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Dose Optimization Study of Idelalisib in Follicular Lymphoma

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ClinicalTrials.gov Identifier: NCT02536300
Recruitment Status : Recruiting
First Posted : August 31, 2015
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:
The primary objective of this study is to establish a safe and effective dosing regimen of idelalisib in participants with relapsed or refractory follicular lymphoma (FL) who have no other therapeutic options.

Condition or disease Intervention/treatment Phase
Follicular Lymphoma Drug: Idelalisib Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: As of protocol amendment 5, the Idelalisib 100 mg arm is closed to enrollment.
Masking: None (Open Label)
Masking Description: Double-blind: Prior to protocol amendment 5; Open-label: Participants enrolled as of protocol amendment 5
Primary Purpose: Treatment
Official Title: Dose Optimization Study of Idelalisib in Follicular Lymphoma
Actual Study Start Date : January 14, 2016
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : November 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Idelalisib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Idelalisib 150 mg Continuously

Participants will receive idelalisib 150 mg twice daily continuously.

For participants enrolled prior to protocol amendment 5: Based on the independent review committee (IRC) response assessment, participants may be discontinued from the study or may receive blinded or open-label idelalisib 150 mg twice daily.

 Drug: Idelalisib
Idelalisib tablet administered orally
Other Names:
  • Zydelig®
  • GS-1101
  • CAL-101
Experimental: Idelalisib 100 mg

Participants will receive idelalisib 100 mg twice daily continuously. Based on the IRC response assessment, participants may either be dose escalated to open-label 150 mg twice daily or maintain blind and continue on idelalisib 100 mg twice daily.

As of protocol amendment 5, enrollment to this arm has been closed.

 Drug: Idelalisib
Idelalisib tablet administered orally
Other Names:
  • Zydelig®
  • GS-1101
  • CAL-101
Experimental: Idelalisib 150 mg 28-Day Cycles
Participants will receive idelalisib 150 mg twice daily in 28-day cycles with 21 days on-treatment and 7 days off-treatment.
 Drug: Idelalisib
Idelalisib tablet administered orally
Other Names:
  • Zydelig®
  • GS-1101
  • CAL-101


Outcome Measures
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Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Up to end of radiographic assessment (approximately Week 84) ]
    ORR is defined as the proportion of participants who achieve a partial response (PR) or complete response (CR).

  2. Incidence of Grade ≥ 4 Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to end of study (approximately 10 years) ]

Secondary Outcome Measures :
  1. Duration of Response (DOR) [ Time Frame: Up to end of radiographic assessment (approximately Week 84) ]
    DOR is defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of disease progression by IRC or death from any cause.

  2. Overall Response Rate by Week 24 [ Time Frame: Up to Week 24 ]
    ORR by Week 24 is defined as the proportion of participants who achieve a PR or CR by Week 24.

  3. Overall Safety Profile of Idelalisib [ Time Frame: Up to end of study (approximately 10 years) ]
    The overall safety profile of idelalisib will include the incidence of adverse events (AE), clinically significant laboratory abnormalities, ≥ Grade 3 AEs, idelalisib-related AEs, serious adverse events (SAEs), and AEs leading to interruption, reduction, or discontinuation of idelalisib.

  4. Time to onset of adverse events of interest (AEI) [ Time Frame: Up to end of study (approximately 10 years) ]
    Time to onset of AEI is defined as the interval from the start of idelalisib treatment to the first documentation of start of AEI.

  5. Progression-Free Survival (PFS) [ Time Frame: Up to end of radiographic assessment (approximately Week 84) ]
    PFS is defined as the interval from randomization to the earlier of the first documentation of disease progression by IRC or death from any cause.

  6. Overall Survival (OS) [ Time Frame: Up to end of study (approximately 10 years) ]
    OS is defined as the interval from randomization to death from any cause.

  7. Idelalisib Trough (pre-dose) and Peak (1.5-hour samples) Plasma Concentrations [ Time Frame: Predose and 1.5 hours postdose in the morning up to Week 48 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Histologically confirmed diagnosis of B-cell follicular lymphoma (FL), and grade limited to 1, 2, or 3a based on criteria established by the WHO 2008 classification of tumors of hematopoietic and lymphoid tissues
  • Relapsed or refractory FL and have received at least 2 lines of prior therapy for FL and have no other therapeutic options
  • Ann-Arbor Stage 2 (non-contiguous), 3, or 4 disease per Lugano Classification Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures ≥ 1.5 cm in the longest dimension (LD) and ≥ 1.0 cm in the longest perpendicular dimension (LPD) as assessed by positron emission tomography-computed tomography (PET-CT), computed tomography (CT) or magnetic resonance imaging (MRI)
  • Required baseline central laboratory data in protocol.
  • For female individuals of childbearing potential and male individuals of reproductive potential, willingness to use a protocol- recommended method of contraception
  • Lactating females must agree to discontinue nursing
  • Willing and able to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions including mandatory prophylaxis for Pneumocystis jirovecii pneumonia (PJP)

Key Exclusion Criteria:

  • History of lymphoid malignancy other than FL (eg, diffuse large B-cell lymphoma)
  • Known history of, or clinically apparent, central nervous system (CNS) lymphoma or leptomeningeal lymphoma.
  • Known presence of intermediate- or high-grade myelodysplastic syndrome.
  • Known history of serious allergic reaction including anaphylaxis or Stevens- Johnson syndrome/ toxic epidermal necrolysis
  • History of a non-lymphoid malignancy except for protocol allowed exceptions
  • Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of enrollment
  • Known history of drug-induced liver injury, chronic active hepatitis B virus (HBV), chronic active hepatitis C virus (HCV), alcoholic liver disease, non-alcoholic steatohepatitis, cirrhosis of the liver, portal hypertension, primary biliary cirrhosis, or ongoing extrahepatic obstruction caused by cholelithiasis
  • History of or ongoing drug-induced pneumonitis
  • History of or ongoing inflammatory bowel disease
  • Known human immunodeficiency virus (HIV) infection
  • History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
  • Ongoing immunosuppressive therapy, including systemic corticosteroids (> 10 mg prednisone or equivalent/day) with the exception of the use of topical, enteric, or inhaled corticosteroids as therapy for comorbid conditions and systemic steroids for autoimmune anemia and/or thrombocytopenia
  • Concurrent participation in another therapeutic clinical trial
  • Prior treatment with phosphatidylinositol 3-kinase (PI3K) inhibitors
  • Cytomegalovirus (CMV)- Ongoing infection, treatment, or prophylaxis within 28 days prior to the Screening Visit CMV test

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536300


Contacts
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Contact: Gilead Clinical Study Information Center GileadClinicalTrials@gilead.com

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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
More Information
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02536300     History of Changes
Other Study ID Numbers: GS-US-313-1580
2015-000366-66 ( EudraCT Number )
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Lymphoma, Non-Hodgkin
Idelalisib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action