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

NCT06940349 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 104420-RMC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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

Solid Tumors Refractory to Standard Therapy

Keywords

COPS study; phase 1/phase 2 study; combination Palbociclib and Sutent

Outcome Measures

Primary Outcomes (2)

• Primary safety analysis

  To evaluate the incidence and severity of treatment related adverse events of the Palbociclib and Sunitinib combination using CTCAE v5.0 in all indications

  To be assessed every Disease Monitoring and Safety Board, Every 4 months.

• Primary efficacy analysis

  To determine the percentage of Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progression of Disease (PD) via RECIST criteria, based on the results of the imaging studies. Imaging studies will be carried out at Screening and every two months after treatment initiation.

  Through study completion, estimated 18 months.

Secondary Outcomes (4)

• Response rate

  Through study completion, estimated 18 months.

• Time to progression

  Through study completion, estimated 18 months.

• Progression free survival

  Through study completion, estimated 18 months.

• Quality of life by EORTC validated questionnaires in all indications, and disease specific indications

  Through study completion, estimated 18 months.

Study Arms (1)

Palbociclib and Sunitinib combination

EXPERIMENTAL

All patients will be administered Sunitinib (S) 25 mg + Palbociclib (P) 75 mg, both once daily for 5 consecutive days and 2 days off schedule for the first week and then the dose can be escalated to S 37.5 mg + P 75 mg, Both once daily for 5 consecutive days and 2 days off schedule per week. From the second week onwards, dose can be escalated to S 37.5 mg + P 75 mg, Both once daily for 7 consecutive days, per physician discretion.

Drug: Palbociclib; Drug: Sunitinib

Interventions

Palbociclib DRUG

Palbociclib and Sunitinib

Palbociclib and Sunitinib combination

Sunitinib DRUG

Palbociclib and Sunitinib

Palbociclib and Sunitinib combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Davidoff cancer center, RMC

Petah Tikva, Israel

RECRUITING

MeSH Terms

Interventions

palbociclib; Sunitinib

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• idit Peretz, MD,MBA

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Idit Peretz, MD, MBA

CONTACT

972-3-9378002; iditper@clalit.org.il

Salomon M Stemmer, MD, Professor of Medicine

CONTACT

972-3-9378002; shtemers@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 23, 2025
• Study Start: October 21, 2021
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)