NCT06940349

Interventional Study to Evaluate the Combination of Palbociclib + Sunitinib as a Treatment for Advanced Solid Tumors

A Phase 1b/2 Open Label, Dose Escalating, Single Center Study to Evaluate the Safety, Tolerability and Initial Efficacy of Palbociclib + Sunitinib Oral Kinase Inhibitor Combination as a Treatment for Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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

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 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

Conditions

• Solid Tumors Refractory to Standard Therapy

Interventions

Type	Name	Description
DRUG	Palbociclib	Palbociclib and Sunitinib
DRUG	Sunitinib	Palbociclib and Sunitinib

Timeline

• Start date: 2021-10-21
• Primary completion: 2026-01-01
• Completion: 2028-01-01
• First posted: 2025-04-23
• Last updated: 2025-04-23

Locations

1 site across 1 country: Israel

Regulatory

• FDA-regulated drug study