TriangleNCT01532687 · OUTCOME
Percentage of Participants Achieving Best Overall Objective Response (CR+PR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Best overall objective response recorded from the start of treatment until disease progression/recurrence assessed up to 3 years
What was measured
Response is evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, where RECIST combines assessments for target, non-target and presence of new lesions. Best Overall Objective Response is the sum of all CR+PR divided by all randomized participants, where the strongest recorded response is used for the evaluation (CR\>PR\>SD\>PD). Objective response (CR+PR) requires at least a 30% decrease in the sum of the largest diameter target lesions (with respective to the baseline sum); disappearance of all or persistence of one or more non-target lesions, maintenance of tumor marker levels above normal limits, and no new lesions. Estimated odds ratio of best overall objective response are reported with 95% confidence interval for the two histologic sarcoma subgroups (liposarcoma vs all other eligible soft tissue sarcoma subtypes). One-sided proportions test is used to determine whether best overall objective response is greater for the gemcitabine plus pazopanib group.
Analysis population: All randomized participants.
Groups in this outcome
Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and pazopanib hydrochloride PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib: Given PO Pazopanib Hydrochloride: Given PO
Gemcitabine Hydrochloride Plus Placebo
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and placebo PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may receive single-agent pazopanib hydrochloride PO daily. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib: Given PO Pazopanib Hydrochloride: Given PO Placebo Administration: Given PO
| Group | Source count |
|---|---|
| Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride | 29 |
| Gemcitabine Hydrochloride Plus Placebo | 25 |
Reported measurements
All randomized participants
| Group | Source count |
|---|---|
| Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride | 29 |
| Gemcitabine Hydrochloride Plus Placebo | 25 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride | 6.9 | Not reported | 0.9 | 22.8 | Not reported |
| Gemcitabine Hydrochloride Plus Placebo | 8.0 | Not reported | 1.0 | 26.0 | Not reported |
Liposarcoma participants
| Group | Source count |
|---|---|
| Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride | 9 |
| Gemcitabine Hydrochloride Plus Placebo | 7 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride | 22.2 | Not reported | 2.8 | 60 | Not reported |
| Gemcitabine Hydrochloride Plus Placebo | 0 | Not reported | NA | NA | No participants achieved overall objective response, making the confidence interval not estimable |
Other sarcoma participants
| Group | Source count |
|---|---|
| Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride | 20 |
| Gemcitabine Hydrochloride Plus Placebo | 18 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride | 0 | Not reported | NA | NA | No participants achieved overall objective response, making the confidence interval not estimable |
| Gemcitabine Hydrochloride Plus Placebo | 11.1 | Not reported | 1.4 | 34.7 | Not reported |
Source statistical analyses
- group Description
- Statistical results are for the full randomized population (n = 54). The study tests whether gemcitabine plus pazopanib is superior to gemcitabine plus placebo (one-sided proportion test with Yate's continuity correction)
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Analysis was not powered for secondary endpoints. Given the study closed early due to slow enrollment, we do not anticipate detecting a statistical difference between the two groups
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.5
- p Value Comment
- Yate's continuity correction was applied because of the number of subjects and successes (n = 4)
- statistical Method
- One-sided Proportions Test
- group Description
- Statistical results are for the Liposarcoma group (n = 16). The study tests whether gemcitabine plus pazopanib is superior to gemcitabine plus placebo (one-sided proportion test with Yate's continuity correction). Analysis was not powered for the secondary endpoints. Given the study closed early due to slow enrollment we do not anticipate detecting a statistical difference between the groups.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.3
- p Value Comment
- Yate's continuity correction was applied because of small number of participants (n = 16) and successes (n = 2).
- statistical Method
- One-sided Proportion Test
- group Description
- Statistical results are for the Other Sarcoma group (n = 38). The study tests whether gemcitabine plus pazopanib is superior to gemcitabine plus placebo (one-sided proportion test with Yate's continuity correction). Analysis was not powered for secondary endpoints. Given the study closed early due to slow enrollment, we do not anticipate detecting a statistical difference between the two groups.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.8
- p Value Comment
- Yate's continuity correction was applied because of the small number of participants and successes (n = 2).
