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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
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
This study is to determine the appropriate dosing regimen of GS-9820 in subjects with lymphoid malignancies. This is a Phase 1b, open-label, dose-escalation and expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of GS-9820.

Condition or disease Intervention/treatment Phase
Lymphoid Malignancies Drug: GS-9820 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: 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.
Drug: GS-9820
GS-9820 tablets containing 200 mg of GS-9820 administered orally
Other Name: CAL-120




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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 ]
  4. 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.

  5. 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 ]
  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previously treated recurrent B-cell iNHL, DLBCL, MCL, HL or CLL
  • Measurable lymphadenopathy
  • Requires therapy

Exclusion Criteria:

  • Recent history of a major non-lymphoid malignancy
  • Evidence of ongoing infection
  • Concurrent participation in another therapeutic clinical trial

Information from the National Library of Medicine

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


Locations
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Netherlands
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
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Henry Adewoye, MD Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01705847     History of Changes
Other Study ID Numbers: GS-US-315-0102
2012-000360-19 ( EudraCT Number )
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 2016
Keywords provided by Gilead Sciences:
chronic lymphocytic leukemia (CLL)
non-Hodgkin lymphoma (NHL)
Hodgkin lymphoma (HL)
indolent non-Hodgkin lymphoma (iNHL)
diffuse large B-cell lymphoma-activated B-cell (DLBCL-ABC)
DLBCL-germinal center B-cell (GCB)
mantle cell lymphoma (MCL)
GS-9820
phosphatidylinositol 3-kinase (PI3K)
Additional relevant MeSH terms:
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Neoplasms