Solid Tumors Refractory to Standard TherapyPhase 1/2COPS-01NCT06940349
Interventional Study to Evaluate the Combination of Palbociclib + Sunitinib as a Treatment for Advanced Solid Tumors
A Phase 1/2 study testing Palbociclib and Sunitinib in people with Solid Tumors Refractory to Standard Therapy, run by Rabin Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors Refractory to Standard Therapy
- What is being tested?
- Palbociclib and Sunitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 21 Oct 2021to 1 Jan 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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
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- 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.
- 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:
- 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.
Who cannot join
- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis, atypical mycobacterial disease, and herpes zoster), human immunodeficiency virus (HIV), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) or oral antibiotics within 1 week of day 1
- History of severe immediate hypersensitivity reaction to any of the agents used in this study
- Uncontrolled hypertension
- Proteinuria >3 grams per day
- Subjects who have received any investigational drug or used investigational device within two weeks preceding screening
- Active consumption of illicit drugs within one month preceding screening
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- Serious psychiatric or psychological disorders
- Patients with significant cardiac, respiratory or active malignancy disease comorbidities.
- Women of child-bearing potential who intend to become pregnant or breast-feed or who are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Davidoff cancer center, RMC
Petah Tikva
Idit Peretz, MD,MBA, 972-3-9378002, iditper@clalit.org.il
Salomon M Stemmer, MD, Professor of Medicine, 972-3-9378002, shtemers@clalit.org.il
About this study
Official title: 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
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
Read the 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
- Being tested
- Palbociclib, Sunitinib
- Keywords
- COPS study, phase 1/phase 2 study, combination Palbociclib and Sutent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalbociclibDrug
Palbociclib and Sunitinib
SunitinibDrug
Palbociclib and Sunitinib
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Palbociclib; Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Through study completion, estimated 18 months.
Secondary outcomes (4)
Response rate
To determine the response rate (sum of Complete Response (CR) + Partial Response (PR) for all patients with all indications
Measured: Through study completion, estimated 18 months.
Time to progression
To determine the Time-To-Progression (TTP) for all patients with all indications
Measured: Through study completion, estimated 18 months.
Progression free survival
To determine the Progression-Free Survival (PFS) for all patients with all indications
Measured: Through study completion, estimated 18 months.
Quality of life by EORTC validated questionnaires in all indications, and disease specific indications
To assess the Quality of Life (QoL) via disease-specific questionnaires for all patients with all indications
Measured: Through study completion, estimated 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start21 Oct 2021
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumors Refractory to Standard TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Idit Peretz, Rabin Medical Center
- Investigators
- idit Peretz, MD,MBA, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940349
- Sponsor's protocol ID
- 104420-RMC
- Acronym
- COPS-01
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06940349
- Acronym / sponsor ID
- COPS-01 / 104420-RMC
- Keywords
- COPS study, phase 1/phase 2 study, combination Palbociclib and Sutent
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Palbociclib and Sunitinib combination | Experimental | Drug: Palbociclib, Drug: SunitinibAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (49 listed)
- 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:
- 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
Key exclusion criteria (9 listed)
- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis, atypical mycobacterial disease, and herpes zoster), human immunodeficiency virus (HIV), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) or oral antibiotics within 1 week of day 1
- History of severe immediate hypersensitivity reaction to any of the agents used in this study
- Uncontrolled hypertension
- Proteinuria >3 grams per day
- Subjects who have received any investigational drug or used investigational device within two weeks preceding screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PalbociclibPalbociclib and Sunitinib | Drug | Palbociclib and Sunitinib combination |
| SunitinibPalbociclib and Sunitinib | Drug | Palbociclib and Sunitinib combination |
Primary outcome
Primary safety analysis
Time frame: To be assessed every Disease Monitoring and Safety Board, Every 4 months.
To evaluate the incidence and severity of treatment related adverse events of the Palbociclib and Sunitinib combination using CTCAE v5.0 in all indications
Primary efficacy analysis
Time frame: Through study completion, estimated 18 months.
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.
4 secondary outcomes
Response rate
Time frame: Through study completion, estimated 18 months.
Time to progression
Time frame: Through study completion, estimated 18 months.
Progression free survival
Time frame: Through study completion, estimated 18 months.
Quality of life by EORTC validated questionnaires in all indications, and disease specific indications
Time frame: Through study completion, estimated 18 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Individual participant dataSharing planned: No
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NP137 Clinical and Biological Activities Assessment in Patients With Advanced/Metastatic Solid Tumors Treated by Standard Anti PD-1/PD-L1 Immunotherapies
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
idit Peretz, MD,MBA principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Palbociclib and Sunitinib in people with Solid Tumors Refractory to Standard Therapy, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 49 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Idit Peretz, MD, MBA (972-3-9378002, iditper@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary safety analysis (time frame: To be assessed every Disease Monitoring and Safety Board, Every 4 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.