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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

Subjects with ABC-DLBCL, MCL, and SLL that fulfill the subject disease characteristics criteria as described for Cohorts B, C, or D.

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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

You have a type of lymphoma called ABC-DLBCL, MCL, or SLL that fits the specific criteria for this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4-6 months

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

ExelixisLead Sponsor

117 Previous Clinical Trials

19,549 Total Patients Enrolled

Frequently Asked Questions

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

What are the desired end-results of this experiment?

"This clinical trial aims to assess the objective response rate (ORR) of XL114 over a four-to-six month period. Secondary objectives include evaluating antitumor activity through progression free survival, overall survival duration, and tolerability as measured by dose intensity, modifications, and study discontinuation due to adverse effects."

Answered by AI

Has XL114 attained regulatory clearance from the FDA?

"Our experts at Power rate XL114's safety as a 1, due to the limited amount of evidence currently available from this Phase 1 trial."

Answered by AI

Does this experiment have any open positions for those seeking to participate?

"Clinicaltrials.gov confirms that this clinical trial, initially posted on April 12th 2022, is currently accepting enrolment applications. The study was last edited on September 1st of the same year."

Answered by AI

Can you provide an estimate of the aggregate amount of people participating in this clinical investigation?

"Exelixis, the trial's sponsor, must recruit 144 eligible participants located in multiple sites including Exelixis Clinical Site #2 in Spokane, Washington and Exelixis Clinical Site #1 in Indianapolis, Indiana."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of XL114 in Subjects With Non-Hodgkin's Lymphoma

2022. "Study of XL114 in Subjects With Non-Hodgkin's Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05144347.