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PI3K Inhibitor

Paxalisib for Central Nervous System Lymphoma

Phase 2
Recruiting
Research Sponsored by Lakshmi Nayak
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants should have evidence of refractory or recurrent disease on MRI with measurable or evaluable enhancing disease
Participants must be at least 18 years old on day of signing informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial is testing a drug to see if it can treat a type of cancer called primary central nervous system lymphoma.

Who is the study for?
Adults with confirmed recurrent or refractory primary DLBCL CNS lymphoma, who have measurable disease on MRI and are stable after previous treatments, can join. They must be able to undergo MRI scans, have good organ function, use effective contraception if applicable, and not require high doses of steroids. Excluded are those with other active cancers or infections like HIV/Hepatitis B/C, allergy to Paxalisib components, uncontrolled illnesses or hypertension.Check my eligibility
What is being tested?
The trial is testing the effectiveness of a drug called Paxalisib (GDC-0084) for treating primary central nervous system lymphoma that has come back or hasn't responded to treatment. Participants will receive this oral medication under study conditions to see how well it works against their cancer.See study design
What are the potential side effects?
Paxalisib may cause side effects such as difficulty swallowing pills due to gastrointestinal issues; potential allergic reactions; possible interactions with strong CYP3A4 inhibitors/inducers affecting drug metabolism; and risks in patients with diabetes mellitus.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My MRI shows my disease is not responding to treatment and can be measured.
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I am at least 18 years old.
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I am mostly able to care for myself.
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My lymphoma in the brain has been confirmed by a biopsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with Objective Response Rate (ORR)
Secondary outcome measures
Number of cumulative treatment-emergent adverse events (TEAEs)
Number of participants with Durable Objective Response Rate (ORR)
Overall Survival
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: PAXALISIBExperimental Treatment1 Intervention
The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits. Paxalisib (GDC-0084) Each study treatment cycle lasts 28 days, up to 24 months.

Find a Location

Who is running the clinical trial?

Lakshmi NayakLead Sponsor
Lakshmi Nayak, MDLead Sponsor
Kazia Therapeutics LimitedIndustry Sponsor
11 Previous Clinical Trials
1,565 Total Patients Enrolled

Media Library

Paxalisib (PI3K Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04906096 — Phase 2
Central Nervous System Lymphoma Research Study Groups: PAXALISIB
Central Nervous System Lymphoma Clinical Trial 2023: Paxalisib Highlights & Side Effects. Trial Name: NCT04906096 — Phase 2
Paxalisib (PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04906096 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you speak to the safety of PAXALISIB for human consumption?

"We assign PAXALISIB a safety rating of 2 on our scale, as Phase II trials have yielded data that indicate its security but not yet the drug's efficacy."

Answered by AI

How many participants is this clinical trial accommodating?

"Affirmative. Clinicaltrials.gov reveals that this clinical trial, launched on June 1st 2021, is accepting applications from volunteers. 25 participants will be accepted in total between the 2 sites involved in the study."

Answered by AI

Does this experiment represent a pioneering effort within its field?

"As of now, 6 trials using PAXALISIB are still running in 51 urban centres and 7 countries. This molecule was initially tested by Kazia Therapeutics Limited back in 2018, with 27 participants participating in the Phase 1 trial. Since then, one study has been finished successfully."

Answered by AI

Have any other experiments been conducted utilizing PAXALISIB as a treatment?

"Currently, 6 clinical trials are underway researching the effectiveness of PAXALISIB. One study is in its final phase while the rest are distributed across 77 sites with a majority located in Boston, Massachusetts."

Answered by AI

Are there opportunities for volunteers to participate in this research?

"Confirmed; this clinical trial, first launched on the 1st of June 2021 is currently recruiting. Its details were most recently amended on 11th July 2022."

Answered by AI
~1 spots leftby May 2024