Study of XL999 in Adults With Solid Tumors

Cancer Clinical Trial

Official title:

A Phase 1 Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL999 Administered Intravenously to Subjects With Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00104117
• Other study ID #: XL999-001
• Status: Completed
• Phase: Phase 1
• First received: February 23, 2005
• Last updated: February 18, 2010
• Start date: November 2004
• Est. completion date: October 2008

Study information

• Verified date: February 2010
• Source: Symphony Evolution, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and tolerability of XL999 in adults with advanced solid tumors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Advanced solid tumor

• Cancer that has progressed on currently available therapies

• Life expectancy of >3 months

• Adequate bone marrow, liver, and kidney function

• Willing to use accepted method of contraception during the course of the study

• Negative pregnancy test (females)

• Written informed consent

Exclusion Criteria:

• Chemotherapy within 4-6 weeks of the start of treatment (depending on the therapy)

• Radiotherapy within 4 weeks of the start of treatment

• Subjects with known brain metastasis

• Uncontrolled medical disorder such as infection or cardiovascular disease

• Subjects known to be HIV positive

• Pregnant or breastfeeding women

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• XL999
XL999 was to be given biweekly to an initial cohort of subjects at 0.20 mg/kg and to successive cohorts at doses that escalated by cohort according to a design for safely determining an MTD. After determination of the MTD, one or more additional cohorts were to receive XL999 weekly at the MTD or a lower dose, as determined by the CRC on the basis of interim safety and PK data. By a protocol amendment after initiation of the study, subjects were to be enrolled in an additional cohort to receive a weekly XL999 dose of 200 mg.

Locations

Country	Name	City	State
United States	Case Western Reserve University, Univserzity Hospitals of Cleveland	Cleveland	Ohio
United States	Cancer Therapy and Research Center, Institute for Drug Development	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Symphony Evolution, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the maximum tolerated dose (MTD) and to assess the safety and tolerability of XL999 administered as a single 4-hour intravenous (IV) infusion in subjects with solid tumors		Inclusion until 30 days post last treatment	Yes
Secondary	To evaluate plasma pharmacokinetics (PK) and estimate renal elimination of XL999 administered as a single 4-hour IV infusion in subjects with solid tumors		Various timepoints from pre-dosing until 48 hours post dose.	Yes
Secondary	To evaluate the PK of XL999 administered at a fixed weekly dose of 200 mg.		At various timepoints from pre-dosing until 48 hours post dosing	Yes