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AZD0466 for Non-Hodgkin's Lymphoma
Phase 1 & 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 days 1, 4, 8, 9 and cycle 1 days 10, 11 only for part a; cycle 2 day 1, cycle 3 day 1, cycle 5 day 1 (cycle length 28 days)
Awards & highlights
Study Summary
This trial looks at the safety and effectiveness of a new drug, AZD0466, for treating patients with advanced non-Hodgkin lymphoma.
Eligible Conditions
- Non-Hodgkin's Lymphoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cycle 1 days 1, 4, 8, 9 and cycle 1 days 10, 11 only for part a; cycle 2 day 1, cycle 3 day 1, cycle 5 day 1 (cycle length 28 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 days 1, 4, 8, 9 and cycle 1 days 10, 11 only for part a; cycle 2 day 1, cycle 3 day 1, cycle 5 day 1 (cycle length 28 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part A: Incidence of adverse events (AEs) and dose-limiting toxicities (DLTs)
Part B: Objective Response Rate (ORR)
Secondary outcome measures
Part A and Part B (total AZD4320 only): Area under the plasma concentration-time curve from time 0 to 72 hours after the start of infusion (Dose normalised AUC0-72)
Part A and Part B (total AZD4320 only): Area under the plasma concentration-time curve from time 0 to time of last quantifiable analyte concentration divided by the dose administered (Dose normalised AUClast)
Part A and Part B (total AZD4320 only): Maximum observed plasma (peak) drug concentration divided by the dose administered (Dose normalised Cmax)
+15 moreTrial Design
8Treatment groups
Experimental Treatment
Group I: Part B (Dose Expansion): Cohort B3 (R/R DLBCL)Experimental Treatment1 Intervention
Participants with advanced R/R DLBCL will receive AZD0466 at the recommended phase 2 dose (RP2D) until maximum 2 years or until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study intervention, whichever occurs first.
Group II: Part B (Dose Expansion): Cohort B2 (R/R FL or MZL)Experimental Treatment1 Intervention
Participants with advanced R/R FL or MZL will receive AZD0466 at the recommended phase 2 dose (RP2D) until maximum 2 years or until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study intervention, whichever occurs first.
Group III: Part B (Dose Expansion): Cohort B1 (R/R MCL)Experimental Treatment1 Intervention
Participants with advanced R/R MCL will receive AZD0466 at the recommended phase 2 dose (RP2D) until maximum 2 years or until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study intervention, whichever occurs first.
Group IV: Part A (Dose Escalation): Dose Level (DL)-1Experimental Treatment1 Intervention
Participants with advanced R/R B-NHL will receive AZD0466 on day 1 , day 4, day 8 day 15, day 22 of cycle 1 and day 1, day 8 day 15, day 22 of cycle 2 and beyond until maximum 2 years or until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study intervention, whichever occurs first.
Group V: Part A (Dose Escalation): DL4Experimental Treatment1 Intervention
Participants with advanced R/R B-NHL will receive AZD0466 on day 1 , day 4, day 8 day 15, day 22 of cycle 1 and day 1, day 8 day 15, day 22 of cycle 2 and beyond until maximum 2 years or until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study intervention, whichever occurs first.
Group VI: Part A (Dose Escalation): DL3Experimental Treatment1 Intervention
Participants with advanced R/R B-NHL will receive AZD0466 on day 1 , day 4, day 8 day 15, day 22 of cycle 1 and day 1, day 8 day 15, day 22 of cycle 2 and beyond until maximum 2 years or until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study intervention, whichever occurs first.
Group VII: Part A (Dose Escalation): DL2Experimental Treatment1 Intervention
Participants with advanced R/R B-NHL will receive AZD0466 on day 1 , day 4, day 8 day 15, day 22 of cycle 1 and day 1, day 8 day 15, day 22 of cycle 2 and beyond until maximum 2 years or until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study intervention, whichever occurs first.
