Lymphoid MalignanciesPhase 1NCT01705847
A Phase 1b Study Evaluating GS-9820 in Subjects With Lymphoid Malignancies
A Phase 1 study testing GS-9820 in people with Lymphoid Malignancies, run by Gilead Sciences at 4 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoid Malignancies
- What is being tested?
- GS-9820
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 4 sitesNetherlands
- Study dates
- Nov 2012to May 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously treated recurrent B-cell iNHL, DLBCL, MCL, HL or CLL
- Measurable lymphadenopathy
- Requires therapy
Who cannot join
- Recent history of a major non-lymphoid malignancy
- Evidence of ongoing infection
- Concurrent participation in another therapeutic clinical trial
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
VU Medical Center (VUmc)
Amsterdam, 1081 HV
Academic Medical Center
Amsterdam, 1105 AZ
St. Antonius Hospital
Nieuwegein, 3435 CM
Erasmus MC - Daniel den Hoed Cancer Center
Rotterdam, 3075 EA
About this study
Official title: A Phase 1b Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GS-9820 in Subjects With Lymphoid Malignancies
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.
- Conditions
- Lymphoid Malignancies
- Being tested
- GS-9820
- 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-9820, phosphatidylinositol 3-kinase (PI3K)
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin, Hodgkin Disease, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-9820Drug
Also called CAL-120
GS-9820 tablets containing 200 mg of GS-9820 administered orally
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: GS-9820 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 weeks
Secondary outcomes (6)
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.
Measured: Up to 5 years
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
Measured: 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
Measured: Baseline to Day 29
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.
Measured: 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)
Measured: Up to 5 years
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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoid MalignanciesStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henry Adewoye, MD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705847
- Sponsor's protocol ID
- GS-US-315-0102
- Other IDs
- 2012-000360-19
- Status last verified
- May 2016
- First submitted
- 8 Oct 2012
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GS-9820 in Subjects With Lymphoid Malignancies
- ClinicalTrials.gov ID
- NCT01705847
- Acronym / sponsor ID
- GS-US-315-0102
- 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-9820
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 12 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GS-9820 | Experimental | Drug: GS-9820Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Previously treated recurrent B-cell iNHL, DLBCL, MCL, HL or CLL
- Measurable lymphadenopathy
- Requires therapy
Key exclusion criteria (3 listed)
- Recent history of a major non-lymphoid malignancy
- Evidence of ongoing infection
- Concurrent participation in another therapeutic clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GS-9820Also: CAL-120GS-9820 tablets containing 200 mg of GS-9820 administered orally | Drug | GS-9820 |
Primary outcome
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.
6 secondary outcomes
Overall safety
Time frame: Up to 5 years
Pharmacokinetic parameters of GS-9820 as measured by Cmax, Tmax, Ctrough, and AUC
Time frame: 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
Time frame: Baseline to Day 29
Tumor control
Time frame: 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)
Time frame: Up to 5 years
Drug exposure
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Adewoye, MD study director
Gilead Sciences
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GS-9820 in people with Lymphoid Malignancies, run by Gilead Sciences at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2016.