Status:
RECRUITING
A Modular Multi-Basket Trial to Improve Personalized Medicine in Cancer Patients (Basket of Baskets)
Lead Sponsor:
Vall d'Hebron Institute of Oncology
Collaborating Sponsors:
Roche Pharma AG
Iqvia Pty Ltd
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The global objective of this Basket of Basket study is to evaluate the antitumor activity of each matched therapies that will be evaluated through the study in small molecularly selected populations. ...
Detailed Description
Basket studies are a new sort of clinical studies to identify patients with the same kind of mutations and treat them with the same drug, irrespective of their specific cancer type. In basket studies,...
Eligibility Criteria
Inclusion
- Eligibilty Criteria (PART A - iPROFILER)
- Subjects must have histologically or cytologically confirmed malignancy that is metastatic or unresectable, who have progressed to standard therapy, who are receiving a standard anticancer treatment, but no subsequent approved treatment would be available upon progression, who are unable to receive standard therapy, or for whom standard therapy does not exist.
- Patient must have ECOG performance status of 0 or 1.
- Subjects must be 18-year-old or older.
- Subjects must have measurable disease according to RECIST 1.1.
- Subjects must have enough tumour tissue for molecular analysis.
- Subjects providing formalin-fixed paraffin embedded tissue (FFPE) must provide a minimum amount of tissue ranging from 28 to 36 slides depending on the sample tumour cellularity. If there is not enough archival tissue to meet this criterion, the patient must undergo a tumour biopsy.
- Subjects providing fresh frozen tissue must provide 5 core biopsies or equivalent.
- Fresh frozen tissue must be preferentially collected from a tumour biopsy; hence, subjects must have disease amenable to be biopsied. Otherwise, the patient should have fresh frozen tumour tissue stored in a biobank or biorepository.
- Efforts will be made to provide fresh frozen tissue in at least one quarter of the participating subjects. The proportion of subjects that might provide fresh frozen tissue might change based on the results from the molecular analysis.
- Since some of the tests are performed in FFPE tissue, subjects providing fresh frozen tissue from a recent biopsy will have part of the sample processed in FFPE as per Laboratory manual.
- Subjects must have adequate haematological, renal, and hepatic function.
- For subjects requiring a tumour biopsy: subjects must have adequate coagulation function.
- Subjects must be willing to participate in a clinical trial with a matched therapy according to the molecular profile of his/her tumour.
Exclusion
- Subjects with leptomeningeal disease should be excluded from this clinical trial.
- Subjects with known unstable brain metastases should be excluded from this clinical trial. Exception: Subjects who have undergone surgery and/or radiotherapy and in which brain metastases remain stable or decrease in size for six months after having completed therapy.
- Subjects with spinal cord compression not definitively treated with surgery and/or radiation.
- Subjects with uncontrolled intercurrent illness including, but not limited to, active infection, symptomatic congestive heart failure, LVEF \< 50%, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects with inability to swallow tablets or capsules.
- Subjects with known HIV, hepatitis B or hepatitis C infection.
- Subjects with known history of malabsorption.
- Eligibilty Criteria (PART B - iBASKET)
- Inclusion Criteria:
- Subjects must have metastatic or unresectable malignant tumour, histologically or cytological confirmed and progressing to current therapy. Tumours must be refractory to standard therapy or for which standard therapy does not exist, or subjects may be unable to receive standard therapy.
- Patient must have ECOG performance status of 0 or 1.
- Subjects must be 18-year-old or older.
- Subjects must have measurable disease according to RECIST 1.1.
- Subjects must be willing to participate in a clinical trial with a matched therapy according to the molecular profile of his/her tumour.
- Tumours must harbour the following alterations.
- Subjects must have adequate hematological, renal, and hepatic function.
- For subjects requiring a tumour biopsy: subjects must have adequate coagulation function.
- A woman of childbearing potential must have a negative serum pregnancy test within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy test during the study.
- A woman must be either of the following:
- Not of childbearing potential.
- Of childbearing potential and practicing true abstinence during the entire period of the study, including up to 6 months after the last dose of study treatment is given.
- Of childbearing potential and practicing 2 methods of contraception, including 1 highly effective user independent method and a second method. Participant must agree to continue contraception throughout the study and through 6 months after the last dose of study treatment.
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study treatment.
- A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 6 months after receiving the last dose of study treatment.
- Ability to understand and the willingness to sign a written informed consent document.
Key Trial Info
Start Date :
December 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT03767075
Start Date
December 10 2018
End Date
November 1 2026
Last Update
April 25 2024
Active Locations (8)
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1
Institut Gustave Roussy
Villejuif, France, 94800
2
Deutsches Krebsforschungszentrum (NCT/DKFZ)
Heidelberg, Baden-Wurttemberg, Germany, 69120
3
Universitätsklinikum Dresden
Dresden, Germany, 01307
4
Instituto Nazionale dei Tumori di Milano
Milan, Italy, 20133