Trial · NCT03706365
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 | Radiographic Progression Free Survival (rPFS) | From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (Up to 60 Months) | The rPFS time is measured from the date of randomization to the earliest date of investigator determined radiographic disease progression (by objective radiographic disease assessment per response evaluation criteria in solid tumors (RECIST) version 1.1 for soft tissue AND/OR radionuclide bone scan using prostate cancer working group 3 -PCWG3 criteria for bone) or death from any cause, whichever occurs first. |
| Secondary | Time to Prostate-Specific Antigen (PSA) Progression | From Date of Randomization to the Date of the First Observation of PSA Progression (Up to 60 Months) | The PSA progression is defined as a greater than or equal to (\>=) 25 percentage (%) increase and an absolute increase of \>=2 nanogram/milliliter (ng/mL) above the nadir (or baseline value if baseline is the smallest on study), which is confirmed by a second value obtained 3 or more weeks later. |
| Secondary | Radiographic Progression Free Survival (rPFS) Determined by Blinded Independent Central Review | From Date of Randomization Until Radiographic Disease Progression or Death from Any Cause (Up to 60 Months) | rPFS is defined as the time from the date of randomization to the earliest date of radiographic disease progression determined by blinded independent central review (BICR) or death from any cause, whichever occurs first. |
| Secondary | Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR) | Baseline to Radiographic Disease Progression (Up to 60 Months) | ORR is a summary measure of best overall response (BOR) as defined by RECIST 1.1 for soft tissue per investigator assessment. BOR is derived from time point responses. All time point responses observed while on study treatment and during the short-term follow-up period (but before the initiation of post-discontinuation systemic anticancer therapy) will be included in the derivation. Each patient's BOR will be categorized as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE). A BOR of CR or PR will require confirmation, but sensitivity analyses of response-based endpoints may be performed where confirmation of a BOR of CR or PR is not required. |
| Secondary | Duration of Response (DOR) | Date of First Documented CR or PR to Date of Radiographic Disease Progression or Death from Any Cause (Up to 60 Months) | The DoR time is defined only for responders (participants with a soft tissue BOR of CR or PR) in the measurable disease population. It is measured from the date of first evidence of soft tissue CR or PR to the earliest date of investigator determined radiographic disease progression or death from any cause, whichever is earlier. |
| Secondary | Overall Survival (OS) | From Date of Randomization to Date of Death Due to Any Cause (Up to 60 Months) | The OS time is measured from the date of randomization to the date of death from any cause. If the participant was alive or lost to follow-up at the time of data analysis, OS data were censored on the last date the participant was known to be alive. |
| Secondary | Time to Symptomatic Progression | From Randomization to the Date of the First Documented Symptomatic Progression (Up to 60 Months) | Time to symptomatic progression is defined as the time from randomization to any of the following (whichever occurs earlier): 1. Symptomatic Skeletal Event (SSE), defined as symptomatic fracture, surgery or radiation to bone, or spinal cord compression. 2. Pain progression or worsening of disease-related symptoms requiring initiation of a new systemic anti-cancer therapy. 3. Development of clinically significant symptoms due to loco-regional tumor progression requiring surgical intervention or radiation therapy. |
| Secondary | Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib | Cycle (C) 1 Day (D) 1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle) | PK: Mean steady state exposure of abemaciclib. |
| Secondary | PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567 | C1 D1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle) | PK: Mean steady state exposure of abemaciclib metabolite LSN2839567. |
| Secondary | PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726 | C1 D1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle) | PK: Mean steady state exposure of abemaciclib metabolite LSN3106726. |
| Secondary | PK: Mean Steady State Exposure of Abiraterone Acetate | C1 D15, Post dose | PK: Mean Steady State Exposure of Abiraterone Acetate. |
| Secondary | Time to Worst Pain Progression | From Randomization Through Follow-up (Up to 60 months) | Time to Worst Pain Progression defined as the time from randomization to any of the following (whichever occurs earlier): For participants without opioid use at baseline (World Health Organization-Analgesic Ladder-WHO-AL ≤ 2):- Worst pain progression (an increase of 2 points from baseline on the Worst Pain Numeric Rating Scale (NRS) item on 2 consecutive evaluations), Initiation of weak or strong opioids (WHO-AL ≥ 3); For participants with weak or strong opioid use at baseline (WHO-AL ≥ 3): Worst pain progression (an increase of 2 points from baseline on the Worst Pain NRS item on 2 consecutive evaluations) without concurrent decreased opioid use (a decrease in WHO-AL of 1 or more) -Increased opioid use (an increase in WHO-AL of 1 or more). |
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
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GET https://conductscience.org/api/trials/v1/NCT03706365/registered