---
title: Study of XL999 in Patients With Metastatic Colorectal Cancer
nct_id: NCT00277303
overall_status: TERMINATED
phase: PHASE2
sponsor: Symphony Evolution, Inc.
study_type: INTERVENTIONAL
primary_condition: Colorectal Cancer
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00277303.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00277303"
ct_last_update_post_date: 2010-02-22
last_seen_at: "2026-05-12T07:02:30.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study of XL999 in Patients With Metastatic Colorectal Cancer

**Official Title:** A Phase 2 Study of XL999 Administered Intravenously to Subjects With Metastatic Colorectal Cancer

**NCT ID:** [NCT00277303](https://clinicaltrials.gov/study/NCT00277303)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Study was terminated due to cardiac toxicities in the subjects
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 17
- **Lead Sponsor:** Symphony Evolution, Inc.
- **Conditions:** Colorectal Cancer
- **Start Date:** 2005-12
- **Completion Date:** 2007-02
- **CT.gov Last Update:** 2010-02-22

## Brief Summary

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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Interventions

- **XL999** (DRUG) — XL999 will be administered at 2.4 mg/kg as a 4-hour intravenous (IV) infusion. Subjects will receive XL999 infusions weekly for 8 weeks of treatment unless drug-related toxicity requires dosing delay. In the absence of progressive disease and unacceptable toxicity, subjects may receive XL999 treatment weekly for up to a year on this study. After 8 weeks, at the discretion of the investigator, one dose of four may be omitted for a subject's convenience.

## Primary Outcomes

- **Response rate** _(time frame: Inclusion until disease progression)_
- **Safety and tolerability** _(time frame: Inclusion until 30 days post last treatment)_

## Secondary Outcomes

- **Progression-free survival** _(time frame: Inclusion until disease progression)_
- **Duration of response** _(time frame: Inclusion until disease progression)_
- **Overall survival** _(time frame: Inclusion until last Follow-up post last treatment or death)_
- **Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters** _(time frame: Samples will be collected pre-dose and immediately at the end for subjects in the second stage of the study)_

## Locations (8)

- California Cancer Care, Inc., Greenbrae, California, United States
- Integrated Community Oncology Network; Division of Clinical Research, Jacksonville, Florida, United States
- Hematology Oncology Associated of the Treasure Coast, Port Saint Lucie, Florida, United States
- University of Chicago, Chicago, Illinois, United States
- Joliet Oncology-Hematology Associated, Ltd., Joliet, Illinois, United States
- Indiana University Cancer Center, Indianapolis, Indiana, United States
- Hematology Oncology Associates of Rockland, PC, New City, New York, United States
- Center for Oncology Research and Treatment, PA, Dallas, Texas, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.california cancer care, inc.|greenbrae|california|united states` — added _(2026-05-12)_
- `locations.integrated community oncology network; division of clinical research|jacksonville|florida|united states` — added _(2026-05-12)_
- `locations.hematology oncology associated of the treasure coast|port saint lucie|florida|united states` — added _(2026-05-12)_
- `locations.university of chicago|chicago|illinois|united states` — added _(2026-05-12)_
- `locations.joliet oncology-hematology associated, ltd.|joliet|illinois|united states` — added _(2026-05-12)_
- `locations.indiana university cancer center|indianapolis|indiana|united states` — added _(2026-05-12)_
- `locations.hematology oncology associates of rockland, pc|new city|new york|united states` — added _(2026-05-12)_
- `locations.center for oncology research and treatment, pa|dallas|texas|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00277303.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00277303*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*