A Phase 1b Study Evaluating GS-9820 in Subjects With Lymphoid Malignancies
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|ClinicalTrials.gov Identifier: NCT01705847|
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : May 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Lymphoid Malignancies||Drug: GS-9820||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GS-9820 in Subjects With Lymphoid Malignancies|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
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 tablets containing 200 mg of GS-9820 administered orally
Other Name: CAL-120
- Maximum tolerated dose (MTD) [ Time Frame: Up to 4 weeks ]MTD will be assessed to determine the appropriate dosing regimens for use in future clinical trials of GS-9820 in subjects with lymphoid malignancies.
- Overall safety [ Time Frame: Up to 5 years ]Overall safety will be assessed by overall safety profile, enumeration and description of any dose-limiting toxicities, serious adverse events, or adverse events leading to discontinuation of study drug.
- Pharmacokinetic parameters of GS-9820 as measured by Cmax, Tmax, Ctrough, and AUC [ Time Frame: Baseline to Day 29 ]
- Cmax is defined as the maximum concentration of drug
- Tmax is defined as the time of Cmax
- Ctrough is defined as the trough concentration
- AUC is defined as the area under the plasma concentration versus time curve
- Pharmacodynamics to measure changes in the phosphatidylinositol 3-kinase (P13K) delta pathway activation and changes in plasma concentration of disease-associated chemokines and cytokines [ Time Frame: Baseline to Day 29 ]
- Tumor control [ Time Frame: Up to 5 years ]Tumor control as assessed by overall response rate (ORR), time to response (TTR), duration of response (DOR), progression-free survival (PFS), percent change in lymph node area, lymph node response rate, splenomegaly response rate, ALC response rate, hepatomegaly response rate, platelet response rate, hemoglobin response rate, and neutrophil response rate.
- Patient well-being assessed using changes in baseline in HRQL (health related quality of life questionnaire) domain and symptom scores based on the Functional Assessment of Cancer Therapy: Lymphoma (FACT-Lym) [ Time Frame: Up to 5 years ]
- Drug exposure [ Time Frame: Up to 5 years ]Drug administration for GS-9820 as assessed by prescribing records and GS-9820 compliance as assessed by quantification of used and unused drug.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705847
|VU Medical Center (VUmc)|
|Amsterdam, Netherlands, 1081 HV|
|Academic Medical Center|
|Amsterdam, Netherlands, 1105 AZ|
|St. Antonius Hospital|
|Nieuwegein, Netherlands, 3435 CM|
|Erasmus MC - Daniel den Hoed Cancer Center|
|Rotterdam, Netherlands, 3075 EA|
|Study Director:||Henry Adewoye, MD||Gilead Sciences|