Group VIII: Part A (Dose Escalation): DL1Experimental Treatment1 Intervention
Participants with advanced R/R B-NHL will receive AZD0466 on day 1 , day 4, day 8 day 15, day 22 of cycle 1 and day 1, day 8 day 15, day 22 of cycle 2 and beyond until maximum 2 years or until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue study intervention, whichever occurs first.
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Who is running the clinical trial?
AstraZenecaLead Sponsor
4,259 Previous Clinical Trials
288,593,895 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You still have side effects from a previous cancer treatment that haven't gone away completely. If you have mild nerve damage (Grade 2 neuropathy) or hair loss (Grade 2 alopecia), you can still participate.You have a severe or uncontrolled disease that affects your entire body, such as respiratory or cardiac conditions, high blood pressure that cannot be managed, or a history of uncontrolled bleeding or infections.You must be 18 years or older to participate in the study. In some countries, if you are 18 years old, you may need your parents' permission to participate.You have been diagnosed with B-cell non-Hodgkin lymphoma, a type of cancer that affects white blood cells.This is a requirement that you must meet to be included in the study.You have tried 2 to 5 different treatments before but they did not work. There are no other treatment options available that can improve your survival.Your disease has come back after responding to previous treatment(s).You had a very serious type of cancer within the past two years before starting this study.
Research Study Groups:
This trial has the following groups:- Group 1: Part B (Dose Expansion): Cohort B1 (R/R MCL)
- Group 2: Part A (Dose Escalation): Dose Level (DL)-1
- Group 3: Part A (Dose Escalation): DL4
- Group 4: Part A (Dose Escalation): DL2
- Group 5: Part A (Dose Escalation): DL1
- Group 6: Part B (Dose Expansion): Cohort B3 (R/R DLBCL)
- Group 7: Part A (Dose Escalation): DL3
- Group 8: Part B (Dose Expansion): Cohort B2 (R/R FL or MZL)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What objectives are this experiment attempting to accomplish?
"According to AstraZeneca, the primary outcome for this trial will be Part B's Objective Response Rate (ORR), which is monitored from Screening until 28 days Post-treatment follow-up visit. Furthermore, secondary outcomes including Part A and Part B: Partial area under the plasma concentration-time curve from time 0 to 24 hours after infusion start (AUC0-24) Evaluation of AZD4320 PK profile with AZD0466, Part A and Part B: Area under the plasma concentration-curve from time 0 up until last quantifiable amount (AUClast) Assessment of AZD4320 in terms"
Answered by AI
Could I be considered a candidate for this medical study?
"This medical trial is recruiting 50 individuals who have been diagnosed with lymphoma, ranging from 18 to 130 years in age. Criteria for acceptance include: Upon signing the informed consent form, patients must be at least eighteen and may require parental permission depending on their country of origin; additionally, they must have a confirmed B-cell non-Hodgkin's lymphoma diagnosis based on World Health Organisation guidelines (with exceptions)."
Answered by AI
Are there still available openings to participate in this trial?
"Affirmative, the clinical trial is actively recruiting according to information available on clinicialtrials.gov. The study was first posted on July 5th 2022 and has been revised as of October 3rd 2022. This research requires 50 participants across 6 sites to be enrolled."
Answered by AI
Are any octogenarians participating in this trial?
"The patient selection process for this research initiative requires that participants are at least 18 years of age and not older than 130."
Answered by AI
What is the total capacity of individuals participating in this experiment?
"Affirmative. According to clinicaltrials.gov, the trial commenced on 5th July 2022 and was most recently updated on 3rd October 2022 - it is actively recruiting 50 participants from 6 medical establishments."
Answered by AI
What is the prevalence of hospitals conducting this experiment across the state?
"There are 6 locations in total recruiting patients for this trial, with sites located in Baltimore, Rochester and Duarte amongst others. It is suggested that participants select the nearest medical centre to reduce travel requirements."
Answered by AI
Who else is applying?
What state do they live in?
California
District of Columbia
Pennsylvania
Other
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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