Trial Outcomes & Findings for Belinostat in Treating Patients With Advanced Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer or Ovarian Low Malignant Potential Tumors (NCT NCT00301756)

Results Overview

Efficacy of belinostat in terms of complete or partial response; disappearance of all target lesions or at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) or Rustin criteria.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

32 participants

Primary outcome timeframe

Up to 5 years

Results posted on

2018-08-20

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Belinostat / Enzyme Inhibitor Therapy) Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	32
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Belinostat in Treating Patients With Advanced Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer or Ovarian Low Malignant Potential Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Enzyme Inhibitor Therapy) n=32 Participants Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	54 years n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Canada	32 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Efficacy of belinostat in terms of complete or partial response; disappearance of all target lesions or at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) or Rustin criteria.

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor Therapy) n=32 Participants Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Efficacy of Belinostat in Terms of Complete or Partial Response; Disappearance of All Target Lesions or at Least a 30% Decrease in the Sum of the Longest Diameter of Target Lesions, Taking as Reference the Baseline Sum LD	0 participants

SECONDARY outcome

Timeframe: Up to 5 years

Population: Eighteen patients with Epethelial Ovarian Cancer were analyzed

Assessed by RECIST criteria. Summarized using summary statistics, such as the mean, median, counts and proportion.

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor Therapy) n=18 Participants Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Time to Disease Progression (Epithelial Ovarian Cancer Group)	2.3 months Interval 1.2 to 5.7

SECONDARY outcome

Timeframe: Up to 5 years

Population: 14 patients with Low Malignant Potential tumours or Micropapillary / borderline were analyzed

Stable disease rate, defined as neither sufficient shrinkage to qualify for Partial Response nor sufficient increase to qualify for Progressive disease, taking as reference the smallest sum LD since the treatment started. Summarized using summary statistics, such as the mean, median, counts and proportion. Assessed by RECIST criteria.

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor Therapy) n=14 Participants Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Stable Disease Rate, Defined as Neither Sufficient Shrinkage to Qualify for PR Nor Sufficient Increase to Qualify for PD, Taking as Reference the Smallest Sum LD Since the Treatment Started (Low Malignant Potential Group)	10 participants

SECONDARY outcome

Timeframe: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years

Population: No participants had an objective response out of the 32 patients analyzed.

Summarized using summary statistics, such as the mean, median, counts and proportion. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Duration of time from start of treatment to time of progression, assessed up to 5 years

Computed using the Kaplan-Meier method. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor Therapy) n=12 Participants Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Progression-free Survival	13.4 months Interval 5.6 to 95% confidence interval, 5.6 to not reached

SECONDARY outcome

Timeframe: Up to 5 years

Population: Data were not collected

Computed using the Kaplan-Meier method. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Population: 18 patients with Epithelial ovarian cancer (EOC) and 14 patients with Micro-papillary ovarian tumor (LMP)

Events of Thrombosis, Hypersensitivity and ALP will be tabulated.

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor Therapy) n=32 Participants Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Number of Grade 3 Adverse Events Using the National Cancer Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0	5 events

SECONDARY outcome

Timeframe: Up to 5 years

Assessed by RECIST criteria. Summarized using summary statistics, such as the mean, median, counts and proportion.

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor Therapy) n=14 Participants Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Time to Disease Progression (Low Malignant Potential or Micropapillary / Borderline Ovarian Tumour Group)	13.4 months Interval 5.6 to A value is not available because the upper range was not reached

SECONDARY outcome

Timeframe: Up to 5 years

Population: 18 patients from Epithelian Ovarian Cancer patients were analyzed

Stable disease rate, defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Summarized using summary statistics, such as the mean, median, counts and proportion. Assessed by RECIST criteria.

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor Therapy) n=18 Participants Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Stable Disease Rate, Defined as Neither Sufficient Shrinkage to Qualify for PR Nor Sufficient Increase to Qualify for PD, Taking as Reference the Smallest Sum LD Since the Treatment Started (Epithelial Ovarian Cancer Group)	9 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 5 years

Summarized using summary statistics, such as the mean, median, and range. Tested using one-sample t-tests or Wilcoxon rank sum tests. Logistic regression analysis will be used to test significance.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Enzyme Inhibitor Therapy)

Serious events: 12 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Enzyme Inhibitor Therapy) n=32 participants at risk Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.1% 1/32
General disorders Fatigue	3.1% 1/32
Gastrointestinal disorders Small intestinal obstruction	3.1% 1/32
Gastrointestinal disorders Constipation	6.2% 2/32
Immune system disorders Cytokine release syndrome	3.1% 1/32
Musculoskeletal and connective tissue disorders Arthralgia	3.1% 1/32
General disorders Non-cardiac chest pain	3.1% 1/32
Vascular disorders Hypotension	3.1% 1/32
Infections and infestations Pleural infection	3.1% 1/32
Infections and infestations Urinary tract infection	3.1% 1/32
Gastrointestinal disorders Abdominal pain	3.1% 1/32
Respiratory, thoracic and mediastinal disorders Dyspnea	3.1% 1/32
Gastrointestinal disorders Upper gastrointestinal hemorrhage	3.1% 1/32
Investigations Activated partial thromboplastin time prolonged	3.1% 1/32
Metabolism and nutrition disorders Dehydration	3.1% 1/32
Gastrointestinal disorders Nausea	3.1% 1/32
Gastrointestinal disorders Lower gastrointestinal hemorrhage	3.1% 1/32

Other adverse events

Other adverse events
Measure	Treatment (Enzyme Inhibitor Therapy) n=32 participants at risk Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
General disorders Fatigue	87.5% 28/32
Gastrointestinal disorders Nausea	81.2% 26/32
Investigations Lymphocyte count decreased	75.0% 24/32
Gastrointestinal disorders Constipation	71.9% 23/32

Additional Information

Dr. Amit Oza

Princess Margaret Cancer Centre

Phone: 416-946-2818

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60