This study has been transitioned to CTIS with ID 2024-514238-19-00 check the CTIS register for the current data. The general purpose of the study is to find personalized cancer treatment based on genetic analysis of tumors.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
advanced solid tumor
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Module 1 & 2: • Overall response rate (ORR) or complete response (CR) by RECIST 1.1 of different targeted agents in molecularly selected small patient populations. No specific primary endpoint in iProfiler (Part A) protocol.
Secondary outcome
Specific Secondary Endpoints for iProfiler part
•To determine the prevalence of genetic alterations in the iPROFILER screened
population
• Progression free survival (PFS by RECIST 1.1) of the patients treated with
each investigational agent evaluated at the end of the module.
• Progression Free Survival (PFS by RECIST 1.1) at 6 months of subjects treated
with targeted therapy with each investigational agent.
• Overall survival (OS) of subjects treated with each investigational agent
evaluated at the end of the module.
- Incidence and severity of adverse events (AEs) in subjects receiving each
investigational agent.
Specific Secondary Endpoints for Module 2:
• Duration of response (CR or PR), calculated from the date of initial
documentation of a response to the date of first documented evidence of
progressive disease (or relapse for subjects who experience CR during the
study) or death. Data from subjects who are progression-free and alive or have
unknown status will be censored at the last tumour
assessment.
Background summary
Basket studies are a new sort of medical scientific studies to identify
subjects with the same kind of mutations and treat them with the same drug,
irrespective of their specific cancer type. In basket studies, depending on the
mutation types, subjects are classified into *baskets*. Therapies that block
that mutation (targeted therapies) are then identified and those therapies are
assigned to subjects in the different groups.
Study objective
This study has been transitioned to CTIS with ID 2024-514238-19-00 check the CTIS register for the current data.
The general purpose of the study is to find personalized cancer treatment based
on genetic analysis of tumors.
Study design
Basket of Baskets is a medical scientific study that has two parts.
Part A (I-Profiler) is the portion of the study in which the tumour tissue is
analysed for the mutations associated with the tumour. This will be performed
through a laboratory test to find out if the tumour carries any mutation(s)
that could be a target for specific drug therapy.
Part B (I-Basket) is the therapeutic part. In this part, we will study the
effect of a specific treatment for patients with the same kind of mutation
found in their tumours.
Intervention
Atezolizumab will be given by slow intravenous infusion (1200mg), every 3
weeks.
All subjects in the iBasket Module 2 study will be given an oral dose of 20 mg
of futibatinib once daily (five tablets a day).
Study burden and risks
Atezolizumab has been tested in people with various forms of cancer and is
generally well tolerated. Side effects can vary from mild to very severe and
can vary from person to person. Everyone who participates in the study is
closely monitored for any side effects.Atezolizumab may cause side effects.
The following side effects are very common (occur in more than 1 in 10 people
or more): Fatigue, Joint pain (arhralgia), Lack of energy (asthenia), Decreased
appetite, Diarrhea, Shortness of breath (dyspnea), Urinary tract infection,
Cough, Itching of the skin, Nausea, Fever, Rash, Vomiting, Muscle and bone pain
(myalgia, musculoskeletal pain and bone pain), and headache. In rare
situations, an activation of immune system can occur with administration of
atezolizumab.
The following side effects associated with futibatinib are very common (occurs
in more than 10% of subjects):
• Increased blood levels of phosphate. This may result in muscle cramps,
numbness, or tingling around the mouth, but most subjects have no symptoms
• Nail disorders. These might include: separation of the nail from the skin
below, shedding of the nails, change in nail color, infection of the soft
tissue around a fingernail or pain in the nail.
