Trial Outcomes & Findings for Ribavirin for Patients With Recurrent/Metastatic (R/M) Human Papillomavirus (HPV)-Related Malignancies (NCT NCT02308241)
NCT ID: NCT02308241
Last Updated: 2023-01-05
Results Overview
will be tabulated by adding partial responses and complete responses (CR + PR). The regimen would be considered worthy of further study if radiographic responses are observed in at least 2 of 12 subjects.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
1 year
Results posted on
2023-01-05
Participant Flow
Participant milestones
| Measure |
Ribavirin
Study subjects will self-administer ribavirin 1400 mg PO BID (total dose, 2800 mg/day). All patients will complete pill diaries to document administration of study drug. Cycle length is 28 days with continuous dosing. Clinic visits for safety assessments and routine laboratory studies will occur weekly in Cycle 1, in weeks 1 and 3 of Cycle 2, and on Week 1 of subsequent cycles. Cross sectional imaging (CT or MRI) is obtained at baseline and q2 cycles and at End-of Treatment (EOT). Response assessments will follow RECIST 1.1 criteria.
Ribavirin: self-administer ribavirin 1400 mg PO BID (total dose, 2800 mg/day)
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Ribavirin
Study subjects will self-administer ribavirin 1400 mg PO BID (total dose, 2800 mg/day). All patients will complete pill diaries to document administration of study drug. Cycle length is 28 days with continuous dosing. Clinic visits for safety assessments and routine laboratory studies will occur weekly in Cycle 1, in weeks 1 and 3 of Cycle 2, and on Week 1 of subsequent cycles. Cross sectional imaging (CT or MRI) is obtained at baseline and q2 cycles and at End-of Treatment (EOT). Response assessments will follow RECIST 1.1 criteria.
Ribavirin: self-administer ribavirin 1400 mg PO BID (total dose, 2800 mg/day)
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Ribavirin for Patients With Recurrent/Metastatic (R/M) Human Papillomavirus (HPV)-Related Malignancies
Baseline characteristics by cohort
| Measure |
Ribavirin
n=12 Participants
Study subjects will self-administer ribavirin 1400 mg PO BID (total dose, 2800 mg/day). All patients will complete pill diaries to document administration of study drug. Cycle length is 28 days with continuous dosing. Clinic visits for safety assessments and routine laboratory studies will occur weekly in Cycle 1, in weeks 1 and 3 of Cycle 2, and on Week 1 of subsequent cycles. Cross sectional imaging (CT or MRI) is obtained at baseline and q2 cycles and at End-of Treatment (EOT). Response assessments will follow RECIST 1.1 criteria.
Ribavirin: self-administer ribavirin 1400 mg PO BID (total dose, 2800 mg/day)
|
|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearwill be tabulated by adding partial responses and complete responses (CR + PR). The regimen would be considered worthy of further study if radiographic responses are observed in at least 2 of 12 subjects.
Outcome measures
| Measure |
Ribavirin
n=12 Participants
Study subjects will self-administer ribavirin 1400 mg PO BID (total dose, 2800 mg/day). All patients will complete pill diaries to document administration of study drug. Cycle length is 28 days with continuous dosing. Clinic visits for safety assessments and routine laboratory studies will occur weekly in Cycle 1, in weeks 1 and 3 of Cycle 2, and on Week 1 of subsequent cycles. Cross sectional imaging (CT or MRI) is obtained at baseline and q2 cycles and at End-of Treatment (EOT). Response assessments will follow RECIST 1.1 criteria.
Ribavirin: self-administer ribavirin 1400 mg PO BID (total dose, 2800 mg/day)
|
|---|---|
|
Radiographic Responses, Determined by RECIST 1.1 Criteria
Stable Disease
|
5 Participants
|
|
Radiographic Responses, Determined by RECIST 1.1 Criteria
Progression of Disease
|
4 Participants
|
|
Radiographic Responses, Determined by RECIST 1.1 Criteria
Unevaluable
|
3 Participants
|
SECONDARY outcome
Timeframe: 1 yearwill be tabulated using NCI CTCAE version 4,
Outcome measures
| Measure |
Ribavirin
n=12 Participants
Study subjects will self-administer ribavirin 1400 mg PO BID (total dose, 2800 mg/day). All patients will complete pill diaries to document administration of study drug. Cycle length is 28 days with continuous dosing. Clinic visits for safety assessments and routine laboratory studies will occur weekly in Cycle 1, in weeks 1 and 3 of Cycle 2, and on Week 1 of subsequent cycles. Cross sectional imaging (CT or MRI) is obtained at baseline and q2 cycles and at End-of Treatment (EOT). Response assessments will follow RECIST 1.1 criteria.
