TriangleNCT02595879 · OUTCOME
Bioavailability of Triapine
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- percentage
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 2 weeks
What was measured
The oral bioavailability of the oral form of the triapine will be measured as a numeric value using mass spectrophotometry.
Analysis population: Patients that had both PO and IV triapine PK samples
Groups in this outcome
Triapine (100mg) + Chemoradiation)
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up. Biospecimen Collection: Undergo collection of blood samples Brachytherapy: Undergo LDR brachytherapy Cisplatin: Given IV Computed Tomography: Undergo FDG-PET/CT External Beam Radiation Therapy: Undergo pelvic EBRT Fludeoxyglucose F-18: Undergo FDG-PET/CT High-Dose Rate Brachytherapy: Undergo HDR brachytherapy Intensity-Modulated Radiation Therapy: Undergo IMRT Magnetic Resonance Imaging: Undergo MRI Pharmacological Study: Correlative studies Positron Emission Tomography: Undergo FDG-PET/CT Triapine: Given IV and PO
Triapine (150mg) + Chemoradiation)
Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up.
| Group | Source count |
|---|---|
| Triapine (100mg) + Chemoradiation) | 16 |
| Triapine (150mg) + Chemoradiation) | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Triapine (100mg) + Chemoradiation) | 60 | Not reported | 16 | 229 | Not reported |
| Triapine (150mg) + Chemoradiation) | 54 | Not reported | 15 | 200 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 16
- upper Limit
- 229
- value
- 60
- group Id
- OG001
- lower Limit
- 15
- upper Limit
- 200
- value
- 54
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 4
- units
- Participants
- description
- The oral bioavailability of the oral form of the triapine will be measured as a numeric value using mass spectrophotometry.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up. Biospecimen Collection: Undergo collection of blood samples Brachytherapy: Undergo LDR brachytherapy Cisplatin: Given IV Computed Tomography: Undergo FDG-PET/CT External Beam Radiation Therapy: Undergo pelvic EBRT Fludeoxyglucose F-18: Undergo FDG-PET/CT High-Dose Rate Brachytherapy: Undergo HDR brachytherapy Intensity-Modulated Radiation Therapy: Undergo IMRT Magnetic Resonance Imaging: Undergo MRI Pharmacological Study: Correlative studies Positron Emission Tomography: Undergo FDG-PET/CT Triapine: Given IV and PO
- id
- OG000
- title
- Triapine (100mg) + Chemoradiation)
- description
- Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up.
- id
- OG001
- title
- Triapine (150mg) + Chemoradiation)
- param Type
- GEOMETRIC_MEAN
- population Description
- Patients that had both PO and IV triapine PK samples
- reporting Status
- POSTED
- time Frame
- Up to 2 weeks
- title
- Bioavailability of Triapine
- type
- PRIMARY
- unit Of Measure
- percentage
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice