Actively Recruiting
Study of Pazopanib Combined With Palbociclib for Refractory Solid Tumors With Co-amplified in the 11q13(FGF3/4/19/CCND1)
Led by Tianjin Medical University Second Hospital · Updated on 2025-03-26
65
Participants Needed
1
Research Sites
57 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The efficacy and safety of Pazopanib combined with Palbociclib in the third line and above treatment of refractory solid tumors co amplified in the 11q13 region (FGF3/4/19/CCND1).
CONDITIONS
Official Title
Study of Pazopanib Combined With Palbociclib for Refractory Solid Tumors With Co-amplified in the 11q13(FGF3/4/19/CCND1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Age 18 years or older
- Diagnosed with metastatic solid tumors by histology or cytology, including urothelial carcinoma with 11q13 or FGFR1/2 amplification, head and neck squamous cell carcinoma with 11q13 co-amplification, or other solid tumors with 11q13 co-amplification
- Disease progression or intolerable toxicity after at least two prior standard treatments
- At least one measurable lesion according to RECIST 1.1 criteria
- Ability to swallow pills normally
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Expected survival time of at least 12 weeks
- Adequate organ function with specified blood counts and liver, kidney function within defined limits
- Use of medically approved contraceptive methods during treatment and for 3 months after, if applicable
- Negative pregnancy test within 7 days before starting treatment for women of childbearing age
- Non-lactating status for female participants of childbearing potential
- Male participants with partners of childbearing potential must use effective contraception during and for 3 months after treatment
You will not qualify if you...
- History or evidence of interstitial lung disease or active non-infectious pneumonia
- Known central nervous system metastases
- Other malignant tumors within past 5 years (except cured basal cell carcinoma or cervical carcinoma in situ)
- Uncontrolled hypertension or history of hypertensive crisis
- Significant heart conditions including heart failure, unstable angina, recent myocardial infarction, serious arrhythmias, or prolonged QTc interval
- Recent significant bleeding or bleeding tendencies
- Tumor invasion or risk of invasion of major blood vessels that could cause fatal bleeding
- Requirement for drainage of pleural effusion, ascites, or pericardial effusion unless stable after drainage
- Recent arterial or venous thrombosis events
- Known bleeding or clotting disorders
- Recent serious abdominal conditions such as fistula, perforation, or abscess
- Significant vascular disease requiring recent surgery
- Severe or unhealed wounds, active ulcers, or untreated fractures
- Recent major surgery or planned major surgery during the study
- Significant proteinuria
- Recent radiotherapy, chemotherapy, or antibody treatment with incomplete recovery
- Active infection or unexplained fever near treatment start
- Immune dysfunction or active hepatitis B or C infection
- Previous anti-angiogenic therapy
- Other conditions or factors that may affect study results or patient safety as judged by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Medical Unversity Second Hospital
Tianjin, Tianjin Municipality, China, 300211
Actively Recruiting
Research Team
H
Haitao Wang, Ph.D
CONTACT
J
Jinhuan Wang, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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