Until recently, clinical trials investigating cancer drugs have been conducted separately for different tumour location and histological types because they were the primary known determinant of drug efficacy. With the development of therapies targeting genomic alterations in tumour cells, novel clinical development strategies are necessary. Indeed, the genomic alteration can be uncommon in one particular tumour type and can be shared by several tumour types. Basket trials typically include patients with diverse tumour types sharing one distinguishing feature (i.e. one single or one class of biological alterations). Patients are then assigned to a drug expected to be active for tumours that harbour that alteration [
- Hyman D.M.
- Puzanov I.
- Subbiah V.
- Faris J.E.
- Chau I.
- Blay J.-Y.
- et al.
Vemurafenib in multiple nonmelanoma cancers with BRAF V600 mutations.
N Engl J Med. 2015; 373: 726-736
- Slosberg E.D.
- Kang B.P.
- Peguero J.
- Taylor M.
- Bauer T.M.
- Berry D.A.
- et al.
Signature program: a platform of basket trials.
Oncotarget. 2018; 9: 21383-21395
- Redig A.J.
- Jänne P.A.
Basket trials and the evolution of clinical trial design in an era of genomic medicine.
J Clin Oncol. 2015; 33: 975-977https://doi.org/10.1200/JCO.2014.59.8433
To read this article in full you will need to make a payment
Purchase one-time access:Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
One-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:Subscribe to European Journal of Cancer
Already a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
- Vemurafenib in multiple nonmelanoma cancers with BRAF V600 mutations.N Engl J Med. 2015; 373: 726-736
- Signature program: a platform of basket trials.Oncotarget. 2018; 9: 21383-21395
- Basket trials and the evolution of clinical trial design in an era of genomic medicine.J Clin Oncol. 2015; 33: 975-977https://doi.org/10.1200/JCO.2014.59.8433
- First-line crizotinib versus chemotherapy in ALK -positive lung cancer.N Engl J Med. 2014; 371: 2167-2177
- Inflammatory myofibroblastic tumors harbor multiple potentially actionable kinase fusions.Cancer Discov. 2014; 4: 889-895
- Comprehensive molecular characterization of papillary renal-cell carcinoma.N Engl J Med. 2016; 374: 135-145
- TFE3 fusions activate MET signaling by transcriptional up-regulation, defining another class of tumors as candidates for therapeutic MET inhibition.Cancer Res. 2007; 67: 919-929
- Identification of the receptor tyrosine kinase c-met and its ligand, hepatocyte growth factor, as therapeutic targets in clear cell sarcoma.Cancer Res. 2010; 70: 639-645
- Validation of met as a therapeutic target in alveolar and embryonal rhabdomyosarcoma.Cancer Res. 2006; 66: 4742-4749
- Crizotinib in patients with advanced, inoperable inflammatory myofibroblastic tumours with and without anaplastic lymphoma kinase gene alterations (European Organisation for Research and Treatment of Cancer 90101 CREATE): a multicentre, single-drug, prospective, non-randomised phase 2 trial.Lancet Respir Med. 2018; 6: 431-441
- The tyrosine kinase inhibitor crizotinib does not have clinically meaningful activity in heavily pre-treated patients with advanced alveolar rhabdomyosarcoma with FOXO rearrangement: european Organisation for Research and Treatment of Cancer phase 2 trial 90101 “CREATE”.Eur J Cancer. 2018; 94: 156-167
- Activity and safety of crizotinib in patients with alveolar soft part sarcoma with rearrangement of TFE3: european Organization for Research and Treatment of Cancer (EORTC) phase II trial 90101 “CREATE”.Ann Oncol. 2018; 29: 758-765
- Activity and safety of crizotinib in patients with advanced clear-cell sarcoma with MET alterations: european Organization for Research and Treatment of Cancer phase II trial 90101 “CREATE”.Ann Oncol. 2017; 28: 3000-3008
- Crizotinib achieves long-lasting disease control in advanced papillary renal-cell carcinoma type 1 patients with MET mutations or amplification. EORTC 90101 CREATE trial.Eur J Cancer. 2017; 87: 147-163
- Optimal two-stage designs for phase II clinical trials.Contr Clin Trials. 1989; 10: 1-10
- Progression-free rate as the principal end-point for phase II trials in soft-tissue sarcomas.Eur J Cancer. 2002; 38: 543-549
Published online: January 14, 2019
Accepted: December 13, 2018
Received: November 29, 2018
© 2018 Elsevier Ltd. All rights reserved.