Status and phase
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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:
Participants will:
Full 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 not expected, the Investigator initiated a Phase 1b/2 study to evaluate the safety, tolerability and initial efficacy of Palbociclib + Sunitinib oral kinase inhibitor combination as a treatment for advanced solid tumors.
The study population will include 20-100 patients with documented Stage IV, incurable/refractory metastatic solid tumors of the following types whom have failed at least one standard course of therapy: (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 and (8) Carcinosarcoma, any tissue origin.
(9) High grade Neuroendocrine Carcinoma, from any tissue origin. (10) Sarcoma, all histological types. (11) Any other solid tumor.
All patients will be administered 25 mg S:75 mg P, both once daily for 5 consecutive days and 2 days off schedule for the first week and then the dose can be escalated to 37.5 mg S:75 mg P, Both once daily for 5 consecutive days and 2 days off schedule per week. From the second week onwards, dose can be escalated to 37.5 mg S:75 mg P, Both once daily for 7 consecutive days, per physician discretion. Sunitinib dose will be evaluated in each clinic visit, dose can be adjusted to alternately 37.5mg/25mg or be reduced to 25 mg daily, by patient tolerance and adverse events.
Both drugs will be administered by mouth, taken together with food
Enrollment
Sex
Ages
Volunteers
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 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
Exclusion criteria
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.
Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
100 participants in 1 patient group
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Central trial contact
Idit Peretz, MD, MBA; Salomon M Stemmer, MD, Professor of Medicine
Data sourced from clinicaltrials.gov
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