TriangleNCT02797964 · OUTCOME
Time to Progression (TTP)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Radiographic tumor assessments were performed every 2 cycles of therapy. Follow-up assessments were made every 16 weeks for subjects who had not progressed and had not initiated new anticancer therapy.
What was measured
Time to progression (TTP) was defined as the time from Cycle 1 Day 1 to the earliest date of radiographic disease progression per RECIST 1.1, or if the subject did not experience disease progression, to the last imaging assessment. TTP was analyzed using the K-M method.
Analysis population: The Response Evaluable Population (REP) included all enrolled subjects who satisfy all of the following conditions: 1. Measurable disease and assessment at baseline 2. Received at least 75% of 1 cycle of study medication, based on dosing information 3. At least one post baseline disease assessment OR discontinued treatment due to AE or disease progression or death
Groups in this outcome
Colorectal Cancer
Metastatic colorectal cancer (CRC) defined as histologically and/or cytologically confirmed CRC, and must have received at least 1 prior regimen for advanced/metastatic disease.
High Grade Serous Ovarian Cancer
High grade serous ovarian cancer (HGSOC) defined as histologically confirmed high grade serous ovarian, fallopian tube or primary peritoneal cancer who were recurrent platinum intolerant, or with platinum resistant disease defined as radiological evidence of disease progression within 6 months of the last receipt of platinum based chemotherapy.
Non Small Cell Lung Cancer
Advanced non small cell lung cancer (NSCLC) defined as locally advanced and recurrent or metastatic, histologically confirmed NSCLC, and must have received at least 1 prior regimen for advanced/metastatic disease.
Metastatic Other Tumor Type Castration Resistant Prostate Cancer
Metastatic castration resistant prostate cancer (mCRPC) defined as histologically or cytologically confirmed adenocarcinoma of the prostate that has progressed after androgen deprivation therapy.
Head and Neck Squamous Cell Carcinoma
Histologically confirmed HNSCC from any primary site; locally advanced disease (ie, persistent or progressive disease following curative intent radiation, and not a candidate for surgical salvage due to incurability or morbidity), or metastatic disease.
| Group | Source count |
|---|---|
| Colorectal Cancer | 24 |
| High Grade Serous Ovarian Cancer | 26 |
| Non Small Cell Lung Cancer | 8 |
| Metastatic Other Tumor Type Castration Resistant Prostate Cancer | 13 |
| Head and Neck Squamous Cell Carcinoma | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Colorectal Cancer | 1.87 | Not reported | 1.68 | 3.06 | Not reported |
| High Grade Serous Ovarian Cancer | 1.94 | Not reported | 1.81 | 3.68 | Not reported |
| Non Small Cell Lung Cancer | 1.87 | Not reported | 1.41 | NA | The upper 95% CI was not estimated due to insufficient number of participants with events |
| Metastatic Other Tumor Type Castration Resistant Prostate Cancer | 3.02 | Not reported | 1.64 | NA | The upper 95% CI was not estimated due to insufficient number of participants with events |
| Head and Neck Squamous Cell Carcinoma | 3.87 | Not reported | 1.64 | NA | The upper 95% CI was not estimated due to insufficient number of participants with events |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.68
- upper Limit
- 3.06
- value
- 1.87
- group Id
- OG001
- lower Limit
- 1.81
- upper Limit
- 3.68
- value
- 1.94
- comment
- The upper 95% CI was not estimated due to insufficient number of participants with events
- group Id
- OG002
- lower Limit
- 1.41
- upper Limit
- NA
- value
- 1.87
- comment
- The upper 95% CI was not estimated due to insufficient number of participants with events
- group Id
- OG003
- lower Limit
- 1.64
- upper Limit
- NA
- value
- 3.02
- comment
- The upper 95% CI was not estimated due to insufficient number of participants with events
- group Id
- OG004
- lower Limit
- 1.64
- upper Limit
- NA
- value
- 3.87
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 26
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 4
- units
- Participants
- description
- Time to progression (TTP) was defined as the time from Cycle 1 Day 1 to the earliest date of radiographic disease progression per RECIST 1.1, or if the subject did not experience disease progression, to the last imaging assessment. TTP was analyzed using the K-M method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Metastatic colorectal cancer (CRC) defined as histologically and/or cytologically confirmed CRC, and must have received at least 1 prior regimen for advanced/metastatic disease.
- id
- OG000
- title
- Colorectal Cancer
- description
- High grade serous ovarian cancer (HGSOC) defined as histologically confirmed high grade serous ovarian, fallopian tube or primary peritoneal cancer who were recurrent platinum intolerant, or with platinum resistant disease defined as radiological evidence of disease progression within 6 months of the last receipt of platinum based chemotherapy.
- id
- OG001
- title
- High Grade Serous Ovarian Cancer
- description
- Advanced non small cell lung cancer (NSCLC) defined as locally advanced and recurrent or metastatic, histologically confirmed NSCLC, and must have received at least 1 prior regimen for advanced/metastatic disease.
- id
- OG002
- title
- Non Small Cell Lung Cancer
- description
- Metastatic castration resistant prostate cancer (mCRPC) defined as histologically or cytologically confirmed adenocarcinoma of the prostate that has progressed after androgen deprivation therapy.
- id
- OG003
- title
- Metastatic Other Tumor Type Castration Resistant Prostate Cancer
- description
- Histologically confirmed HNSCC from any primary site; locally advanced disease (ie, persistent or progressive disease following curative intent radiation, and not a candidate for surgical salvage due to incurability or morbidity), or metastatic disease.
- id
- OG004
- title
- Head and Neck Squamous Cell Carcinoma
- param Type
- MEDIAN
- population Description
- The Response Evaluable Population (REP) included all enrolled subjects who satisfy all of the following conditions: 1. Measurable disease and assessment at baseline 2. Received at least 75% of 1 cycle of study medication, based on dosing information 3. At least one post baseline disease assessment OR discontinued treatment due to AE or disease progression or death
- reporting Status
- POSTED
- time Frame
- Radiographic tumor assessments were performed every 2 cycles of therapy. Follow-up assessments were made every 16 weeks for subjects who had not progressed and had not initiated new anticancer therapy.
- title
- Time to Progression (TTP)
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice