Clinical trial NCT00879684: Safety And PK Study Of CVX-060 In Patients With Advanced Solid Tumors
Official title: A Phase 1, Multicenter, Open-label, Dose-escalation, Safety, Pharmacokinetic, And Pharmacodynamic Trial Of Cvx-060, A Selective Angiopoietin-2 (Ang-2) Binding, Anti-angiogenic Covx-body, In Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Neoplasms
Carcinoma
Cancer
Malignancy
Keywords: Phase 1
Tumors
CVX-060
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-04-10
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and tolerability of CVX-060 in patients with advanced solid tumors.


Eligibility criteria: 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 evaluations.
* ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.

Exclusion Criteria:

* Evidence of significant bleeding problems.
* History of certain gastrointestinal problems including fistula and abscess.
* Chronic, uncontrolled hypertension.
* Patients with any history of primary or metastatic tumor involvement of the brain or with tumors that encase great vessels.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
timeFrame: Baseline (Day 0) up to 30 days after last dose of study medication
Secondary outcomes:
measure: Maximum Observed Serum Concentration (Cmax)
timeFrame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
measure: Serum Decay Half-Life (t1/2)
timeFrame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
measure: Area Under the Curve From Time Zero to 168 Hours [AUC (0-168)]
timeFrame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
measure: Apparent Volume of Distribution (Vss)
timeFrame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
measure: Apparent Clearance (CL)
timeFrame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
measure: Time to Reach Maximum Observed Serum Concentration (Tmax)
timeFrame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle)
measure: Recommended Phase 2 Dose (RP2D): Stage 1
timeFrame: Baseline (Day 0) up to 42 days after the last dose of study medication
measure: Number of Participants With Anti-CVX-060 Antibodies
timeFrame: Baseline (Day 0) up to 42 days after last dose
measure: Number of Samples From Participants With Anti-CVX-060 Antibodies
timeFrame: Baseline (Day 0) up to 42 days after last dose
measure: Number of Participants With Best Overall Response (BOR)
timeFrame: Day 0 (predose), assessed every 8 weeks (2 cycles) until disease progression, unacceptable toxicity, or withdrawal for other reasons (up to Week 133)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Medical Imaging, Ltd.
state: Arizona
city: Scottsdale
country: United States
facility: Premiere Oncology of Arizona
state: Arizona
city: Santa Monica,
country: United States
facility: Premiere Oncology, A Medical Corporation
state: California
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: