Health Sciences University
Augusta, Georgia, 30912
Johns Hopkins Kimmel Cancer Center
Baltimore, Maryland, 21231
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Island Gynecologic Oncology
Brightwaters, New York, 11718
University of Chicago
Chicago, Illinois, 60637
University of Cincinnati Cancer Institute
Cincinnati, Ohio, 45267
Women's Cancer Care
Covington, Louisiana, 70433
Mary Crowley Medical Research Center
Dallas, Texas, 75201
Duke Cancer Institute- Duke University Medical Center
Durham, North Carolina, 27710
Inova Fairfax Hospital
Falls Church, Virginia, 22042
University of Florida Shands Cancer Center
Gainesville, Florida, 32610
Melvin and Bren Simon Cancer Center- Indiana University
Indianapolis, Indiana, 46202
Norris Comprehensive Cancer Center- University of Southern California
Los Angeles, California, 90033
United Kingdom7 sites
Bristol Heamatology and Oncology Centre
Bristol, BS2 8ED
St. James Univesity Hospital - St. James Institute of Oncology
Leeds, LS9 7TF
Cambridge University Hospitals NHS Foundation and Trust
London, EC1V 4AD
Univesity College Hospital
London, NW1 2PG
Imperial College Health Care NHS Trust-Garry Weston Centre
London, W12 0NN
Mount Vernon Cancer Centre
Middlesex, HA6 2RN
Royal Marsden Foundation Trust
Sutton, SM2 5PT
Canada4 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
CHUM Gynecologie-Oncologie, Notre Dame Hospital
Montreal, Quebec, H2L 4M1
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: A Randomized, Controlled, Open-Label, Phase 2 Trial of SGI-110 and Carboplatin in Subjects With Platinum-Resistant Recurrent Ovarian Cancer
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.
- Conditions
- Ovarian Cancer
- Being tested
- SGI-110, Treatment of Choice (topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine), Carboplatin
- Keywords
- Ovarian Cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGI-110Drug
Also called guadecitabine
Treatment of Choice (topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine)Drug
Investigator chose to treat with either topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine
CarboplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| SGI-110 + Carboplatin | Experimental | Stage 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. Receives: Drug: SGI-110; Drug: Carboplatin |
| SGI-110 + Carboplatin or TC | Experimental | Stage 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. Receives: Drug: SGI-110; Drug: Treatment of Choice (topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine); Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage 1: Dose Limiting Toxicities
Number of participants with dose limiting toxicities (DLTs) in Stage 1
Measured: 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.
Measured: Up to 24 months
Secondary outcomes (9)
Objective Response Rate
The objective response rate (ORR) was defined as the proportion of participants who experienced an objective response (best overall response of complete response/full response or partial response, which was confirmed by a subsequent assessment at least 28 days later). Response categories were determined based on RECIST v1.1 criteria, or on modified Rustin (CA-125) criteria if response assessment could not be made using RECIST criteria.
Measured: Up to 24 months
Progression Free Survival at 6 Months
Progression free survival rate at 6 months is the proportion of participants who were alive and did not have disease progression at 6 months after start of treatment.
Measured: 6 months
Clinical Benefit Rate
Clinical benefit rate (CBR) was defined as the proportion of subjects who experienced a best overall response of complete response/full response or partial response (confirmed by a subsequent assessment at least 28 days later), or documented stable disease for at least 3 months after the first dose. Response categories were determined based on RECIST v1.1 criteria, then based on modified Rustin (CA-125) criteria if assessment could not be made using RECIST criteria.
Measured: Up to 24 months
CA-125 Levels
Percentage of participants with CA-125 reduction by ≥ 50% from baseline
Measured: Up to 24 months
Duration of Response
Duration of response is defined as the time between the date of the first documentation of complete response/full response or partial response, and the date of disease progression or date of death due to any cause, or the last adequate tumor assessment prior to the start of subsequent anti-cancer therapy including crossing over to G+C from TC arm, whichever occurred earlier. Only participants who responded were included in the duration of response calculation.
Measured: Up to 24 months
Overall Survival
Overall survival was defined as the number of days from the day the participant was administered the first dose of study treatment to the date of death (regardless of cause). Survival time was censored on the last date the participant was known to be alive or lost to follow-up before reaching the event of death; in the TC group, time was censored at the date of crossover.
Measured: Up to 24 months
Stage 1: Pharmacokinetic Parameter Cmax
Time to maximum plasma concentration for guadecitabine, decitabine and carboplatin
Measured: Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)
Stage 1: Pharmacokinetic Parameter Tmax
Time to last measurable concentration for guadecitabine, decitabine and carboplatin
Measured: Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)
Stage 1: Pharmacokinetic Parameter AUC0-8
Area under the concentration-time curve from 0 to 8 hours (AUC0-8) for guadecitabine, decitabine and carboplatin
Measured: Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astex Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696032
- Sponsor's protocol ID
- SGI-110-02
- Acronym
- SGI-110
- Status last verified
- Jul 2024
- First submitted
- 26 Sep 2012
- Last updated
- 27 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 33289590Oza 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.
PubMed 31831561
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-Label, Phase 2 Trial of SGI-110 and Carboplatin in Subjects With Platinum-Resistant Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT01696032
- Acronym / sponsor ID
- SGI-110 / SGI-110-02
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Astex Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 28 Sep 2012 (estimated)
- Results
- Posted 25 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGI-110 + Carboplatin | Experimental | Drug: SGI-110, Drug: CarboplatinStage 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 | Experimental | Drug: SGI-110, Drug: Treatment of Choice (topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine), Drug: CarboplatinStage 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGI-110Also: guadecitabine | Drug | SGI-110 + Carboplatin, SGI-110 + Carboplatin or TC |
| Treatment of Choice (topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine)Investigator chose to treat with either topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine | Drug | SGI-110 + Carboplatin or TC |
| Carboplatin | Drug | SGI-110 + Carboplatin, SGI-110 + Carboplatin or TC |
Primary outcome
Stage 1: Dose Limiting Toxicities
Time frame: Up to 12 months
Number of participants with dose limiting toxicities (DLTs) in Stage 1
Stage 2: Progression Free Survival
Time frame: Up to 24 months
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.
9 secondary outcomes
Objective Response Rate
Time frame: Up to 24 months
Progression Free Survival at 6 Months
Time frame: 6 months
Clinical Benefit Rate
Time frame: Up to 24 months
CA-125 Levels
Time frame: Up to 24 months
Duration of Response
Time frame: Up to 24 months
Overall Survival
Time frame: Up to 24 months
Stage 1: Pharmacokinetic Parameter Cmax
Time frame: Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)
Stage 1: Pharmacokinetic Parameter Tmax
Time frame: Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)
Stage 1: Pharmacokinetic Parameter AUC0-8
Time frame: Pre-dose and up to 8 hours post-dose on Cycle 1 Day 1 for guadecitabine and decitabine and Day 8 for carboplatin (28 day cycles)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33289590Cardenas 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.
- Derived from this study: PubMed 31831561Oza 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SGI-110, Treatment of Choice (topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine) and Carboplatin in people with Ovarian Cancer, run by Astex Pharmaceuticals, Inc. at 24 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, United Kingdom, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage 1: Dose Limiting Toxicities (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01696032, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.