Trial Outcomes & Findings for Effect of 2-h Infusion of ON 01910.Na in Ovarian Cancer Patients (NCT NCT00856791)

Last Updated: 2017-07-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

6 months

Results posted on

2017-07-21

Participant Flow

The study was conducted at one site in the United States. One patient was enrolled and treated, after which, the study was closed due to slow enrollment.

Participant milestones

Participant milestones
Measure	ON 01910.Na 3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ON 01910.Na n=1 Participants 3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	ON 01910.Na n=1 Participants 3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
Progression Free Survival	54 day

SECONDARY outcome

Timeframe: 6 months

The number of adverse events and their severity rating will be classified according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, version 3.0.

Outcome measures

Outcome measures
Measure	ON 01910.Na n=1 Participants 3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
Number of Adverse Events	9 Adverse event

Adverse Events

ON 01910.Na

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ON 01910.Na n=1 participants at risk 3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
Metabolism and nutrition disorders Hypomagnesia	100.0% 1/1 • Number of events 1 • 6 months
Gastrointestinal disorders Constipation	100.0% 1/1 • Number of events 1 • 6 months
Respiratory, thoracic and mediastinal disorders Cough	100.0% 1/1 • Number of events 1 • 6 months
Respiratory, thoracic and mediastinal disorders Dyspnea	100.0% 1/1 • Number of events 1 • 6 months
Respiratory, thoracic and mediastinal disorders Pleural effusion	100.0% 1/1 • Number of events 2 • 6 months
Musculoskeletal and connective tissue disorders Pain-right flank	100.0% 1/1 • Number of events 1 • 6 months
General disorders Fatigue	100.0% 1/1 • Number of events 1 • 6 months
Gastrointestinal disorders Nausea	100.0% 1/1 • Number of events 1 • 6 months
Renal and urinary disorders Hematuria	100.0% 1/1 • Number of events 1 • 6 months

Additional Information

Francois E. Wilhelm, MD, PhD

Onconova Therapeutics, Inc.

Phone: 609 281-7086

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Investigators agree to inform the Sponsor of any publication or presentations on the study. All manuscripts, abstracts or presentations (in outline form with copies of slides if available) will be submitted to the Sponsor at least 30 days prior to the submission of the data for publication in order for the Sponsor to protect proprietary information. The Sponsor will review the submitted material within a reasonable period of time and will not unreasonably withhold publication permission.
Publication restrictions are in place

Restriction type: OTHER