Status:
RECRUITING
Interventional Study to Evaluate the Combination of Palbociclib + Sunitinib as a Treatment for Advanced Solid Tumors
Lead Sponsor:
Rabin Medical Center
Conditions:
Solid Tumors Refractory to Standard Therapy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 comb...
Detailed Description
Based on the observed in vivo synergistic effects of the Palbociclib and Sunitinib combination on human tumor growth in the PDX models, and the expectation that major pharmacodynamic interactions are ...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Patients with Stage IV incurable/refractory metastatic solid tumors or locally advanced incurable/refractory tumor, who have one of the following tumor types:
- (1) Gastric adenocarcinoma, (2) Ovarian Epithelial, Fallopian Tube, and Primary Peritoneal cancer (FIGO classification), (3) Breast cancer, (4) NSCLC, (5) Colorectal cancer, (6) Cholangiocarcinoma, (7) Pancreatic cancer, (8) Carcinosarcoma (any tissue origin), (9) High grade Neuroendocrine Carcinoma, from any tissue origin, (10) Sarcoma, all histological types, (11) Any other solid tumor.
- Patients who have failed all other appropriate lines of therapy or who have refused treatment(s) of choice
- Life expectancy of greater than 8 weeks
- Clinical performance status of ECOG 0-2
- Able to understand and sign the Informed Consent Form
- Must be able to adhere to the study visit schedule and other protocol requirements.
- Hematology criteria:
- Absolute neutrophils count greater than 1000/mm3 without support of filgrastim Normal WBC (\>3000/mm3). Hemoglobin greater than 8.0 g/dL Platelet count greater than 80,000/mm3
- Serology:
- Seronegative for HIV antibody
- Documented virology status of hepatitis, as confirmed by screening HBV and HCV serology test
- Patients with active HBV must have:
- HBV DNA \< 500 IU/mL obtained within 28 days prior to initiation of study treatment
- received anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to study entry and willingness to continue treatment for the length of the study
- Patients with a history of HCV infection but who are negative for HCV RNA by PCR will be considered non-infected with HCV
- Chemistry:
- Serum ALT/AST less than three times the upper limit of normal (ULN)/ less than five times ULN if liver metastasis present
- Serum creatinine less than or equal to 1.6 mg/dL
- Total bilirubin no more than x1.5 times the ULN, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3 mg/dL.
- Non-pregnant (via negative pregnancy test)/non-breast-feeding women and women with no intention to become pregnant/to breast-feed during the term of the trial and for at least three months after cessation of the P+S treatment
- More than 14 days must have elapsed since any prior systemic therapy before day 1, and patients' toxicities must have recovered to a Grade 1 or less (except for toxicities such as alopecia or vitiligo). Patients may have undergone minor surgical procedures, local radiotherapy with the past two weeks, as long as all toxicities have recovered to Grade 1 or less.
Exclusion
- Inclusion Criteria:
- Age ≥18 years
- Patients with Stage IV incurable/refractory metastatic solid tumors or locally advanced incurable/refractory tumor, who have one of the following tumor types:
- (1) Gastric adenocarcinoma, (2) Ovarian Epithelial, Fallopian Tube, and Primary Peritoneal cancer (FIGO classification), (3) Breast cancer, (4) NSCLC, (5) Colorectal cancer, (6) Cholangiocarcinoma, (7) Pancreatic cancer, (8) Carcinosarcoma (any tissue origin), (9) High grade Neuroendocrine Carcinoma, from any tissue origin, (10) Sarcoma, all histological types, (11) Any other solid tumor.
- Patients who have failed all other appropriate lines of therapy or who have refused treatment(s) of choice
- Life expectancy of greater than 8 weeks
- Clinical performance status of ECOG 0-2
- Able to understand and sign the Informed Consent Form
- Must be able to adhere to the study visit schedule and other protocol requirements
- Hematology:
- Absolute neutrophils count greater than 1000/mm3 without support of filgrastim
- Normal WBC (\>3000/mm3).
- Hemoglobin greater than 8.0 g/dL
- Platelet count greater than 80,000/mm3
- • Serology:
- Seronegative for HIV antibody
- Documented virology status of hepatitis, as confirmed by screening HBV and HCV serology test
- Patients with active HBV must have:
- HBV DNA \< 500 IU/mL obtained within 28 days prior to initiation of study treatment
- received anti-HBV treatment (per local standard of care; e.g., entecavir) for a minimum of 14 days prior to study entry and willingness to continue treatment for the length of the study
- Patients with a history of HCV infection but who are negative for HCV RNA by PCR will be considered non-infected with HCV
- • Chemistry:
- Serum ALT/AST less than three times the upper limit of normal (ULN)/ less than five times ULN if liver metastasis present
- Serum creatinine less than or equal to 1.6 mg/dL
- Total bilirubin no more than x1.5 times the ULN, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3 mg/dL.
- Non-pregnant (via negative pregnancy test)/non-breast-feeding women and women with no intention to become pregnant/to breast-feed during the term of the trial and for at least three months after cessation of the P+S treatment
- More than 14 days must have elapsed since any prior systemic therapy before day 1, and patients' toxicities must have recovered to a Grade 1 or less (except for toxicities such as alopecia or vitiligo). Patients may have undergone minor surgical procedures, local radiotherapy with the past two weeks, as long as all toxicities have recovered to Grade 1 or less.
Key Trial Info
Start Date :
October 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06940349
Start Date
October 21 2021
End Date
January 1 2028
Last Update
April 23 2025
Active Locations (1)
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1
Davidoff cancer center, RMC
Petah Tikva, Israel