To provide idelalisib, a marketed PI3K* inhibitor, in lieu of GS-9820, an investigational second generation PI3K* inhibitor, to subjects receiving GS-9820 in Study GS-US-315-0102 at the time of study closure.
ID
Source
Brief title
Condition
- Other condition
- Leukaemias
Synonym
Health condition
CLL
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
There are no primary endpoints of this study.
Secondary outcome
There are no secondary endpoints of this study
Background summary
B-cell lymphoid malignancies comprise the most common hematological
malignancies. These cancers arise from the accumulation of monoclonal B
lymphocytes in lymph nodes and often in organs such as blood, bone marrow,
lymph nodes, spleen, and liver. Among the variants of these cancers are
non-Hodgkin lymphomas (NHL) * including diffuse large B-cell lymphoma (DLBCL),
indolent non-Hodgkin lymphoma (iNHL), and mantle cell lymphoma (MCL) * chronic
lymphocytic leukemia (CLL), and Hodgkin lymphoma (HL). The goal of therapy for
these diseases is to induce tumor regression and delay tumor progression in
order to control disease-related complications and potentially extend life.
Patients who require treatment are commonly given chemotherapeutic and/or
immunotherapeutic agents. For any of these cancers, further sequential
therapies are given in an attempt to control disease manifestations. Despite
use of agents with differing mechanisms of action, progressive resistance to
treatment develops. Patients with progressive disease have a poor prognosis;
median survival for these groups of patients is generally *2 years. Novel
mechanisms of action are needed to offer additional treatment options for
patients with lymphoid malignancies who are experiencing progressive
lymphadenopathy or symptoms due to disease progression. Knowledge of the
critical importance of PI3K* in B-cell biology and neoplasia has encouraged a
search for inhibitors of this enzyme that could provide new options in the
therapy of lymphoid malignancies, including CLL. Gilead Sciences, Inc has
developed novel drugs that can suppress tumor growth through targeting of PI3K
activity. High-throughput screening was the basis for the discovery of novel
agents that selectively inhibit PI3K isoform function. These efforts initially
led to identification of GS-1101 (also known as CAL-101), a 415-Dalton, orally
bio-available, investigational drug that represented a first-in-class selective
inhibitor of PI3K*.
This rollover study provides access to idelalisib for eligible subjects
receiving GS-9820 in Study
GS-US-315-0102 at the time of study closure.
Study objective
To provide idelalisib, a marketed PI3K* inhibitor, in lieu of GS-9820, an
investigational second generation PI3K* inhibitor, to subjects receiving
GS-9820 in Study GS-US-315-0102 at the time of study closure.
Study design
This study is an open-label, rollover study to provide idelalisib to subjects
receiving GS-9820 in Study GS-US-315-0102 at the time of study closure.
Intervention
Idelalisib will be administered on a BID schedule starting on Day 1. Treatment
will persist until the earliest of subject withdrawal from study, disease
progression, intolerable Idelalisib-related toxicity, pregnancy, substantial
noncompliance with study procedures, or study discontinuation
Study burden and risks
The patient is subjected to investigations that would take place in their
regular care. However they will be tested for possible infections and will be
required to start profylaxis treatment for PJP. Patients will be required to
visit the outpatient clinic biweekly for 24 weeks, then monthly. Prior to each
visit to the outpatient clinic, a blood sample will be taken to check the blood
values. With regular care the patient would come monthly for follow up and will
get their blood levels checked. The following side effects have been reported
and might have been caused by Idela: infections and death, Severe diarrhea or
colitis, Liver injury, Rash, Decrease in a certain type of white blood cell,
Fever, Inflammation of the lungs, Severe blistering rash, Toxic epidermal
necrolysis. For these patients there are no curative options. There are no
standard treatments for these people available. The expectation is that the
drug under study is effective with acceptable toxicity.
Lakeside Drive 333
Foster City CA 94404
US
Lakeside Drive 333
Foster City CA 94404
US
Listed location countries
Age
Inclusion criteria
1) Receiving GS-9820 in Study GS-US-315-0102 with objective evidence of clinical benefit defined as at least stable disease on imaging assessed by the IRC at the time of Study GS-US-315-0102 closure;2) For female subjects of childbearing potential, willingness to use a protocol recommended method of contraception during heterosexual intercourse from the signing of informed consent throughout the study treatment period and up to 30 days from the last dose of idelalisib;3) For male subjects of reproductive potential having intercourse with females of childbearing potential, willing to use a protocol recommended method of contraception during heterosexual intercourse and to refrain from sperm donation throughout the study treatment period and for 90 days following discontinuation of idelalisib;4) Willingness to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions, including mandatory prophylaxis for Pneumocystis jirovecci pneumonia (PJP). Note: Psychological, social, familial, or geographical factors that might preclude adequate study participation should be considered.;5) Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of their disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, possible side effects, potential risks and discomforts, and other pertinent aspects of study participation.
Exclusion criteria
1) Known hypersensitivity or intolerance to any of the active substances or excipients in the formulation of idelalisib.;2) Toxicities that would preclude initiating therapy with idelalisib prior to enrolment (eg history of drug-induced pneumonitis, ongoing inflammatory bowel disease);3) Concurrent participation in another therapeutic clinical trial.;4) Pregnant or breastfeeding.;5) Ongoing infection, treatment, or profylaxis for CMV within the past 28 days.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-005766-39-NL |
| CCMO | NL56615.018.16 |