- statistical Method
- One-sided Proportion Test
Complete source fields
- analyses
- group Description
- Statistical results are for the full randomized population (n = 54). The study tests whether gemcitabine plus pazopanib is superior to gemcitabine plus placebo (one-sided proportion test with Yate's continuity correction)
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Analysis was not powered for secondary endpoints. Given the study closed early due to slow enrollment, we do not anticipate detecting a statistical difference between the two groups
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.5
- p Value Comment
- Yate's continuity correction was applied because of the number of subjects and successes (n = 4)
- statistical Method
- One-sided Proportions Test
- group Description
- Statistical results are for the Liposarcoma group (n = 16). The study tests whether gemcitabine plus pazopanib is superior to gemcitabine plus placebo (one-sided proportion test with Yate's continuity correction). Analysis was not powered for the secondary endpoints. Given the study closed early due to slow enrollment we do not anticipate detecting a statistical difference between the groups.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.3
- p Value Comment
- Yate's continuity correction was applied because of small number of participants (n = 16) and successes (n = 2).
- statistical Method
- One-sided Proportion Test
- group Description
- Statistical results are for the Other Sarcoma group (n = 38). The study tests whether gemcitabine plus pazopanib is superior to gemcitabine plus placebo (one-sided proportion test with Yate's continuity correction). Analysis was not powered for secondary endpoints. Given the study closed early due to slow enrollment, we do not anticipate detecting a statistical difference between the two groups.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.8
- p Value Comment
- Yate's continuity correction was applied because of the small number of participants and successes (n = 2).
- statistical Method
- One-sided Proportion Test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.9
- upper Limit
- 22.8
- value
- 6.9
- group Id
- OG001
- lower Limit
- 1.0
- upper Limit
- 26.0
- value
- 8.0
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 25
- units
- Participants
- title
- All randomized participants
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.8
- upper Limit
- 60
- value
- 22.2
- comment
- No participants achieved overall objective response, making the confidence interval not estimable
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 7
- units
- Participants
- title
- Liposarcoma participants
- categories
- measurements
- comment
- No participants achieved overall objective response, making the confidence interval not estimable
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- group Id
- OG001
- lower Limit
- 1.4
- upper Limit
- 34.7
- value
- 11.1
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 18
- units
- Participants
- title
- Other sarcoma participants
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 25
- units
- Participants
- description
- Response is evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, where RECIST combines assessments for target, non-target and presence of new lesions. Best Overall Objective Response is the sum of all CR+PR divided by all randomized participants, where the strongest recorded response is used for the evaluation (CR\>PR\>SD\>PD). Objective response (CR+PR) requires at least a 30% decrease in the sum of the largest diameter target lesions (with respective to the baseline sum); disappearance of all or persistence of one or more non-target lesions, maintenance of tumor marker levels above normal limits, and no new lesions. Estimated odds ratio of best overall objective response are reported with 95% confidence interval for the two histologic sarcoma subgroups (liposarcoma vs all other eligible soft tissue sarcoma subtypes). One-sided proportions test is used to determine whether best overall objective response is greater for the gemcitabine plus pazopanib group.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and pazopanib hydrochloride PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib: Given PO Pazopanib Hydrochloride: Given PO
- id
- OG000
- title
- Gemcitabine Hydrochloride Plus Pazopanib Hydrochloride
- description
- Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and placebo PO on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may receive single-agent pazopanib hydrochloride PO daily. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Gemcitabine: Given IV Gemcitabine Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Pazopanib: Given PO Pazopanib Hydrochloride: Given PO Placebo Administration: Given PO
- id
- OG001
- title
- Gemcitabine Hydrochloride Plus Placebo
- param Type
- NUMBER
- population Description
- All randomized participants.
- reporting Status
- POSTED
- time Frame
- Best overall objective response recorded from the start of treatment until disease progression/recurrence assessed up to 3 years
- title
- Percentage of Participants Achieving Best Overall Objective Response (CR+PR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice