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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.

Tracking Information
First Submitted Date  ICMJE September 26, 2012
First Posted Date  ICMJE September 28, 2012
Last Update Posted Date January 18, 2020
Study Start Date  ICMJE September 2012
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2012)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01696032 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2012)
  • Objective response rate (complete and partial responses) [ Time Frame: 12 months ]
    Clinical responses based both on measurable disease and detectable disease
  • Progression free survival at 6 months [ Time Frame: 12 months ]
    Assessment of progression free survival as measured by weeks
  • 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
  • CA-125 reduction [ Time Frame: 12 months ]
    Percentage of patients with CA-125 reduction by ≥ 50%
  • Duration of Response [ Time Frame: 12 months ]
    Duration of response measured in weeks
  • Overall survival [ Time Frame: 12 months ]
    Overall survival measured in weeks
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SGI-110 in Combination With Carboplatin in Ovarian Cancer
Official Title  ICMJE A Randomized, Controlled, Open-Label, Phase 2 Trial of SGI-110 and Carboplatin in Subjects With Platinum-Resistant Recurrent Ovarian Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: SGI-110 + Carboplatin
    Part 1: Patients will be dosed with SGI-110 and carboplatin
    Interventions:
    • Drug: SGI-110
    • 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).
    Interventions:
    • Drug: SGI-110
    • Drug: Treatment of Choice ( topotecan, pegylated liposomal doxorubicin, or paclitaxel)
    • Drug: Carboplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 15, 2018)
120
Original Estimated Enrollment  ICMJE
 (submitted: September 27, 2012)
116
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01696032
Other Study ID Numbers  ICMJE SGI-110-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Astex Pharmaceuticals, Inc.
Study Sponsor  ICMJE Astex Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Astex Pharmaceuticals, Inc.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP