TriangleNCT01248949 · OUTCOME
Maximum Tolerated Dose (MTD)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- milligram (mg)
- Interval / dispersion
- Not reported
- Time frame
- From the time of first administration of MEDI3617 single agent or MEDI3617 combination therapy through the first 21-day or 28-day cycle (Cycle 1)
What was measured
The dose-escalation phase used a 3 + 3 design. If greater than or equal to 2 (≥ 2) participants in a dose cohort experienced a DLT during the DLT period, the MTD was exceeded and no further participants were enrolled into that dose cohort. If this occurred, the preceding dose cohort was evaluated for the MTD and a total of 6 participants were treated at the preceding dose. If less than or equal to 1 (≤ 1) of 6 participants experienced a DLT at the preceding dose, then this dose level was the MTD. DLTs were defined as any treatment-related, grade 3 or higher toxicity (according to the National Cancer Institute's Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 4.0); occurring during the first 21 or 28 days after the initial administration of MEDI3617.
Analysis population: DLT Evaluable population included all participants enrolled in dose-escalation, who received at least 1 full assigned dose of single-agent MEDI3617 or full assigned doses of MEDI3617 and standard therapeutic agents on Cycle 1 and completed safety follow-up or experienced a DLT at any point during the 21-day or 28-day DLT evaluation period.
Groups in this outcome
MEDI3617 SINGLE AGENT TOTAL
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
MEDI3617 + BEVACIZUMAB Q2W TOTAL
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
MEDI3617 + PACLITAXEL TOTAL
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
| Group | Source count |
|---|---|
| MEDI3617 SINGLE AGENT TOTAL | 23 |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | 15 |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | 22 |
| MEDI3617 + PACLITAXEL TOTAL | 11 |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MEDI3617 SINGLE AGENT TOTAL | NA | Not reported | Not reported | Not reported | The highest dose level was cleared and the MTD was not reached. |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | NA | Not reported | Not reported | Not reported | A DLT was reported at the highest dose level, but only 5 out of the 6 participants enrolled were evaluable for DLT. Thus, it is unclear if the MTD was exceeded or reached at the highest dose level tested. |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | NA | Not reported | Not reported | Not reported | The highest dose level was cleared and the MTD was not reached. |
| MEDI3617 + PACLITAXEL TOTAL | NA | Not reported | Not reported | Not reported | The highest dose level was cleared and the MTD was not reached. |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | NA | Not reported | Not reported | Not reported | A DLT was reported at the highest dose level, but it is unclear if the MTD was exceeded or reached, as only 3 participants were enrolled (all participants were evaluable for DLT). |
Complete source fields
- classes
- categories
- measurements
- comment
- The highest dose level was cleared and the MTD was not reached.
- group Id
- OG000
- value
- NA
- comment
- A DLT was reported at the highest dose level, but only 5 out of the 6 participants enrolled were evaluable for DLT. Thus, it is unclear if the MTD was exceeded or reached at the highest dose level tested.
- group Id
- OG001
- value
- NA
- comment
- The highest dose level was cleared and the MTD was not reached.
- group Id
- OG002
- value
- NA
- comment
- The highest dose level was cleared and the MTD was not reached.
- group Id
- OG003
- value
- NA
- comment
- A DLT was reported at the highest dose level, but it is unclear if the MTD was exceeded or reached, as only 3 participants were enrolled (all participants were evaluable for DLT).
- group Id
- OG004
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 11
- group Id
- OG004
- value
- 6
- units
- Participants
- description
- The dose-escalation phase used a 3 + 3 design. If greater than or equal to 2 (≥ 2) participants in a dose cohort experienced a DLT during the DLT period, the MTD was exceeded and no further participants were enrolled into that dose cohort. If this occurred, the preceding dose cohort was evaluated for the MTD and a total of 6 participants were treated at the preceding dose. If less than or equal to 1 (≤ 1) of 6 participants experienced a DLT at the preceding dose, then this dose level was the MTD. DLTs were defined as any treatment-related, grade 3 or higher toxicity (according to the National Cancer Institute's Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 4.0); occurring during the first 21 or 28 days after the initial administration of MEDI3617.
- groups
- description
- Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
- id
- OG000
- title
- MEDI3617 SINGLE AGENT TOTAL
- description
- Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
- id
- OG001
- title
- MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
- description
- Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
- id
- OG002
- title
- MEDI3617 + BEVACIZUMAB Q2W TOTAL
- description
- Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
- id
- OG003
- title
- MEDI3617 + PACLITAXEL TOTAL
- description
- Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
- id
- OG004
- title
- MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
- param Type
- NUMBER
- population Description
- DLT Evaluable population included all participants enrolled in dose-escalation, who received at least 1 full assigned dose of single-agent MEDI3617 or full assigned doses of MEDI3617 and standard therapeutic agents on Cycle 1 and completed safety follow-up or experienced a DLT at any point during the 21-day or 28-day DLT evaluation period.
- reporting Status
- POSTED
- time Frame
- From the time of first administration of MEDI3617 single agent or MEDI3617 combination therapy through the first 21-day or 28-day cycle (Cycle 1)
- title
- Maximum Tolerated Dose (MTD)
- type
- PRIMARY
- unit Of Measure
- milligram (mg)
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Preserved source evidence · Not medical advice