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Follicular LymphomaPhase 1NCT02258555

Safety, Pharmacodynamics, Pharmacokinetics, and Efficacy of GS-9901 in Adults With Relapsed or Refractory Follicular Lymphoma, Marginal Zone Lymphoma, Chronic Lymphocytic Leukemia, or Small Lymphocytic Lymphoma

A Phase 1 study testing GS-9901 in people with Follicular Lymphoma and Chronic Lymphocytic Leukemia, run by Gilead Sciences at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will evaluate the safety and tolerability of GS-9901 monotherapy in adults with follicular lymphoma (FL), marginal zone lymphoma (MZL), chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
GS-9901
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
6 sitesUnited States
Study dates
Jan 2015to Aug 2015
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

  • Diagnosis of FL, MZL, SLL, or CLL (meeting International Workshop on CLL [IWCLL] Criteria, 2008) as documented by medical records and with histology based on criteria established by the World Health Organization
  • FL Grades 1, 2, or 3a
  • SLL with absolute lymphocyte count of < 5 x 10^9/L at initial diagnosis
  • MZL (splenic, nodal, or extra-nodal)
  • Prior treatment for FL or CLL/SLL with ≥ 1 prior chemotherapy-based or immunotherapy-based regimen with no approved therapies available
  • Presence of radiographically measurable lymphadenopathy or extra nodal lymphoid malignancy
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  • All acute toxic effects of any prior antitumor therapy resolved to Grade ≤1 before the start of study therapy (with the exception of alopecia [Grade 1 or 2 permitted], or bone marrow parameters [any of Grade 1, 2, or 3 permitted)
  • Eastern Cooperative Oncology Group (ECOG) ≤ 2
  • Able to provide written informed consent

Who cannot join

  • History of lymphoid malignancy other than FL, MZL, SLL, or CLL
  • History of myelodysplastic syndrome
  • History of a non-lymphoid malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for ≥ 1 year prior to start of study therapy, or any other cancer that has been in complete remission for ≥ 5 years
  • Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of start of study therapy
  • Ongoing drug-induced pneumonitis
  • Ongoing inflammatory bowel disease
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  • History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
  • History of prior therapy with any inhibitor of serine/threonine kinase (AKT), Bruton tyrosine kinase (BTK), Janus kinase (JAK), mammalian target of rapamycin (mTOR), phosphatidylinositol 3-kinase (PI3K), or spleen tyrosine kinase (SYK)
  • Ongoing immunosuppressive therapy, including systemic corticosteroids for treatment of lymphoid malignancy

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • City of Hope

    Duarte, California, 91010

  • Cancer Care Center of Fresno

    Fresno, California, 93720

  • Cancer Center Central Connecticut

    Southington, Connecticut, 06489

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

  • Lombardi Cancer Center-Georgetown University

    Washington D.C., District of Columbia, 02007

  • Innovative Clinical Research Institute

    Whittier, California, 90603

Other trials in United States

About this study

Official title: A Phase 1b Dose-escalation Study Evaluating the Safety, Pharmacodynamics, Pharmacokinetics, and Efficacy of GS-9901 in Subjects With Relapsed or Refractory Follicular Lymphoma, Marginal Zone Lymphoma, Chronic Lymphocytic Leukemia, or Small Lymphocytic Lymphoma

This study will evaluate the safety and tolerability of GS-9901 monotherapy in adults with follicular lymphoma (FL), marginal zone lymphoma (MZL), chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL). The study will also characterize the pharmacokinetic (PK) profile of GS-9901, determine the appropriate dosing regimen of GS-9901 for use in future clinical trials, and to evaluate the efficacy of GS-9901 monotherapy in adults with FL, MZL, CLL, or SLL.

Being tested
GS-9901
Keywords
Chronic lymphocytic leukemia (CLL), Follicular lymphoma (FL), Small Lymphocytic Lymphoma (SLL), Phosphatidylinositol 3 kinase (PI3K), Marginal Zone Lymphoma (MZL)
Medical subject headings
Lymphoma, Follicular, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell, Marginal Zone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GS-9901Drug

    GS-9901 tablets administered orally

Study groups in NCT02258555
Study groupRoleWhat they receive
GS-9901ExperimentalParticipants will receive one of 6 escalating doses of GS-9901 once daily until unacceptable toxicity, substantial noncompliance, disease progression, pregnancy, initiation of another anti-cancer or experimental therapy, or other protocol-specified reasons for GS-9901 discontinuation.
Receives: Drug: GS-9901

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of adverse events (AEs) and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs)

    Overall safety profile will be characterized by number of participants experiencing adverse events or laboratory abnormalities.

    Measured: Up to 28 days

Secondary outcomes (5)

  1. Occurrence of AEs and clinical laboratory abnormalities not defined as DLTs

    Overall safety profile will be characterized by number of participants experiencing adverse events or laboratory abnormalities.

    Measured: Up to 2 years

  2. Overall response rate

    Overall response rate (ORR) is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR).

    Measured: Up to 2 years

  3. Progression-free survival

    Progression-free survival (PFS) is defined as the interval from the start of study therapy to the earlier of the first documentation of definitive disease progression or death from any cause.

    Measured: Up to 2 years

  4. Duration of response

    Duration of response (DOR) is defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death from any cause.

    Measured: Up to 2 years

  5. PK profile of GS-9901

    This endpoint will measure the plasma PK profile of GS-9901. The following parameters will be measured:

    • Cmax: maximum observed concentration of drug in plasma
    • AUCtau: concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval)

    Measured: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, and 24 hours postdose on Days 1 and 15; predose and 1.5 hours postdose on Days 29, 43, 85, and 169

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

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
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02258555
Sponsor's protocol ID
GS-US-325-1348
Other IDs
2014-005441-53, 2014
Status last verified
Oct 2015
First submitted
3 Oct 2014
Last updated
19 Oct 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GS-9901 in people with Follicular Lymphoma and Chronic Lymphocytic Leukemia, run by Gilead Sciences at 6 sites in United States.

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 9 inclusion and 9 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: stopped early, as of the sponsor's last update on 19 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. 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 was stopped early. Results are not available in the source record.

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?

Occurrence of adverse events (AEs) and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs) (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02258555.

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 19 Oct 2015.

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