Colorectal cancer and non-small cell lung cancer
Conditions
Interventions
Product Name: Palbociclib
Product Code: PD-0332991
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: PD-0332991
CAS Number: 571190
Sponsors
Antoni van Leeuwenhoek - Netherlands Cancer Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with locally advanced (incurable) or metastatic colorectal cancer or NSCLC that have only one line standard of care treatment left, or will start with a study treatment. Patients should have received a first line standard of care treatment. 2. Patients for whom treatment with curative intent is not an option 3. RECIST 1.1 evaluable metastatic or locally advanced lesion(s). 4. Metastatic or locally advanced lesion(s) of which a histological biopsy can safely be obtained 5. Adequate kidney and liver function. 6. WHO performance status 0-1 7. Informed consent 8. 18 years or older Additional in- and exclusion criteria are provided for each experimental compound Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating (nursing) women 2. Prior malignancy within 5 years. Patients with a history of non-melanomatous skin cancer, successfully treated carcinoma in situ or with a disease free period of > 5 years may be included. 3. Known infection with human immunodeficiency virus (HIV). 4. Leptomeningeal carcinomatosis. 5. Symptomatic brain metastasis. Patients that are asymptomatic and have been stable for 3 months (confirmed by MRI/CT scan) are eligible for participation if they are not receiving corticosteroid therapy or anti-epileptic drugs. 6. Other psychiatric or medical conditions that would make the patient unfit for participation due to an increase in the risk associated with study participation or incompliance with study procedures. 7. Life expectancy of less than 3 months from tumor progression under standard of care. Additional in- and exclusion criteria are provided for each experimental compound
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of patient-derived tumor organoids to successfully allocate patients for treatment with specific targeted agents. ;Secondary Objective: Characterize safety and tolerability of each experimental agent. ;Primary end point(s): Overall clinical response rate (ORR) according to RECIST 1.1.;Timepoint(s) of evaluation of this end point: Continuous, every 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: PFS and ORR: every 2 months Incidence and severity of adverse events: every week for the first cycle, every other week for subsequent cycles ; Secondary end point(s): • Progression free survival (PFS) per RECIST 1.1. • Progression free survival per RECIST 1.1 per compound or combination of compounds. • Overall response rate (ORR) per RECIST 1.1 per compound or combination of compounds. • Incidence and severity of adverse events per compound or combination of compounds. | — |
Countries
Netherlands
Contacts
Public ContactFleur Weeber
Antoni van Leeuwenhoek - Netherlands Cancer Institute
Outcome results
None listed