Actively Recruiting
Interventional Study to Evaluate the Combination of Palbociclib + Sunitinib as a Treatment for Advanced Solid Tumors
Led by Rabin Medical Center · Updated on 2025-04-23
100
Participants Needed
1
Research Sites
323 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if a combination of Palbociclib and Sunitinib is safe and effective in various solid tumors. The main questions it aims to answer are: * Is the drugs combination safe for the participants? * Is the drug combination effective in all solid malignancies? It is a single arm study, phase 1b/2, dose escalation and expansion, to determine the safety, tolerability and initial efficacy of this combination. Participants will: * Take the drugs combination every day for 5 executive days, and 2 days of, in a 28 days cycle, for up to a year. * Visit the clinic once every 2 weeks for checkups and tests
CONDITIONS
Official Title
Interventional Study to Evaluate the Combination of Palbociclib + Sunitinib as a Treatment for Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of Stage IV incurable or refractory metastatic solid tumors or locally advanced incurable/refractory tumors
- Tumor types include gastric adenocarcinoma, ovarian epithelial/fallopian tube/primary peritoneal cancer, breast cancer, NSCLC, colorectal cancer, cholangiocarcinoma, pancreatic cancer, carcinosarcoma, high-grade neuroendocrine carcinoma, sarcoma, or other solid tumors
- Failed all other appropriate lines of therapy or refused treatments of choice
- Life expectancy greater than 8 weeks
- ECOG performance status of 0 to 2
- Able to understand and sign informed consent
- Able to adhere to study visit schedule and protocol requirements
- Absolute neutrophil count greater than 1000/mm3 without filgrastim support
- Normal white blood cell count (>3000/mm3)
- Hemoglobin greater than 8.0 g/dL
- Platelet count greater than 80,000/mm3
- Seronegative for HIV antibody
- Documented hepatitis B and C status with controlled HBV DNA if active
- Serum ALT/AST less than three times upper limit of normal or less than five times if liver metastasis present
- Serum creatinine less than or equal to 1.6 mg/dL
- Total bilirubin no more than 1.5 times upper limit of normal (or less than 3 mg/dL if Gilbert's Syndrome)
- Non-pregnant, non-breastfeeding women or women agreeing to avoid pregnancy and breastfeeding during and for at least three months after treatment
- More than 14 days since prior systemic therapy with recovery to Grade 1 or less toxicity except alopecia or vitiligo
- Recovery to Grade 1 or less toxicity after minor surgery or local radiotherapy within past two weeks
You will not qualify if you...
- Known active or recurrent infections including bacterial, viral, fungal, mycobacterial, HIV, or recent major infections requiring hospitalization or antibiotics within 1 week of study start
- History of severe hypersensitivity to study drugs
- Uncontrolled hypertension
- Proteinuria greater than 3 grams per day
- Use of investigational drugs or devices within two weeks before screening
- Active illicit drug use within one month before screening
- Serious psychiatric or psychological disorders
- Significant cardiac, respiratory, or active malignancy comorbidities
- Women of childbearing potential who are pregnant, breastfeeding, or intend to become pregnant or breastfeed during the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Davidoff cancer center, RMC
Petah Tikva, Israel
Actively Recruiting
Research Team
I
Idit Peretz, MD, MBA
CONTACT
S
Salomon M Stemmer, MD, Professor of Medicine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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