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Study of XL999 in Patients With Metastatic Colorectal Cancer

S

Symphony Evolution

Status and phase

Terminated
Phase 2

Conditions

Colorectal Cancer

Treatments

Drug: XL999

Study type

Interventional

Funder types

Industry

Identifiers

NCT00277303
XL999-206

Details and patient eligibility

About

This clinical study is being conducted at multiple sites to determine the activity, safety, and tolerability of XL999 when given weekly to patients with metastatic colorectal cancer (CRC). XL999 is a small molecule inhibitor of multiple kinases including VEGFR, PDGFR, FGFR, FLT-3, and Src, which are involved in tumor cell growth, formation of new blood vessels (angiogenesis), and metastasis.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Males and females with histologically confirmed metastatic colorectal cancer
  • Measurable disease according to Response Criteria for Solid Tumors (RECIST)
  • At least 1 prior therapeutic regimen (chemotherapy or biologic)
  • ECOG performance status of 0 or 1
  • Life expectancy ≥3 months
  • Adequate organ and marrow function
  • No other malignancies within 5 years
  • Signed informed consent

Exclusion criteria

  • Radiation to ≥25% of bone marrow within 30 days of XL999 treatment
  • Treatment with systemic anticancer therapy within 30 days of XL999 treatment
  • Subject has not recovered to ≤ grade 1 or to within 10% of baseline from adverse events due to other medications administered >30 days prior to study enrollment
  • History of or known brain metastases, current spinal cord compression, or carcinomatous meningitis
  • Uncontrolled and/or intercurrent illness
  • Pregnant or breastfeeding females
  • Known HIV

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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