Effect of 2-h Infusion of ON 01910.Na in Ovarian Cancer Patients

NCT00856791 | Completed Phase 2 Results

• 1 other identifier: Onconova 04-12
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

ON 01910.Na has undergone preclinical and clinical phase I studies showing activity in patients with progressing ovarian cancer resistant to platinum-based chemotherapies. This study will look at a larger population of patients to determine whether treatment with ON 01910.Na has an effect on progression free survival rates in patients with platinum-resistant ovarian cancer. ON 01910.Na will be given as an intravenous infusion over 2 hours on days 1, 4, 8, 11, 15, and 18 of a 28-day cycle. Patients will be treated for 6 or more cycles.

Conditions

Ovarian Cancer

Keywords

Ovarian; Cancer; Cisplatin; Carboplatin

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Progression-free survival, defined as the number of days from the first day of study drug dosing to the day of documented disease progression or death, as assessed using RECIST (Response Evaluation Criteria in Solid Tumors) guidelines according to Therasse P, Arbuck SF, Eisenhauer EA, et al. (2000) J Natl Cancer Inst. 92:205-216. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter (LD)of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

  6 months

Secondary Outcomes (1)

• Number of Adverse Events

  6 months

Study Arms (1)

ON 01910.Na

EXPERIMENTAL

3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle

Drug: ON 01910.Na

Interventions

ON 01910.Na DRUG

Also known as: rigosertib, rigosertib sodium

ON 01910.Na

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with ovarian cancer at least 18 years old with measurable disease who have shown recurrent disease within 6 months of the last dose of cisplatin- or carboplatin-based chemotherapy. Measurable disease will be defined as lesions that can be accurately measured in at least one dimension with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2.
• No more than 3 prior chemotherapy regimens.
• Disease-free period of more than 5 years from prior malignancies other than ovarian (except curatively treated basal cell carcinoma, squamous cell carcinoma of the skin,or carcinoma in situ of the cervix).
• All female patients of childbearing potential must use at least one form of contraception as approved by the Investigator prior to study entry and for up to 30 days beyond the last administration of study drug.
• Women of childbearing potential must have a negative serum βHCG pregnancy test at screening.
• Willing to adhere to the prohibitions and restrictions specified in this protocol.
• Patient (or her legally authorized representative) must have signed an informed consent document.

You may not qualify if:

• Evidence of complete or partial bowel obstruction.
• Need for IV hydration or Total Parenteral Nutrition.
• Inability to comply with study and/or follow-up procedures.
• Life expectancy of less than 12 weeks.
• Prior radiotherapy to greater than one third of hematopoietic sites.
• Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
• Active infection not adequately responding to appropriate therapy.
• Hyponatremia (defined as serum sodium value of \<134 mEq/L).
• Total bilirubin ≥ 1.5 mg/dL not related to hemolysis or Gilbert's disease, AST/ALT or alkaline phosphatase ≥ 2 X ULN.
• Serum creatinine ≥ 2.0 mg/dL.
• ANC \< 1500/mm3, platelets \< 100,000/mm3; hemoglobin less than 9 g/dL.
• Ascites requiring active medical management including paracentesis for more than twice a month.
• Women patients who are pregnant or lactating or have a positive serum βHCG pregnancy test at screening.
• Major surgery without full recovery or major surgery within 3 weeks of ON 01910.Na treatment start.
• Uncontrolled hypertension (defined as a systolic pressure ≥ 160 and/or a diastolic pressure ≥ 110).

Sponsors & Collaborators

• Traws Pharma, Inc.: lead

Study Sites (1)

St. Vincent Gynecologic Oncology

Indianapolis, Indiana, 46260, United States

Location

Related Publications (5)

• Jimeno A, Li J, Messersmith WA, Laheru D, Rudek MA, Maniar M, Hidalgo M, Baker SD, Donehower RC. Phase I study of ON 01910.Na, a novel modulator of the Polo-like kinase 1 pathway, in adult patients with solid tumors. J Clin Oncol. 2008 Dec 1;26(34):5504-10. doi: 10.1200/JCO.2008.17.9788. Epub 2008 Oct 27.

  PMID: 18955447 BACKGROUND

• Jimeno A, Chan A, Cusatis G, Zhang X, Wheelhouse J, Solomon A, Chan F, Zhao M, Cosenza SC, Ramana Reddy MV, Rudek MA, Kulesza P, Donehower RC, Reddy EP, Hidalgo M. Evaluation of the novel mitotic modulator ON 01910.Na in pancreatic cancer and preclinical development of an ex vivo predictive assay. Oncogene. 2009 Jan 29;28(4):610-8. doi: 10.1038/onc.2008.424. Epub 2008 Nov 24.

  PMID: 19029951 BACKGROUND

• Reddy MV, Mallireddigari MR, Cosenza SC, Pallela VR, Iqbal NM, Robell KA, Kang AD, Reddy EP. Design, synthesis, and biological evaluation of (E)-styrylbenzylsulfones as novel anticancer agents. J Med Chem. 2008 Jan 10;51(1):86-100. doi: 10.1021/jm701077b. Epub 2007 Dec 19.

  PMID: 18088089 BACKGROUND

• Gumireddy K, Reddy MV, Cosenza SC, Boominathan R, Baker SJ, Papathi N, Jiang J, Holland J, Reddy EP. ON01910, a non-ATP-competitive small molecule inhibitor of Plk1, is a potent anticancer agent. Cancer Cell. 2005 Mar;7(3):275-86. doi: 10.1016/j.ccr.2005.02.009.

  PMID: 15766665 BACKGROUND

• Garcia-Manero G, Fenaux P. Comprehensive Analysis of Safety: Rigosertib in 557 Patients with Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML). Blood Dec 2016, 128 (22) 2011; ASH 2016.

  RESULT

Related Links

• Website of St. Vincent Health, one of the clinical sites conducting the study. Information about St. Vincent Health, links to other related sites.

MeSH Terms

Conditions

Ovarian Neoplasms; Neoplasms

Interventions

ON 01910

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Francois E. Wilhelm, MD, PhD
• Organization: Onconova Therapeutics, Inc.

fwilhelm@onconova.us

609 281-7086

Study Officials

• Gregory P. Sutton, MD

  St. Vincent Gynecologic Oncology, Indianapolis, IN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2009
• First Posted: March 6, 2009
• Study Start: March 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 21, 2017
• Results First Posted: January 8, 2013

Record last verified: 2017-06

Locations

US (1)