A Phase 1b Study Evaluating GS-9820 in Subjects With Lymphoid Malignancies
NCT ID: NCT01705847
Last Updated: 2016-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
39 participants
INTERVENTIONAL
2012-11-30
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GS-9820
Participants will be sequentially enrolled at progressively higher dose levels to receive GS-9820 administered twice a day. Escalation will proceed to the maximum tolerated dose (MTD), defined as the highest tested dose associated with a rate of dose-limiting toxicities (DLT) of \< 33% during the first 4 weeks of therapy.
GS-9820
GS-9820 tablets containing 200 mg of GS-9820 administered orally
Interventions
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GS-9820
GS-9820 tablets containing 200 mg of GS-9820 administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable lymphadenopathy
* Requires therapy
Exclusion Criteria
* Evidence of ongoing infection
* Concurrent participation in another therapeutic clinical trial
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Henry Adewoye, MD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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VU Medical Center (VUmc)
Amsterdam, , Netherlands
Academic Medical Center
Amsterdam, , Netherlands
St. Antonius Hospital
Nieuwegein, , Netherlands
Erasmus MC - Daniel den Hoed Cancer Center
Rotterdam, , Netherlands
Countries
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Other Identifiers
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2012-000360-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-315-0102
Identifier Type: -
Identifier Source: org_study_id
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