Interventional Study to Evaluate the Combination of Palbociclib + Sunitinib as a Treatment for Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRabin Medical Center
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
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
Disqualifiers
Age ≥18 years
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
Trial design
Design model
Single group
Treatments tested in this trial
Palbociclib
DrugPalbociclib and Sunitinib
Sunitinib
DrugPalbociclib and Sunitinib
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Palbociclib and Sunitinib combinationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
To be assessed every Disease Monitoring and Safety Board, Every 4 months.2
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.
Time frame
Through study completion, estimated 18 months.Secondary outcomes
1
Response rate
To determine the response rate (sum of Complete Response (CR) + Partial Response (PR) for all patients with all indications
Time frame
Through study completion, estimated 18 months.2
Time to progression
To determine the Time-To-Progression (TTP) for all patients with all indications
Time frame
Through study completion, estimated 18 months.3
Progression free survival
To determine the Progression-Free Survival (PFS) for all patients with all indications
Time frame
Through study completion, estimated 18 months.4
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
Time frame
Through study completion, estimated 18 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov