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Paxalisib (GDC-0084) In Recurrent Or Refractory PCNSL

ConditionsPrimary Central Nervous System LymphomaNon-Hodgkin Lymphoma of Extranodal Site
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLakshmi Nayak, MD

About this trial

This research study is studying a drug called Paxalisib (GDC-0084) as a possible treatment for primary central nervous system lymphoma (PCNSL)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must be able to understand and willing to sign a written informed consent document.

Participant must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.

Participant must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.

Participants must be at least 18 years old on day of signing informed consent.

Disqualifiers

Participants unable to undergo MRI brain.

Participants with active systemic disease.

Participants with uncontrolled intercurrent illness.

Participants with prior exposure to mTOR/PI3K inhibitors

Trial design

Design model

Single group

Treatments tested in this trial

  • PAXALISIB

    Drug

    Each study treatment cycle lasts 28 days, up to 24 months. Oral, daily, dosage per protocol

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: PAXALISIBExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with Objective Response Rate (ORR)

The Objective Response (ORR) is defined as a complete, unconfirmed complete or partial response as determined by the investigator assessment using IPCG criteria

Time frame
Up to 24 Months

Secondary outcomes

1

Number of participants with Durable Objective Response Rate (ORR)

Durable ORR will be defined as confirmed objective responses (CR, uCR and PR) by IPCG criteria that are durable for ≥ 6 months

Time frame
Up to 24 Months
2

Overall Survival

defined from the date of the 1st dose of paxalisib to the date of death or last follow-up. If a participant is still alive, she/he will be censored on the date of last followup.

Time frame
Up to 24 Months
3

Progression Free Survival (PFS)

defined from the date of 1st dose of paxalisib to the date of progression based on IPCG criteria or death, if progression does not occur. All progressors will be included regardless of whether progression occurs while the participant was taking the study drug or previously discontinued the study drug

Time frame
up to 24 Months
4

Number of cumulative treatment-emergent adverse events (TEAEs)

Incidence of TEAEs, grade 3-5 TEAEs, SAEs (serious adverse events) and TEAEs leading to discontinuation of study treatment.

Time frame
up to 24 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lakshmi Nayak, MD

Lead sponsor

Dana-Farber Cancer Institute

Sponsor institution

Kazia Therapeutics Limited

Collaborator

Source ClinicalTrials.gov
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