• Diarrhea
• Tiredness and lack of energy
• Hair loss
• Increased blood level of liver enzymes. This can be a possible sign of
inflammation or damage to the liver
• Dry mouth
• Dry skin
• Inflammation of the mouth
• Nausea
• Swelling and redness of the skin on the palms of the hands and soles of the
feet
• Constipation
• Reduced desire to eat
• Changes in taste
• Dry eye
Carrer Natzaret Cellex Building, 115-117
Barcelona 08035
ES
Carrer Natzaret Cellex Building, 115-117
Barcelona 08035
ES
Listed location countries
Age
Inclusion criteria
Part A: 1. 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. 2. Subjects must have ECOG performance status of 0 or 1. 3. Subjects must be 18 year-old or older. 4. Subjects must have measurable disease according to RECIST 1.1. 5. 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 20 to 28 slides depending on the sample tumour cellularity. If there is not enough archival tissue to meet this criterion, the subject must undergo a tumour biopsy. • Subjects providing fresh frozen tissue (FFT) must provide 4 core biopsies or equivalent. FFT must be preferentially collected from a tumour biopsy; hence, patients must have disease amenable to be biopsied. Otherwise, the subject should have FFT stored in a biobank or biorepository. • Efforts will be made to provide FFT in at least one quarter of the participating subjects. The proportion of subjects that might provide FFT might change based on the results from the molecular analysis. • Since some of the tests are performed in FFPE tissue, patients providing FFT from a recent biopsy will have part of the sample processed in FFPE tissue as per Laboratory manual. 6. Subjects must have adequate hematological function: absolute granulocyte count >= 1.5 × 109/L, platelet count >= 100 × 109/L. 7. Subject must have adequate renal and hepatic function: creatinine clearance >= 30ml/min, serum bilirubin <= 1.5 × ULN; unless due to Gilbert's syndrome, AST/ALT <= 5 × ULN if liver metastases are present or AST/ALT <= 3 × ULN if the subject has no liver involvement. 8. For subjects requiring a tumor biopsy: patients must have adequate coagulation function quick time >= 60% or INR <= 1.5 9. Subjects must be willing to participate in a clinical trial with a matched therapy according to the molecular profile of his/her tumor 10. Ability to understand and the willingness to sign a written informed consent document. Part B: Inclusion criterion 2/3/4/6/8/9/10/12 from part A 1. 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 tumours for which standard therapy does not exist, or subjects may be unable to receive standard therapy. 2. Subjects must have adequate renal and hepatic function: • Serum creatinine <= 1.5 × ULN or creatinine clearance >= 30 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation: (140 * age) × (weight in kg) × (0.85 if female)/72 × (serum creatinine in mg/dL) • Serum bilirubin <= 1.5 × ULN; with the following exception: subjects with known Gilbert disease who have serum bilirubin level <= 3 × ULN may be enrolled •AST, ALT, and alkaline phosphatase < 2.5 x ULN, with the following exceptions: oPatients with documented liver metastases: AST and ALT < 5 x ULN oPatients with documented liver or bone metastases: alkaline phosphatase < 5 x ULN 3. Subjects receiving therapeutic anticoagulation (such as low*molecular weight heparin or warfarin) should be on a stable dose 4. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of <1% per year (when used consistently and correctly) during the treatment period and for at least 5 months after the last dose of atezolizumab / 6 months after the last dose of Futibatinib, in case of being included in Part B of the study. Please see protocol for more details. 5.For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined in the protocol. (Please refer to section 3.1 Inclusion Criteria of iProfiler, Module 1 and 2 for full list)
Exclusion criteria
Part A: 1.Subjects with leptomeningeal disease 2. 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 3.Subjects with spinal cord compression not definitively treated with surgery and/or radiation 4.Subjects with uncontrolled intercurrent illness 5.Subjects with inability to swallow tablets or capsules 6.Subjects with known HIV, hepatitis B or hepatitis C infection 7.Subjects with known history of malabsorption Part B: 1.Pregnant or breastfeeding women. Females of childbearing potential must have a negative serum pregnancy test within 14 days prior to Day 1. This negative test will be valid for Cycle 1 day 1. In subsequent cycles, serum pregnancy test will be performed on day 1 of each cycle, with a +/- 3 day window, and prior to drug administration. 2.Any approved anticancer therapy within 3 weeks prior to initiation of study treatment. Exception: hormone-replacement therapy or oral contraceptives; Somatostatin analogues for the treatment of symptoms related with neuroendocrine tumours, gonadotropin-releasing hormone agonists or antiandrogens for prostate cancer. - Palliative radiotherapy for bone metastases > 2 weeks prior to Cycle 1, Day 1. 3.Major surgical procedure within 28 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the study 4.Treatment with an investigational agent within 4 weeks prior to Cycle 1, Day 1 (or within five half-lives of the investigational product, whichever is longer), with the exception of monoclonal antibodies (4 week wash-out period) 5.Subjects with known unstable brain metastases. Exception: treated brain metastasis which remain stable or responding 6 weeks after completing radiotherapy 6.Uncontrolled intercurrent illness that would limit compliance with study requirements 7.Subjects with active hepatitis B (HBV) or hepatitis C (HCV). Subjects with past HBV infection or resolved HBV infection are eligible. Subjects positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA 8.Significant cardiovascular disease within 3 months prior to Cycle 1, Day 1, unstable arrhythmias or unstable angina. 9.Another primary malignancy other than disease under study within 2 years prior to Cycle 1 Day 1, unless consider at low risk of relapse at Investigator discretion. 10.History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, fusion proteins or any excipient of the experimental product. 11.Prior allogeneic bone marrow transplantation or prior solid organ transplantation 13.Administration of a live, attenuated vaccine within 4 weeks prior to Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study. Influenza vaccination can be given during influenza season only but patients must not receive live, attenuated influenza vaccine within 4 weeks prior to Cycle 1, Day 1 or at any time during the study 14.History of active tuberculosis 15.Contraindications included in the product information of the drugs used in the study. Please refer to section 3.2 Exclusion Criteria for full list of iProfiler, Module 1 and 2.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EU-CTR | CTIS2024-514238-19-00 |
EudraCT | EUCTR2017-005108-89-NL |
CCMO | NL65937.031.18 |