Study of Olaparib and Temozolomide in Patients With Recurrent Small Cell Lung Cancer Following Failure of Prior Chemotherapy
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ClinicalTrials.gov Identifier: NCT02446704 |
Recruitment Status : Unknown
Verified January 2022 by Zofia Piotrowska, Massachusetts General Hospital.
Recruitment status was: Active, not recruiting
First Posted : May 18, 2015
Last Update Posted : February 7, 2022
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Tracking Information | ||||
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First Submitted Date ICMJE | May 14, 2015 | |||
First Posted Date ICMJE | May 18, 2015 | |||
Last Update Posted Date | February 7, 2022 | |||
Actual Study Start Date ICMJE | October 13, 2015 | |||
Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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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 | Study of Olaparib and Temozolomide in Patients With Recurrent Small Cell Lung Cancer Following Failure of Prior Chemotherapy | |||
Official Title ICMJE | Phase I/II Study of Olaparib and Temozolomide in Patients With Recurrent Small Cell Lung Cancer Following Failure of Prior Chemotherapy | |||
Brief Summary | This research study is evaluating the combination of olaparib and temozolomide as a possible treatment for Small Cell Lung Cancer. | |||
Detailed Description | This research study is a Phase I/II clinical trial, which has two parts. The participant will be asked to participate in one part of the study. The first part tests the safety of the combination of drugs and tries to define the appropriate dose to use for future studies. The second part tests whether the combination of drugs is effective in treating small cell lung cancer. "Investigational" means that the combination of drugs is being studied. It also means that the U.S. Food and Drug Administration (FDA) has not approved the combination of drugs for Small Cell Lung Cancer. Olaparib (Lynparza) is FDA approved for the treatment of a type of ovarian cancer associated with a particular DNA change. Olaparib works by blocking the activity of a protein called poly (ADP-ribose) polymerase (PARP) which is involved in DNA repair. Cancer cells rely on PARP to repair their DNA and enable them to continue dividing. Olaparib has been used in research studies with other cancers. Information from those other research studies suggests that this drug may help to treat patients with small cell lung cancer. While it is not approved by the FDA for small cell lung cancer, it is considered part of standard treatment for other cancer. Temozolomide (Temodar) is approved by the FDA for the treatment of a type of brain tumor, glioblastoma. It has been studied in small cell lung cancer in previous research studies. While it is not approved by the FDA for small cell lung cancer, it is considered part of standard treatment for relapsed disease. In this research study, the investigators are looking for the maximum tolerated dose or MTD of the combination of olaparib and temozolomide that can be given safely. The investigators will also begin to collect information about the effects of the combination on small cell lung cancer |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Small Cell Lung Cancer | |||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Olaparib and Temozolomide
- Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. Once the MTD is determined, the study will move to the phase II portion.
Interventions:
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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 | Unknown status | |||
Actual Enrollment ICMJE |
66 | |||
Original Estimated Enrollment ICMJE |
38 | |||
Estimated Study Completion Date ICMJE | December 2023 | |||
Estimated Primary Completion Date | December 2022 (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 | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02446704 | |||
Other Study ID Numbers ICMJE | 15-121 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Zofia Piotrowska, Massachusetts General Hospital | |||
Original Responsible Party | Anna Farago, Massachusetts General Hospital, MD, PhD | |||
Current Study Sponsor ICMJE | Zofia Piotrowska | |||
Original Study Sponsor ICMJE | Massachusetts General Hospital | |||
Collaborators ICMJE | AstraZeneca | |||
Investigators ICMJE |
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PRS Account | Massachusetts General Hospital | |||
Verification Date | January 2022 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |