Phase 2 Study Assessing Efficacy and Safety of Crizotinib in Patients Harboring an Alteration on ALK, MET or ROS1 (AcSé)
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ClinicalTrials.gov Identifier: NCT02034981 |
Recruitment Status :
Completed
First Posted : January 14, 2014
Last Update Posted : February 28, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | October 16, 2013 | ||||
First Posted Date ICMJE | January 14, 2014 | ||||
Last Update Posted Date | February 28, 2024 | ||||
Actual Study Start Date ICMJE | August 2013 | ||||
Actual Primary Completion Date | June 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
The efficacy of crizotinib as a single agent across diverse type of tumors guided by the presence of identified activating molecular alterations in the crizotinib target genes, per cohort, per pathology, and per target. [ Time Frame: Determined after 8 weeks (2 cycles) of treatment ] Anti-tumor activity of crizotinib, as the primary objective of the trial, will be carried out by the determination of the objective response assessed in each cohort defined by a pathology associated with a crizotinib target alteration.
The objective response is defined as either a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
The objective response after 2 cycles (8 weeks) will be reported to define a success in the 2-stage design.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Phase 2 Study Assessing Efficacy and Safety of Crizotinib in Patients Harboring an Alteration on ALK, MET or ROS1 | ||||
Official Title ICMJE | AcSé CRIZOTINIB : Secured Access to Crizotinib for Patients With Tumors Harboring a Genomic Alteration on One of the Biological Targets of the Drug. | ||||
Brief Summary | This is a biology driven, trans-tumoral, multicentric phase II trial assessing the efficacy and the safety of the targeted agent crizotinib as a monotherapy in 23 cohorts of patients with identified activating molecular alterations in the crizotinib target genes. A cohort is defined by a pathology and a crizotinib-target alteration (eg gastric cancer with MET amplification). For each cohort a two-stage design will be implemented. In the situation where expected accrual allows for a sufficient number of patients to be accrued, the alpha and beta errors will be fixed at 10%. However, in very rare diseases, such as inflammatory myofibroblastic tumor (IMT), neuroblastoma, glioblastoma, and rhabdomyosarcoma (RMS), it is anticipated that the target number may not be achievable in a reasonable timeframe; for these cohorts, the alpha and beta errors will be fixed at 15%. Consequently three different statistical designs will be a priori considered according to the expected response rate and incidence. |
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Detailed Description | Twenty cohorts are identified, a cohort being defined as [one pathology, one target alteration] such as [gastric cancer with MET amplification (6%)]. One cohort will be dedicated to miscellaneous, very rare pediatric diseases identified through INCa platforms or pan-genome programs (e.g. MOSKIDO, IGR) and will recruit up to 10 patients. Two cohorts will be dedicated to a couple of diseases harbouring at least one specific alteration in one crizotinib target, same or different from those listed above, e.g. in AXL gene, arising from pan-genome trials.
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Crizotinib
Patients will receive oral crizotinib, daily continuously, until progression or unacceptable toxicity develops. -250 mg twice daily for adults ≥ 18 years of age
Other Name: XALKORI
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Study Arms ICMJE | Experimental: CRIZOTINIB
All eligible patients entering the study will receive oral crizotinib as monotherapy
Intervention: Drug: Crizotinib
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
246 | ||||
Original Estimated Enrollment ICMJE |
470 | ||||
Actual Study Completion Date ICMJE | December 6, 2023 | ||||
Actual Primary Completion Date | June 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion:
Exclusion :
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Sex/Gender ICMJE |
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Ages ICMJE | 1 Year and older (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02034981 | ||||
Other Study ID Numbers ICMJE | UC-0105/1303 2013-000885-13 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | UNICANCER | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | UNICANCER | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | UNICANCER | ||||
Verification Date | February 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |