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MSX-122 Administered Orally in Patients With Refractory Metastatic or Locally Advanced Solid Tumors

NCT00591682 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2008-03-26

No results posted yet for this study

Summary

Primary Objectives:

1. To determine the maximum tolerated dose (MTD) and the recommended Phase II dose(s) and schedule of MSX-122
2. To characterize the dose limiting toxicities (DLTs) and determine the overall safety and tolerability of MSX-122

Secondary Objectives:

1. To determine the pharmacokinetics and pharmacodynamics of orally administered MSX-122
2. To evaluate the preliminary evidence for anti-tumor activity of MSX-122
3. To perform correlative studies to elucidate signaling pathways involved in CXCR4 activation in blood and optional tissue specimens by IHC (immunohistochemistry) and RPPA (reverse phase protein microarrays)

Conditions

Interventions

DRUG

MSX-122

Dosage form = capsule Starting Dose (First Patient Cohort - Dose Level 1) = 50 mg taken orally once daily, 7 days per week for 4 weeks (total of 28 days), followed immediately by a second course of 28 days with identical dosage form and schedule. (Each patient in each cohort treated for a minimum of 56 days, unless obviated by toxicity.) * If there is no evidence of toxicity at the current dose level, then the dose of MSX-122 will be increased by 100% for the next patient cohort. * If a grade 1-2 toxicity is observed, then the dose will be increased by 50% for the next patient cohort. * If a grade 3 toxicity (non-dose limiting toxicity) is observed then the dose will be increased by 25% for the next patient cohort.

Sponsors & Collaborators

  • Metastatix, Inc.

    lead INDUSTRY

Principal Investigators

  • Jennifer J. Wheler, MD · M.D. Anderson Cancer Center

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
2007-11-30
Primary Completion
2008-12-31
Completion
2009-03-31

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 NCT00591682 on ClinicalTrials.gov