TriangleNCT03345784 · OUTCOME
Pharmacodynamic Effects of AZD1775 in Combination With RT and Concurrent Cisplatin
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- Up to 2 years
What was measured
To evaluate the pharmacodynamic effects of AZD1775 drugs when administered in combination with radiotherapy and concurrent cisplatin. Pharmacodynamic biomarkers will include: pCDC2, Ki67, γH2AX, pH3, and CC3. Associations between pharmacokinetic data with toxicity profiles will be performed primarily using descriptive statistics; however, logistic regression may be used if warranted.
Analysis population: Not analyzed as samples were not collected, therefore no data are available.
Groups in this outcome
Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1
Patients undergo external beam radiation therapy on days 1-5, receive AZD1775 PO on days 1, 3, and 5, and receive cisplatin IV over 1 hour on day 1 or 3. Cycles repeat each week for up to 5 weeks in the absence of disease progression of unacceptable toxicity.
Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1
Patients undergo external beam radiation therapy on days 1-5, receive AZD1775 PO on days 3 and 5, and receive cisplatin IV over 1 hour on day 1 or 3. Cycles repeat each week for up to 5 weeks in the absence of disease progression of unacceptable toxicity.
| Group | Source count |
|---|---|
| Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1 | 0 |
| Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1 | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- units
- Participants
- description
- To evaluate the pharmacodynamic effects of AZD1775 drugs when administered in combination with radiotherapy and concurrent cisplatin. Pharmacodynamic biomarkers will include: pCDC2, Ki67, γH2AX, pH3, and CC3. Associations between pharmacokinetic data with toxicity profiles will be performed primarily using descriptive statistics; however, logistic regression may be used if warranted.
- groups
- description
- Patients undergo external beam radiation therapy on days 1-5, receive AZD1775 PO on days 1, 3, and 5, and receive cisplatin IV over 1 hour on day 1 or 3. Cycles repeat each week for up to 5 weeks in the absence of disease progression of unacceptable toxicity.
- id
- OG000
- title
- Treatment (Radiation Therapy, AZD1775 3 Days/Week, Cisplatin) Dose Level 1
- description
- Patients undergo external beam radiation therapy on days 1-5, receive AZD1775 PO on days 3 and 5, and receive cisplatin IV over 1 hour on day 1 or 3. Cycles repeat each week for up to 5 weeks in the absence of disease progression of unacceptable toxicity.
- id
- OG001
- title
- Treatment (Radiation Therapy, AZD1775 2 Days/Week, Cisplatin) Dose Level -1
- population Description
- Not analyzed as samples were not collected, therefore no data are available.
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- Pharmacodynamic Effects of AZD1775 in Combination With RT and Concurrent Cisplatin
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice