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Alkylating agents

XL114 for Non-Hodgkin's Lymphoma

Phase 1
Waitlist Available
Research Sponsored by Exelixis
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 4-6 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug, XL114, to see if it is safe and effective. The study will also help determine the best dose of the drug.

Eligible Conditions
  • Non-Hodgkin's Lymphoma
  • Mantle Cell Lymphoma
  • Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Chronic Lymphocytic Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-6 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
Cohort-Expansion Stage: Objective Response Rate (ORR)
Dose-Escalation Stage: Recommended Dose (RD) and/or Maximum Tolerated Dose (MTD) for XL114
Secondary outcome measures
Cohort-Expansion Stage: Antitumor Activity of XL114 (Duration of Response [DOR])
Cohort-Expansion Stage: Antitumor Activity of XL114 (Objective Response Rate [ORR])
Cohort-Expansion Stage: Antitumor Activity of XL114 (Progression Free Survival [PFS])
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: XL114 Expansion CohortsExperimental Treatment1 Intervention
The recommended dose from the Dose-Escalation stage, will be used in subjects with activated B-cell-like diffuse large B-cell lymphoma [ABC-DLBCL] (Cohort B), mantle cell lymphoma [MCL] (Cohort C), chronic lymphocytic leukemia [CLL]/small lymphocytic lymphoma [SLL] (Cohort D). Subjects will also be enrolled in a Biomarker cohort (Cohort E).
Group II: XL114 Dose-Escalation CohortsExperimental Treatment1 Intervention
Subjects (Cohort A1-An) will accrue in cohorts of 3-12 subjects in a i3+3 design.

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Who is running the clinical trial?

ExelixisLead Sponsor
117 Previous Clinical Trials
19,532 Total Patients Enrolled
~1 spots leftby Jun 2025
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