Trial · NCT03696212
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and tolerability of grapiprant in combination with pembrolizumab | Up to 90 days after the end of treatment (average of 7 months) | Number of incidence, severity, relationship, concomitant medications administered, 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 |
| Primary | Objective response rate (ORR) | 7 months | Proportion of participants who achieved PR or better during the study per RECIST 1.1 and iRECIST |
| Secondary | Progression-free survival (PFS) | Up to 12 months | Participants who discontinue treatment without disease progression |
| 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 |
| Secondary | Duration of treatment (DoT) | 7 months | Disease response for time of duration on treatment |
| Secondary | Disease control rate (DCR) | 7 months | Percentage of patients who have achieved CR, PR and stable disease |
| Secondary | Duration of response (DoR) | Up to 12 months | Time from documentation of tumor response to disease progression per RECIST and iRECIST 1.1 |
| Secondary | PK of grapiprant: AUC | 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 |
| Secondary | PK of grapiprant: Cmax | 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). | Peak serum concentration of grapiprant |
| Secondary | Plasma decay half-life (t1/2) | 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) | 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 | 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 | 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 |
| Secondary | Pharmacodynamic immune effects in paired tumor biopsies | Predose through cycle 3 (each cycle is 21 days) | Asses changes in tumor infiltrating helper T cells, cytoxic T cells and regulatory monocyte/macrophages with study treatment |
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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GET https://conductscience.org/api/trials/v1/NCT03696212/registered