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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
No Placebo-Only Group
Summary
This trial tests a new drug called AZD0466 for patients with advanced non-Hodgkin lymphoma who haven't responded to other treatments. The study will check if the drug is safe, how well patients can handle it, and if it can stop cancer growth.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part A: Incidence of adverse events (AEs) and dose-limiting toxicities (DLTs)
Part B: Objective Response Rate (ORR)
Secondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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
4,397 Previous Clinical Trials
289,121,649 Total Patients Enrolled
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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 A (Dose Escalation): Dose Level (DL)-1
- Group 2: Part A (Dose Escalation): DL2
- Group 3: Part A (Dose Escalation): DL4
- Group 4: Part B (Dose Expansion): Cohort B1 (R/R MCL)
- 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.
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