Ignite Creation Date:
2024-05-06 @ 1:32 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01831726
Status:
COMPLETED
Last Update Posted:
2017-03-20
First Post:
2013-04-11
Brief Title:
Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Modular Phase II Study to Link Targeted Therapy to Patients With Pathway Activated Tumors Module 2 - Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib Including Tumors With Mutations or Translocations of FGFR PDGFR VEGF cKIT FLT3 CSFR1 Trk and RET
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIGNATURE
Brief Summary:
The purpose of this signal seeking study was to determine whether treatment with dovitinib TKI258 demonstrated sufficient efficacy in select pathway-activated solid tumors andor hematologic malignancies to warrant further study
Detailed Description:
This was a phase II open label study to determine the efficacy and safety of treatment with dovitinib TKI258 in patients with a diagnosis of select solid tumors or hematological malignancies that have been pre-identified prior to study consent to have mutations translocations or amplifications and whose disease has progressed on or after standard treatment
Genomic profiling is becoming more accessible to patients and their physicians As such more patients have been identified with potentially-actionable mutations translocations or amplifications but do not have access to targeted drug treatment This is a signal-seeking study to match patients with tumor pathway activations inhibited by dovitinib to the RTK inhibitor dovitinib Pre-identification of mutations translocations or amplifications will be performed locally at a CLIA certified laboratory prior to participation on the trial
For the purpose of this study genomic profiling is not considered part of screening Informed consent must be signed before any screening activities take place Once eligibility screening criteria met has been confirmed by Novartis the patient will initiate therapy with dovitinib single-agent The patient may not receive any additional anti-cancer therapy during treatment with dovitinib
Patients received study treatment until disease progression assessed by investigator per RECIST 11 or appropriate hematologic response criteria unacceptable toxicity death or discontinuation from study treatment for any other reason eg withdrawal of consent start of a new anti-neoplastic therapy or at the discretion of the investigator otherwise known as End of Treatment All patients who discontinue from study treatment due to disease progression must have their progression clearly documented
Disease assessment by RECIST 11 or appropriate hematological response criteria will be performed every 8 weeks 4 days after first dose of study drug Day 1 of every odd cycle until disease progression or end of treatment whichever occurs first The frequency of disease assessment may be reduced to every 12 weeks for patients who have at least 4 post-baseline disease assessments and are clinically stable except AML patients Scans was assessed locally by the investigator After discontinuation of treatment patients regardless of reason for treatment discontinuation will be followed for safety for 30 days after the last dose
All patients will be followed for survival status every 3 months for 2 years after the last patient has enrolled in the studyregardless of treatment discontinuation reason except if consent is withdrawn or patient is lost to follow-up
Genomic profiling is becoming more accessible to patients and their physicians As such more patients have been identified with potentially-actionable mutations translocations or amplifications but do not have access to targeted drug treatment This is a signal-seeking study to match patients with tumor pathway activations inhibited by dovitinib to the RTK inhibitor dovitinib Pre-identification of mutations translocations or amplifications will be performed locally at a CLIA certified laboratory prior to participation on the trial
For the purpose of this study genomic profiling is not considered part of screening Informed consent must be signed before any screening activities take place Once eligibility screening criteria met has been confirmed by Novartis the patient will initiate therapy with dovitinib single-agent The patient may not receive any additional anti-cancer therapy during treatment with dovitinib
Patients received study treatment until disease progression assessed by investigator per RECIST 11 or appropriate hematologic response criteria unacceptable toxicity death or discontinuation from study treatment for any other reason eg withdrawal of consent start of a new anti-neoplastic therapy or at the discretion of the investigator otherwise known as End of Treatment All patients who discontinue from study treatment due to disease progression must have their progression clearly documented
Disease assessment by RECIST 11 or appropriate hematological response criteria will be performed every 8 weeks 4 days after first dose of study drug Day 1 of every odd cycle until disease progression or end of treatment whichever occurs first The frequency of disease assessment may be reduced to every 12 weeks for patients who have at least 4 post-baseline disease assessments and are clinically stable except AML patients Scans was assessed locally by the investigator After discontinuation of treatment patients regardless of reason for treatment discontinuation will be followed for safety for 30 days after the last dose
All patients will be followed for survival status every 3 months for 2 years after the last patient has enrolled in the studyregardless of treatment discontinuation reason except if consent is withdrawn or patient is lost to follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None