NCT01705847

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2012

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 12, 2012

Completed
20 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

3.5 years

First QC Date

October 8, 2012

Last Update Submit

May 16, 2016

Conditions

Lymphoid Malignancies

Keywords

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-9820phosphatidylinositol 3-kinase (PI3K)

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Overall safety

    Up to 5 years

  • Pharmacokinetic parameters of GS-9820 as measured by Cmax, Tmax, Ctrough, and AUC

    Baseline to Day 29

  • 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

  • Tumor control

    Up to 5 years

  • 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

  • +1 more secondary outcomes

Study Arms (1)

GS-9820

EXPERIMENTAL

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

Interventions

GS-9820DRUG

GS-9820 tablets containing 200 mg of GS-9820 administered orally

Also known as: CAL-120
GS-9820

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

VU Medical Center (VUmc)

Amsterdam, 1081 HV, Netherlands

Location

Academic Medical Center

Amsterdam, 1105 AZ, Netherlands

Location

St. Antonius Hospital

Nieuwegein, 3435 CM, Netherlands

Location

Erasmus MC - Daniel den Hoed Cancer Center

Rotterdam, 3075 EA, Netherlands

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLymphoma, Non-HodgkinHodgkin DiseaseLymphoma, Mantle-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma

Study Officials

  • Henry Adewoye, MD

    Gilead Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2012

First Posted

October 12, 2012

Study Start

November 1, 2012

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations

NL(4)