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Completed

NCT Number: NCT01696032

SGI-110 in Combination With Carboplatin in 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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Tom Baker Cancer Centre, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

SGI-110

Drug

Other names: 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

carboplatin

Drug

Primary outcomes

  1. Stage 1: Dose Limiting Toxicities

    Time frame: Up to 12 months

    Number of participants with dose limiting toxicities (DLTs) in Stage 1

  2. 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.

Secondary outcomes

  1. Objective Response Rate

    Time frame: Up to 24 months

    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.

  2. Progression Free Survival at 6 Months

    Time frame: 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.

  3. Clinical Benefit Rate

    Time frame: Up to 24 months

    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.

  4. CA-125 Levels

    Time frame: Up to 24 months

    Percentage of participants with CA-125 reduction by ≥ 50% from baseline

  5. Duration of Response

    Time frame: Up to 24 months

    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.

  6. Overall Survival

    Time frame: Up to 24 months

    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.

  7. 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)

    Time to maximum plasma concentration for guadecitabine, decitabine and carboplatin

  8. 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)

    Time to last measurable concentration for guadecitabine, decitabine and carboplatin

  9. 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)

    Area under the concentration-time curve from 0 to 8 hours (AUC0-8) for guadecitabine, decitabine and carboplatin

Sponsors and collaborators

Lead sponsor

Astex Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Acronym: SGI-110

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Sep 28, 2012
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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