Trial · NCT03658772
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and tolerability of grapiprant alone and in combination with pembrolizumab | Up to 90 days after the end of treatment (average of 7 months) | Number of incidence, severity, and duration of treatment emergent adverse events using CTCAE v5.0 |
| Primary | Define the recommended phase 2 dose (RP2D) of grapiprant combined with pembrolizumab | Through Cycle 1 (21 days) | Number, incidence and severity of treatment related adverse events as assessed by CTCAE 5.0 |
| Secondary | Overall Response Rate (ORR) | 7 months | Proportion of participants who achieved PR or better during the study per RECIST 1.1 |
| Secondary | Duration of Response (DOR) | 7 months | Time when criteria for response are met, to the first documentation of relapse or progression |
| Secondary | Progression -free survival (PFS) | Up to 12 months | Participants who discontinue treatment without disease progression |
| Secondary | Disease control rate (DCR) | 7 months | Percentage of participants who achieved a CR, PR and stable disease |
| Secondary | Overall survival (OS) | Up to 2 years from start of study drug. | Date of study drug to date of death due to any cause. If no documentation of death at time of the analysis will be censored as of the date last known to be alive, or the data cutoff date, whichever is earlier. |
| Secondary | Duration of treatment (DOT) | 7 months | Time of duration on treatment |
| Secondary | Serum tumor marker changes | 7 months | Assess changes in serum tumor markers including but not limited to carcinoembryonic antigen (CEA), when appropriate (eg. CA-19.9, CA125, and lactate dehyrogenase (LDH)) with disease response. |
| Secondary | Pharmacodynamic immune effects in paired tumor biopsies | predose through cycle 3 (each cycle is 21 days) | Assess changes in tumor infiltrating helper T cells, cytotoxic T cells and regulatory monocyte/macrophages with study drug treatment |
| Secondary | PGEM as a pharmacodynamic and predictive biomarker | PreScreening through 7 months | Evaluate disease response in all evaluable participants and in those with a positive initial assessment of Urine prostaglandin E2 metabolite (PGEM) |
| Secondary | PK of grapiprant: Tmax | Safety Run-in (7 days); Days 1 and 2 of first 2 cycles (every 21 days), followed by Day 1 of every even cycle beginning with cycle 4 (every 42 days) through end of treatment (average of 4 months) | First time to reach maximum \[peak\] observed plasma concentration |
| Secondary | PK of grapiprant: AUC0 last | Safety Run-in (7 days); Days 1 and 2 of first 2 cycles (every 21 days), followed by Day 1 of every even cycle beginning with cycle 4 (every 42 days) through end of treatment (average of 4 months). | Area under the plasma concentration time curve from time 0 to the end of the dosing interval (AUC0 last) |
| Secondary | Plasma decay half-life (t1/2) | Safety Run-in (7 days); Days 1 and 2 of first 2 cycles (every 21 days), followed by Day 1 of every even cycle beginning with cycle 4 (every 42 days) through end of treatment (average of 4 months) | Measurement of half-life of grapiprant after dosing |
| Secondary | Apparent oral clearance (CL/F) | Safety Run-in (7 days); Days 1 and 2 of first 2 cycles (every 21 days), followed by Day 1 of every even cycle beginning with cycle 4 (every 42 days) through end of treatment (average of 4 months) | Rate of elimination of the drug from plasma after oral administration |
| Secondary | Peak to trough ratio | Safety Run-in (7 days); Days 1 and 2 of first 2 cycles (every 21 days), followed by Day 1 of every even cycle beginning with cycle 4 (every 42 days) through end of treatment (average of 4 months) | Measure how drug effect is sustained over dose interval |
| Secondary | Observed accumulation ratio | Safety Run-in (7 days); Days 1 and 2 of first 2 cycles (every 21 days), followed by Day 1 of every even cycle beginning with cycle 4 (every 42 days) through end of treatment (average of 4 months) | Relationship between the dosing interval and the rate of elimination for the drug. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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