TriangleNCT01624090 · OUTCOME
Number of Participants With an Objective Response (Complete Response + Partial Response)
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
- Every 8 weeks until disease progression or unacceptable toxicity, over an average of 4 months.
What was measured
Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10mm. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesion, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions). Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Analysis population: One participant in DL1 30 mcg thoracic died on study, one participant in DL1 30 mcg extra thoracic experienced a dose limiting toxicity and was taken off therapy, and 1 withdrew prior to trmt, two participants in DL1 25 mcg thoracic died on study, and two did not complete one course of therapy prior to treatment evaluation for this outcome measure.
Groups in this outcome
Dose Level 1 - 30 mcg/kg Thoracic Malignancy
Single agent intravenous (IV) mithramycin Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity.
Dose Level 1 - 30 mcg/kg Extra Thoracic Malignancy
Single agent intravenous (IV) mithramycin Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity.
Dose Level -1 - 25 mcg/kg Thoracic Malignancy
Single agent intravenous (IV) mithramycin Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle).
Dose Level -1 - 25 mcg/kg Extra Thoracic Malignancy
Single agent intravenous (IV) mithramycin Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle).
| Group | Source count |
|---|---|
| Dose Level 1 - 30 mcg/kg Thoracic Malignancy | 1 |
| Dose Level 1 - 30 mcg/kg Extra Thoracic Malignancy | 0 |
| Dose Level -1 - 25 mcg/kg Thoracic Malignancy | 6 |
| Dose Level -1 - 25 mcg/kg Extra Thoracic Malignancy | 2 |
Reported measurements
Source class 1
Complete Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 - 30 mcg/kg Thoracic Malignancy | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 1 - 30 mcg/kg Extra Thoracic Malignancy | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level -1 - 25 mcg/kg Thoracic Malignancy | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level -1 - 25 mcg/kg Extra Thoracic Malignancy | 0 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 - 30 mcg/kg Thoracic Malignancy | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 1 - 30 mcg/kg Extra Thoracic Malignancy | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level -1 - 25 mcg/kg Thoracic Malignancy | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level -1 - 25 mcg/kg Extra Thoracic Malignancy | 0 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 - 30 mcg/kg Thoracic Malignancy | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 1 - 30 mcg/kg Extra Thoracic Malignancy | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level -1 - 25 mcg/kg Thoracic Malignancy | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level -1 - 25 mcg/kg Extra Thoracic Malignancy | 0 | Not reported | Not reported | Not reported | Not reported |
Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 - 30 mcg/kg Thoracic Malignancy | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 1 - 30 mcg/kg Extra Thoracic Malignancy | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level -1 - 25 mcg/kg Thoracic Malignancy | 6 | Not reported | Not reported | Not reported | Not reported |
| Dose Level -1 - 25 mcg/kg Extra Thoracic Malignancy | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Complete Response
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Partial Response
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Stable Disease
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 2
- title
- Progressive Disease
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 2
- units
- Participants
- description
- Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10mm. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesion, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions). Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
- groups
- description
- Single agent intravenous (IV) mithramycin Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Dose Level 1 - 30 mcg/kg Thoracic Malignancy
- description
- Single agent intravenous (IV) mithramycin Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity.
- id
- OG001
- title
- Dose Level 1 - 30 mcg/kg Extra Thoracic Malignancy
- description
- Single agent intravenous (IV) mithramycin Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle).
- id
- OG002
- title
- Dose Level -1 - 25 mcg/kg Thoracic Malignancy
- description
- Single agent intravenous (IV) mithramycin Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle).
- id
- OG003
- title
- Dose Level -1 - 25 mcg/kg Extra Thoracic Malignancy
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- One participant in DL1 30 mcg thoracic died on study, one participant in DL1 30 mcg extra thoracic experienced a dose limiting toxicity and was taken off therapy, and 1 withdrew prior to trmt, two participants in DL1 25 mcg thoracic died on study, and two did not complete one course of therapy prior to treatment evaluation for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Every 8 weeks until disease progression or unacceptable toxicity, over an average of 4 months.
- title
- Number of Participants With an Objective Response (Complete Response + Partial Response)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice