SGI-110 in Combination With Carboplatin in Ovarian Cancer - Full Text View

Purpose

A 2-part, Phase 1-2 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	Intervention	Phase
Ovarian Cancer	Drug: SGI-110 and carboplatin Drug: Treatment of Choice ( topotecan, pegylated liposomal doxorubicin, or paclitaxel)	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Paclitaxel Carboplatin Topotecan hydrochloride Topotecan

U.S. FDA Resources

Further study details as provided by Astex Pharmaceuticals:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
Change in CA-125 tumor biomarker every 4 weeks

Change in tumor measurements by RECIST 1.1 every 8 weeks

Secondary Outcome Measures:

Objective response rate (complete and partial responses) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Clinical responses based both on measurable disease and detectable disease
Progression free survival at 6 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Assessment of clinical benefit rate as measured by weeks
CA-125 reduction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Percentage of patients with CA-125 reduction by ≥ 50%
Duration of Response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Duration of response measured in weeks
Overall survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Overall survival measured in weeks
Pharmacokinetics of combination treatment of SGI-110 and carboplatin [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Cmax, Cmin, AUC and other secondary PK parameters of SGI-110, decitabine and carboplatin in all patients during Cycle 1

Estimated Enrollment:	116
Study Start Date:	September 2012
Estimated Study Completion Date:	July 2014
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: SGI-110 and Carboplatin Part 1: Patients will be dosed with SGI-110 and carboplatin	Drug: SGI-110 and carboplatin
Experimental: SGI-110 and carboplatin or Treatment of Choice Part 2: Patients will be randomized to receive SGI-110 and carboplatin or Treatment of Choice. Treatment of choice 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 and carboplatin Drug: Treatment of Choice ( topotecan, pegylated liposomal doxorubicin, or paclitaxel) Investigator may choose to treat with either topotecan, pegylated liposomal doxorubicin, or paclitaxel

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who are women 18 years of age or older.
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.
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.
Patients must have had prior paclitaxel treatment.
Patients who have measurable disease according to RECIST v1.1 or detectable disease.
Patients with ECOG performance status of 0 or 1.
Patients with acceptable organ function.
Patients must be at least 3 weeks from last chemotherapy.

Exclusion Criteria:

Patients who have hypersensitivity to SGI-110 and/or carboplatin or other components of these drug products.
Patients who have received prior therapy with any hypomethylating agents.
Patients who are refractory to platinum treatment i.e., progressed while on platinum treatment.
Patients with abnormal left ventricular ejection fraction.
Patients with Grade 2 or greater neuropathy.
Patients with known brain metastases.
Patients with known history of HIV, HCV or HBV.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01696032

Contacts

Contact: Medpace Recruitment Center

1-866-872-2349

Show 24 Study Locations

Sponsors and Collaborators

Astex Pharmaceuticals

More Information

No publications provided

Responsible Party:	Astex Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01696032 History of Changes
Other Study ID Numbers:	SGI-110-02
Study First Received:	September 26, 2012
Last Updated:	April 12, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astex Pharmaceuticals:

Ovarian Cancer

Additional relevant MeSH terms:

Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Doxorubicin
Carboplatin
Paclitaxel

Topotecan
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013