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Enzalutamide or Abiraterone or Apalutamid for Prostate Cancer
Phase 1
Waitlist Available
Research Sponsored by Kangpu Biopharmaceuticals, Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to cycle-6 (28-day per cycle)
Awards & highlights
Study Summary
This trial is testing a new drug, KPG-121, to see if it is safe and effective in treating prostate cancer. The drug will be given orally once daily for 28 days, then the patient will have 7 days off. The study will enroll adult subjects who have either non-metastatic or metastatic castration-resistant prostate cancer.
Eligible Conditions
- Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to cycle-6 (28-day per cycle)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to cycle-6 (28-day per cycle)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of KPG-121
Secondary outcome measures
Incidence of Adverse Events [Safety and Tolerability]
Pharmacokinetic (PK) profile of KPG-121
Trial Design
1Treatment groups
Experimental Treatment
Group I: KPG-121Experimental Treatment1 Intervention
Safety and Antitumor Activity of KPG-121 capsules at different dose level for 21 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide or Abiraterone or Apalutamid
2019
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Kangpu Biopharmaceuticals, Ltd.Lead Sponsor
3 Previous Clinical Trials
134 Total Patients Enrolled
Yao Wang, MDStudy DirectorKangpu Biopharmacuticals
YONG GUO, MDStudy DirectorKangpu Biopharmacuticals
Frequently Asked Questions
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