Trial · NCT06789913
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Parts 1 and 2: Determination of a recommended phase 2 dose RP2D(s) for Groups 1, 2, and 3 | Cycle 1 of treatment and at the end of every cycle until study discontinuation | |
| Primary | Parts 1 and 2: Occurrence/frequency of Adverse Events (AEs), changes in vital signs, ECGs, and safety laboratory tests and their relationship to the study drugs (safety and tolerability). | Cycle 1 of treatment and at the end of every cycle until study discontinuation | |
| Primary | Part 3: Percentage of participants with volumetric Response. | Baseline, Week 24 | |
| Secondary | Part 1 and 2: Percent change from baseline in lesion volume | Baseline, Week 24 | |
| Secondary | Part 1 and 2: Duration of response, defined as the time of first documented response to the date of first documented disease progression or death due to any cause | Approximately every 3 months for approximately the first year, and then every 6 months during treatment | |
| Secondary | Part 1 and 2: Percentage of participants with volumetric response | Baseline, week 12, week 24 | |
| Secondary | Part 1 and 2: Plasma concentrations and PK parameters of RLY-2608 | Approximately every 2 weeks in Cycle 1, then again at Cycles 2, 4 and Cycle 7 depending on the participant's group | |
| Secondary | Part 1 and 2: PIK3CA mutational status in lesional fluid and/or tissue | Prior to enrollment | |
| Secondary | Part 3: Percentage of participants with improvement compared to baseline based on PGI-S, PGI-C and IGIC | Approximately once a month until end of treatment | |
| Secondary | Part 3: Change from baseline by age-appropriate PROMIS Profile | Approximately once a month until end of treatment | |
| Secondary | Part 3: Change from baseline in EQ-5D, EQ-5D-Y, or EQ-5D-Y Proxy | Approximately once a month until end of treatment | |
| Secondary | Part 3: Percent change from baseline in lesion volume | Approximately every 3 months for approximately the first year, and then every 6 months during treatment |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT06789913/registered