A Safety And Pharmacokinetic Study With CVX-045 In Patients With Advanced Solid Tumors

A Multicenter, Open-Label, 2-Stage, Phase 1, Clinical Safety, Pharmacokinetic, And Pharmacodynamic Study Of CVX-045, A Thrombospondin-1 Mimetic, Anti-Angiogenic Agent, In Patients With Advanced Solid Tumors

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00879554

Acronym

CVX-045-101

Enrollment

Registered

2009-04-10

Start date

2007-02-28

Completion date

2010-11-30

Last updated

2010-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors, Cancer, Carcinoma, Malignancy, Neoplasms

Keywords

Phase 1, Solid Tumors, CVX-045

Brief summary

The purpose of the study is to determine safety and tolerability of CVX-045 in patients with advanced solid tumors.

Interventions

BIOLOGICALCVX-045

Weekly, intravenous dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Confirmed advanced solid tumors unresponsive to currently available therapies, or for which there is no standard therapy. * Adequate coagulation, liver and renal function. * Candidate for DCE-MRI evaluation. * ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.

Exclusion criteria

* Evidence of bleeding problems. * Uncontrolled hypertension. * Certain gastrointestinal problems including fistula and abscess. * Patients with primary brain cancer.

Design outcomes

Primary

Measure	Time frame
To determine safety and tolerability of CVX-045 as weekly intravenous (IV) infusions in adult patients with advanced solid tumors	Throughout duration of study
To identify and characterize CVX-045-related adverse events (AEs)	Throughout duration of study

Secondary

Measure	Time frame
To evaluate the plasma pharmacokinetics (PK) of CVX-045	Days 1, 4, 8, 15, 29
To determine a recommended Phase 2 dose of CVX-045	End of study
To evaluate the potential for immunogenicity of CVX-045	Days 1, 15, 1st day of every subsequent cycle, EOS, 30 Day FU
To document any preliminary evidence of antitumor activity	Every 8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026