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Study of CRLX101 (NLG207) in the Treatment of Advanced Solid Tumors

NCT00333502 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2020-05-28

No results posted yet for this study

Summary

CRLX101 is a nanopharmaceutical comprised of the chemotherapeutic camptothecin (CPT) conjugated to a linear, cyclodextrin-based polymer. CRLX101 is designed to increase the exposure of tumor cells to CPT while minimizing side effects.

OBJECTIVES:

• Determine the safety, toxicity, and the maximum tolerated dose (MTD) of CRLX101 when administered intravenously to subjects with advanced solid tumors.

Conditions

Interventions

DRUG

Camptothecin (CPT) conjugated to a linear, cyclodextrin-based polymer

Subjects who meet inclusion/exclusion criteria will receive CRLX101 every other week.

Sponsors & Collaborators

  • NewLink Genetics Corporation

    lead INDUSTRY

Principal Investigators

  • Yun Yen, M.D., Ph.D. · City of Hope National Medical Center

  • Glenn Weiss, M.D. · Virginia G. Piper Cancer Center

  • Jeffrey D. Neidhart, M.D. · San Juan Oncology Associates

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2011-11-30
Completion
2012-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00333502 on ClinicalTrials.gov