TriangleNCT02142803 · OUTCOME
Objective Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 2 years
What was measured
Objective Response Rate (ORR), defined as a Complete Response (CR) or Partial Response (PR) utilizing: 1. RECIST criteria v.1.1 (Endometrial \& Ovarian Cancers): * CR: Disappearance of all target \& non-target lesions (+ normalization of tumor marker level) * PR: \>/= 30% decrease in sum of the longest diameters of target lesions (from baseline) \& no new lesions 2. RANO criteria (GBM patients): * CR: * Disappearance of all enhancing measurable \& non-measurable disease (sustained \>/= 4 wks) * No new lesions * No steroids (physiologic replacement doses only) * Stable or improved non-enhancing lesions * Clinically stable or improved * PR: * \>/= 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions (sustained \>/= 4 wks) * No progression of non-measurable disease * No new lesions * Steroid \</= dose at time of baseline scan * Stable or improved non-enhancing lesions * Clinically stable or improved
Groups in this outcome
Dose Level 1
3 mg MLN0128 Daily
Dose Level 2
4 mg MLN0128 Daily
Dose Level 3 (MTD)
5 mg MLN0128 Daily
| Group | Source count |
|---|---|
| Dose Level 1 | 3 |
| Dose Level 2 | 3 |
| Dose Level 3 (MTD) | 43 |
Reported measurements
Source class 1
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3 (MTD) | 0 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3 (MTD) | 8 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3 (MTD) | 20 | Not reported | Not reported | Not reported | Not reported |
Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3 (MTD) | 7 | Not reported | Not reported | Not reported | Not reported |
Unevaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3 (MTD) | 8 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Complete Response
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 8
- title
- Partial Response
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 20
- title
- Stable Disease
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 7
- title
- Progressive Disease
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 8
- title
- Unevaluable
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 43
- units
- Participants
- description
- Objective Response Rate (ORR), defined as a Complete Response (CR) or Partial Response (PR) utilizing: 1. RECIST criteria v.1.1 (Endometrial \& Ovarian Cancers): * CR: Disappearance of all target \& non-target lesions (+ normalization of tumor marker level) * PR: \>/= 30% decrease in sum of the longest diameters of target lesions (from baseline) \& no new lesions 2. RANO criteria (GBM patients): * CR: * Disappearance of all enhancing measurable \& non-measurable disease (sustained \>/= 4 wks) * No new lesions * No steroids (physiologic replacement doses only) * Stable or improved non-enhancing lesions * Clinically stable or improved * PR: * \>/= 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions (sustained \>/= 4 wks) * No progression of non-measurable disease * No new lesions * Steroid \</= dose at time of baseline scan * Stable or improved non-enhancing lesions * Clinically stable or improved
- groups
- description
- 3 mg MLN0128 Daily
- id
- OG000
- title
- Dose Level 1
- description
- 4 mg MLN0128 Daily
- id
- OG001
- title
- Dose Level 2
- description
- 5 mg MLN0128 Daily
- id
- OG002
- title
- Dose Level 3 (MTD)
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- Objective Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice