NCT01771107 · OUTCOME
Maximal Tolerated Dose of Brentuximab Vedotin (Phase I)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- mg/kg
- Interval / dispersion
- Not reported
- Time frame
- 28 days
What was measured
Defined as the dose level at which =\< 1 of 6 subjects experience dose limiting toxicity.
Analysis population: Participants entered into the phase I portion of the study
Groups in this outcome
Treatment (Brentuximab and Combination Chemotherapy)
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
| Group | Source count |
|---|---|
| Treatment (Brentuximab and Combination Chemotherapy) | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Brentuximab and Combination Chemotherapy) | 1.2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1.2
- denoms
- counts
- group Id
- OG000
- value
- 6
- units
- Participants
- description
- Defined as the dose level at which =\< 1 of 6 subjects experience dose limiting toxicity.
- groups
- description
- Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
- id
- OG000
- title
- Treatment (Brentuximab and Combination Chemotherapy)
- param Type
- NUMBER
- population Description
- Participants entered into the phase I portion of the study
- reporting Status
- POSTED
- time Frame
- 28 days
- title
- Maximal Tolerated Dose of Brentuximab Vedotin (Phase I)
- type
- PRIMARY
- unit Of Measure
- mg/kg
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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