Ribavirin: self-administer ribavirin 1400 mg PO BID (total dose, 2800 mg/day)
|
|---|---|
|
Number of Participants Evaluated for Toxicity
|
12 Participants
|
Adverse Events
Ribavirin
Serious events: 3 serious events
Other events: 12 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Ribavirin
n=12 participants at risk
Study subjects will self-administer ribavirin 1400 mg PO BID (total dose, 2800 mg/day). All patients will complete pill diaries to document administration of study drug. Cycle length is 28 days with continuous dosing. Clinic visits for safety assessments and routine laboratory studies will occur weekly in Cycle 1, in weeks 1 and 3 of Cycle 2, and on Week 1 of subsequent cycles. Cross sectional imaging (CT or MRI) is obtained at baseline and q2 cycles and at End-of Treatment (EOT). Response assessments will follow RECIST 1.1 criteria.
Ribavirin: self-administer ribavirin 1400 mg PO BID (total dose, 2800 mg/day)
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • 1 year
|
|
Investigations
Blood bilirubin increased
|
8.3%
1/12 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
1/12 • 1 year
|
|
General disorders
Fever
|
8.3%
1/12 • 1 year
|
|
Nervous system disorders
Syncope
|
8.3%
1/12 • 1 year
|
Other adverse events
| Measure |
Ribavirin
n=12 participants at risk
Study subjects will self-administer ribavirin 1400 mg PO BID (total dose, 2800 mg/day). All patients will complete pill diaries to document administration of study drug. Cycle length is 28 days with continuous dosing. Clinic visits for safety assessments and routine laboratory studies will occur weekly in Cycle 1, in weeks 1 and 3 of Cycle 2, and on Week 1 of subsequent cycles. Cross sectional imaging (CT or MRI) is obtained at baseline and q2 cycles and at End-of Treatment (EOT). Response assessments will follow RECIST 1.1 criteria.
Ribavirin: self-administer ribavirin 1400 mg PO BID (total dose, 2800 mg/day)
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
12/12 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
6/12 • 1 year
|
|
Investigations
Blood bilirubin increased
|
41.7%
5/12 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
4/12 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
4/12 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
33.3%
4/12 • 1 year
|
|
General disorders
Fever
|
25.0%
3/12 • 1 year
|
|
Investigations
White blood cell decreased
|
25.0%
3/12 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
2/12 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
16.7%
2/12 • 1 year
|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • 1 year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
16.7%
2/12 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
2/12 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
2/12 • 1 year
|
|
Investigations
INR increased
|
16.7%
2/12 • 1 year
|
|
Investigations
Investigation - Other, specify
|
16.7%
2/12 • 1 year
|
|
Investigations
Platelet count decreased
|
16.7%
2/12 • 1 year
|
|
Investigations
Weight loss
|
16.7%
2/12 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
1/12 • 1 year
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
1/12 • 1 year
|
|
Nervous system disorders
Dysgeusia
|
8.3%
1/12 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.3%
1/12 • 1 year
|
|
Vascular disorders
Hypertension
|
8.3%
1/12 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.3%
1/12 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.3%
1/12 • 1 year
|
|
Psychiatric disorders
Insomnia
|
8.3%
1/12 • 1 year
|
|
Gastrointestinal disorders
Lip pain
|
8.3%
1/12 • 1 year
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
8.3%
1/12 • 1 year
|
|
Gastrointestinal disorders
Oral pain
|
8.3%
1/12 • 1 year
|
|
Cardiac disorders
Palpitations
|
8.3%
1/12 • 1 year
|
|
Infections and infestations
Paronychia
|
8.3%
1/12 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • 1 year
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
8.3%
1/12 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.3%
1/12 • 1 year
|
|
Nervous system disorders
Syncope
|
8.3%
1/12 • 1 year
|
|
Renal and urinary disorders
Urinary frequency
|
8.3%
1/12 • 1 year
|
|
Renal and urinary disorders
Urinary tract pain
|
8.3%
1/12 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
8.3%
1/12 • 1 year
|
Additional Information
Dr. David Pfister MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4237
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place