A Phase 1b Study Evaluating GS-9820 in Subjects With Lymphoid Malignancies

Lymphoid Malignancies Clinical Trial

Official title:

A Phase 1b Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GS-9820 in Subjects With Lymphoid Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01705847
• Other study ID #: GS-US-315-0102
• Secondary ID: 2012-000360-19
• Status: Completed
• Phase: Phase 1
• First received: October 8, 2012
• Last updated: May 16, 2016
• Start date: November 2012
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoid Malignancies
• Neoplasms

Intervention

Drug:
• GS-9820
GS-9820 tablets containing 200 mg of GS-9820 administered orally

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam
Netherlands	VU Medical Center (VUmc)	Amsterdam
Netherlands	St. Antonius Hospital	Nieuwegein
Netherlands	Erasmus MC - Daniel den Hoed Cancer Center	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD)	MTD will be assessed to determine the appropriate dosing regimens for use in future clinical trials of GS-9820 in subjects with lymphoid malignancies.	Up to 4 weeks	No
Secondary	Overall safety	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.	Up to 5 years	No
Secondary	Pharmacokinetic parameters of GS-9820 as measured by Cmax, Tmax, Ctrough, and AUC	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	Baseline to Day 29	No
Secondary	Pharmacodynamics to measure changes in the phosphatidylinositol 3-kinase (P13K) delta pathway activation and changes in plasma concentration of disease-associated chemokines and cytokines		Baseline to Day 29	No
Secondary	Tumor control	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.	Up to 5 years	No
Secondary	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)		Up to 5 years	No
Secondary	Drug exposure	Drug administration for GS-9820 as assessed by prescribing records and GS-9820 compliance as assessed by quantification of used and unused drug.	Up to 5 years	No