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1. Part 1a - pharmacokinetics - Cmax (Time Frame - 16 days): Maximum plasma concentration (Cmax)
2. Part 1a - pharmacokinetics - AUC (Time Frame - 16 days): Area under the plasma concentration-time curve (AUC)
3. Part 1b - pharmacokinetics - Cmax (Time Frame - 14 days): Maximum plasma concentration (Cmax)
4. Part 1b - pharmacokinetics - AUC (Time Frame - 14 days): Area under the plasma concentration-time curve (AUC)
5. Part 1b - pharmacokinetics - Tmax (Time Frame - 14 days): Time to maximum observed plasma concentration (Tmax)
6. Part 2 - Progression Free Survival (PFS) (Time Frame - Approximately 48 months): Time from first dose to documented disease progression or death due to any cause, whichever occurs first
Secondary outcome:
1. All Study Parts - observing the safety of each treatment regimen. (Time Frame - Approximately 48 months): Incidence and severity of Adverse Events from first dose of study drug
2. All Study Parts - observing the safety of each treatment regimen. (Time Frame - Approximately 48 months): Incidence and severity of Serious Adverse Events from first dose of study drug
3. All Study Parts - observing the safety of each treatment regimen. (Time Frame - Approximately 48 months): Incidence of Adverse Events leading to dose modifications from first dose of study drug
4. All Study Parts - observing the safety of each treatment regimen. (Time Frame - Approximately 48 months): Change from baseline in laboratory results
5. All Study Parts - Overall Survival (OS) (Time Frame - Approximately 48 months): Time from first dose to death due to any cause
6. All Study Parts - Objective Response Rate (ORR) (Time Frame - Approximately 48 months): Percentage of subjects who achieved documented complete response (CR) + confirmed partial response (PR) based on modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
7. All Study Parts - Disease Control Rate (DCR) (Time Frame - Approximately 48 months): Percentage of subjects who achieved CR + PR + stable disease (SD) at 16 weeks
8. All Study Parts - Time to response (TTR) (Time Frame - Approximately 48 months): Time from first dose to first documented response based on modified Response Evaluation Criteria in Solid Tumors Version 1.1
9. All Study Parts - Duration of Response (DOR) (Time Frame - Approximately 48 months): Time from first response (CR or PR) to the date of progression or death from any cause, whichever occurs first
10. Part 2 Only - European Organisation for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-30) (Time Frame - Approximately 48 months): Change in individual scores in patients with locally advanced, unresectable, or metastatic GIST treated with CGT9486 in combination with sunitinib compared with patients treated with sunitinib monotherapy. The scale comprises 30 questions, 24 of which are aggregated into 9 multi-item scales, to include 5 functioning scales (physical, role, cognitive, emotional and social), 3 symptom scales (fatigue, pain and nausea/vomiting) and 1 global health status scale. The remaining 6 single-item scales assess symptoms (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea and the financial impact). All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning, while higher scores on the symptom and single-item scales indicate a higher level of symptoms.
CGT9486 plus sunitinib: Participants will receive both CGT9486 and sunitinib orally until study stopping rules are met.
CGT9486: Participants will receive CGT9486 until steady state then both CGT9486 and sunitinib orally until study stopping rules are met.
Sunitinib (sunitinib - Part 1b): Participants will receive sunitinib until steady state then both sunitinib and CGT9486 orally until study stopping rules are met.
Sunitinib (sunitinib - Part 2): Participants will receive sunitinib orally until study stopping rules are met.
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors"
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