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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.
 
ClinicalTrials.gov Identifier: NCT01696032
Recruitment Status : Completed
First Posted : September 28, 2012
Last Update Posted : January 18, 2020
Sponsor:
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

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

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 ClinicalTrials.gov identifier (NCT number): NCT01696032


Locations
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United States, California
Norris Comprehensive Cancer Center- University of Southern California
Los Angeles, California, United States, 90033
United States, Florida
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610
United States, Georgia
Georgia Health Sciences University
Augusta, Georgia, United States, 30912
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Indiana
Melvin and Bren Simon Cancer Center- Indiana University
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Women's Cancer Care
Covington, Louisiana, United States, 70433
United States, Maryland
Johns Hopkins Kimmel Cancer Center
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Island Gynecologic Oncology
Brightwaters, New York, United States, 11718
United States, North Carolina
Duke Cancer Institute- Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
University of Cincinnati Cancer Institute
Cincinnati, Ohio, United States, 45267
United States, Texas
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75201
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
CHUM Gynecologie-Oncologie, Notre Dame Hospital
Montreal, Quebec, Canada, H2L 4M1
United Kingdom
Bristol Heamatology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
St. James Univesity Hospital - St. James Institute of Oncology
Leeds, United Kingdom, LS9 7TF
Cambridge University Hospitals NHS Foundation and Trust
London, United Kingdom, EC1V 4AD
Univesity College Hospital
London, United Kingdom, NW1 2PG
Imperial College Health Care NHS Trust-Garry Weston Centre
London, United Kingdom, W12 0NN
Mount Vernon Cancer Centre
Middlesex, United Kingdom, HA6 2RN
Royal Marsden Foundation Trust
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
Astex Pharmaceuticals, Inc.

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Responsible Party: Astex Pharmaceuticals, Inc.
ClinicalTrials.gov 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
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Doxorubicin
Liposomal doxorubicin
Topotecan
Guadecitabine
Azacitidine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic