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SGI-110 in Combination With Carboplatin in Ovarian Cancer (SGI-110)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01696032
Recruitment Status : Completed
First Posted : September 28, 2012
Last Update Posted : January 18, 2020
Information provided by (Responsible Party):
Astex Pharmaceuticals, Inc.

Brief Summary:
A 2-part, Phase 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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: SGI-110 Drug: Treatment of Choice ( topotecan, pegylated liposomal doxorubicin, or paclitaxel) Drug: Carboplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Open-Label, Phase 2 Trial of SGI-110 and Carboplatin in Subjects With Platinum-Resistant Recurrent Ovarian Cancer
Study Start Date : September 2012
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Arm Intervention/treatment
Experimental: SGI-110 + Carboplatin
Part 1: Patients will be dosed with SGI-110 and carboplatin
Drug: SGI-110
Other Name: guadecitabine

Drug: Carboplatin
Experimental: SGI-110 + carboplatin or TC
Part 2: Patients will be randomized to receive SGI-110 and carboplatin or Treatment of Choice (TC). TC is at the discretion of the investigator and can be one of three standard of care treatments (topotecan, paclitaxel or pegylated liposomal doxorubicin).
Drug: SGI-110
Other Name: guadecitabine

Drug: Treatment of Choice ( topotecan, pegylated liposomal doxorubicin, or paclitaxel)
Investigator may choose to treat with either topotecan, pegylated liposomal doxorubicin, or paclitaxel

Drug: Carboplatin

Primary Outcome Measures :
  1. 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 [ Time Frame: 9 months ]

    Number of patients with adverse events

    Incidence of dose limiting toxicities

  2. Part 2 (Randomized, Controlled, Open Label): Assess and compare progression free survival (PFS) between SGI-110 and carboplatin and Treatment of Choice arms [ Time Frame: 12 months ]

    Change in CA-125 tumor biomarker every 4 weeks

    Change in tumor measurements by RECIST 1.1 every 8 weeks

Secondary Outcome Measures :
  1. Objective response rate (complete and partial responses) [ Time Frame: 12 months ]
    Clinical responses based both on measurable disease and detectable disease

  2. Progression free survival at 6 months [ Time Frame: 12 months ]
    Assessment of progression free survival as measured by weeks

  3. Clinical benefit rate (complete response + partial response + stable disease for at least 3 months) [ Time Frame: 12 months ]
    Assessment of clinical benefit rate as measured by weeks

  4. CA-125 reduction [ Time Frame: 12 months ]
    Percentage of patients with CA-125 reduction by ≥ 50%

  5. Duration of Response [ Time Frame: 12 months ]
    Duration of response measured in weeks

  6. Overall survival [ Time Frame: 12 months ]
    Overall survival measured in weeks

  7. Pharmacokinetics of combination treatment of SGI-110 and carboplatin [ Time Frame: 12 months ]
    Cmax, Cmin, AUC and other secondary PK parameters of SGI-110, decitabine and carboplatin in all patients during Cycle 1

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01696032

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Sponsors and Collaborators
Astex Pharmaceuticals, Inc.

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Responsible Party: Astex Pharmaceuticals, Inc. Identifier: NCT01696032    
Other Study ID Numbers: SGI-110-02
First Posted: September 28, 2012    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Keywords provided by Astex Pharmaceuticals, Inc.:
Ovarian Cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Albumin-Bound Paclitaxel
Liposomal doxorubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic