Lymphoid Malignancies MedDRA version: 19.0 Level: LLT Classification code 10066481 Term: Hematological malignancy System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Zydelig
Product Name: Idelalisib
Product Code: GS-1101
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IDELALISIB
CAS Number: 870281-82-6
Current Sponsor code: GS-1101
Concent
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
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 prophylaxis for CMV within the past 28 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to provide idelalisib to subjects receiving GS-9820 in Study GS-US-315-0102 at the time of study closure.;Secondary Objective: Not applicable;Primary end point(s): There is no primary endpoint of this study.;Timepoint(s) of evaluation of this end point: Not applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): There is no secondary endpoint of this study.;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Netherlands
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd.
Outcome results
None listed