Study With Gefitinib in Combination With Olaparib (AZD2281) Versus Gefitinib Alone (GOAL)
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ClinicalTrials.gov Identifier: NCT01513174 |
Recruitment Status :
Completed
First Posted : January 20, 2012
Last Update Posted : April 26, 2017
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Sponsor:
Spanish Lung Cancer Group
Information provided by (Responsible Party):
Spanish Lung Cancer Group
Tracking Information | ||||
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First Submitted Date ICMJE | December 11, 2011 | |||
First Posted Date ICMJE | January 20, 2012 | |||
Last Update Posted Date | April 26, 2017 | |||
Study Start Date ICMJE | August 2011 | |||
Actual Primary Completion Date | July 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
MTD (Maximum Tolerated Dose) defined as the highest dose level at which < 2 out of 6 patients experience a DLT [ Time Frame: 5 weeks ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study With Gefitinib in Combination With Olaparib (AZD2281) Versus Gefitinib Alone | |||
Official Title ICMJE | Multicenter, Randomized, Phase Ib/IIb Study to Evaluate the Efficacy and Tolerability of Gefitinib in Combination With Olaparib (AZD2281) Versus Gefitinib Alone, in Patients With EGFR Mutation Positive Advanced Non-small-cell Lung Cancer | |||
Brief Summary | This is a study of gefitinib plus olaparib gefitinib in combination with olaparib (AZD2281) versus gefitinib alone, in patients with Epidermal Growth Factor Receptor (EGFR) mutation positive advanced non-small-cell lung cancer. | |||
Detailed Description | This is a multicenter, randomized, Phase Ib/IIb, open label study to evaluate the efficacy and tolerability of gefitinib in combination with olaparib (AZD2281) versus gefitinib alone, in patients with Epidermal Growth Factor Receptor (EGFR) mutation positive advanced non-small-cell lung cancer The study will be split into 2 parts: an open label Phase I dose escalation part and a randomized controlled, open label Phase II part. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Non Small Cell Lung Cancer | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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 |
186 | |||
Original Estimated Enrollment ICMJE |
268 | |||
Actual Study Completion Date ICMJE | July 2016 | |||
Actual Primary Completion Date | July 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (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 | Spain | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01513174 | |||
Other Study ID Numbers ICMJE | GECP10-03 2010-024178-21 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Spanish Lung Cancer Group | |||
Study Sponsor ICMJE | Spanish Lung Cancer Group | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Spanish Lung Cancer Group | |||
Verification Date | October 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |