Erlotinib in Higher Risk Myelodysplastic Syndrome
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ClinicalTrials.gov Identifier: NCT01085838 |
Recruitment Status
:
Completed
First Posted
: March 12, 2010
Last Update Posted
: November 8, 2016
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Tracking Information | |||||||
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First Submitted Date ICMJE | March 11, 2010 | ||||||
First Posted Date ICMJE | March 12, 2010 | ||||||
Last Update Posted Date | November 8, 2016 | ||||||
Study Start Date ICMJE | July 2010 | ||||||
Actual Primary Completion Date | March 2014 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
The primary objective is to estimate the overall response rate (CR, PR, mCR The primary objective is to estimate the overall response rate (CR, PR, mCR and HI according to the IWG 2000 and 2006 criteria) in patients treated with erlotinib. [ Time Frame: After 12 weeks treatment ] | ||||||
Original Primary Outcome Measures ICMJE |
To determine the maximal dose tolerated (MDT) and dose limiting toxicities (DLTs) [ Time Frame: After 12 weeks treatment ] | ||||||
Change History | Complete list of historical versions of study NCT01085838 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Erlotinib in Higher Risk Myelodysplastic Syndrome | ||||||
Official Title ICMJE | Phase I-II Trial of Erlotinib in Higher Risk Myelodysplastic Syndrome | ||||||
Brief Summary | The aim of this study is to evaluate the toxicity and therapeutic efficacy of erlotinib in high-risk myelodysplastic syndrome (MDS) patients (with at least 10% of bone marrow blasts) ineligible for or having failed intensive chemotherapy and ineligible or after failure of treatment with a hypomethylating agent. | ||||||
Detailed Description | This is a phase I-II multicenter, open label, sequential cohort dose escalation study of erlotinib designed to assess the safety and efficacy of a daily administration of erlotinib in high risk MDS patients. Five patients per cohort will be enrolled into sequential cohorts receiving increasing dosages of erlotinib. The first cohort of 5 patients will start with a dosage of 100 mg erlotinib daily. Response will be determined after 12 weeks of treatment (or earlier upon major hematologic improvement, whichever event occurs first). At the completion of each cohort, defined as the fifth subject completing the week 12 visit, the safety review panel will be responsible for making the decision as to whether the next cohort will begin, an intermediate dose cohort will be added, or if additional subjects will be enrolled into an earlier dose cohort. Upon agreement of the safety review panel, the second cohort of patients will receive 150 mg of erlotinib daily, and - upon agreement of the safety review panel - the third cohort of five patients will be enrolled to receive 300 mg of erlotinib daily. Since it is to be expected that the therapeutically required dosage of erlotinib is higher than the dosage for which a patient was initially enrolled (i.e. patient enrolled in the first cohort receiving 100 mg daily), dosage of erlotinib should be increased (for the same patient) to the next higher level, if no response is documented after 12 weeks of continuous treatment and no grade III or IV toxicity is documented. In contrast, responders will continue their treatment with the same dosage of erlotinib until grade III or IV toxicity arises or treatment loses efficacy (as defined by relapse/progression of the disease). Consequently, this study plans to enrol 15 patients in 3 cohorts of 5 patients. Once the dose limiting toxicity has been defined, additional confirmatory subjects (20) will be enrolled into the appropriate lower dose as recommended by the safety review panel. |
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Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Myelodysplastic Syndrome | ||||||
Intervention ICMJE | Drug: Erlotinib
Erlotinib oral capsule, 100, 150, or 300 mg/day during 12 weeks at study start
Other Name: OSI-774 |
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Study Arms |
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Publications * | Not Provided | ||||||
* 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 |
30 | ||||||
Original Actual Enrollment ICMJE |
35 | ||||||
Actual Study Completion Date | March 2014 | ||||||
Actual Primary Completion Date | March 2014 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||||||
Accepts Healthy Volunteers | 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 | NCT01085838 | ||||||
Other Study ID Numbers ICMJE | GFM-ERLOTINIB-08 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement |
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Responsible Party | Groupe Francophone des Myelodysplasies | ||||||
Study Sponsor ICMJE | Groupe Francophone des Myelodysplasies | ||||||
Collaborators ICMJE | Roche Pharma AG | ||||||
Investigators ICMJE |
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PRS Account | Groupe Francophone des Myelodysplasies | ||||||
Verification Date | March 2013 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |