Safety And PK Study Of CVX-060 In Patients With Advanced Solid Tumors
|ClinicalTrials.gov Identifier: NCT00879684|
Recruitment Status : Completed
First Posted : April 10, 2009
Results First Posted : January 26, 2015
Last Update Posted : January 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors Neoplasms Carcinoma Cancer Malignancy||Biological: CVX-060||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||January 2008|
|Primary Completion Date :||April 2011|
|Study Completion Date :||April 2011|
Weekly, intravenous dose
- Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) [ Time Frame: Baseline (Day 0) up to 30 days after last dose of study medication ]Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to CVX-060 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
- Maximum Observed Serum Concentration (Cmax) [ Time Frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) ]
- Serum Decay Half-Life (t1/2) [ Time Frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) ]Serum decay half-life is the time measured for the serum concentration to decrease by one half.
- Area Under the Curve From Time Zero to 168 Hours [AUC (0-168)] [ Time Frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) ]AUC (0-168)= Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours after dosing (Day 7).
- Apparent Volume of Distribution (Vss) [ Time Frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) ]Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after intravenous infusion dose (Vss) is influenced by the fraction absorbed.
- Apparent Clearance (CL) [ Time Frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) ]Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed.
- Time to Reach Maximum Observed Serum Concentration (Tmax) [ Time Frame: 0 hour (pre-dose) on Day 0 up to Day 7 of cycle 1 (28 days cycle) ]
- Recommended Phase 2 Dose (RP2D): Stage 1 [ Time Frame: Baseline (Day 0) up to 42 days after the last dose of study medication ]RP2D was determined as the highest dose where none out of 3 (0/3) or less than or equal to 1 out of 6 (<=1/6) participants experienced a dose limiting toxicity (DLT) or was determined based on the safety, pharmacokinetic, and pharmacodynamic findings. DLT was first course AE defined based on National Cancer Institute common toxicity criteria for adverse events version 3 (NCI-CTCAE Version 3) as any hematologic or non-hematologic toxicity greater than or equal to (>=) Grade 3.
- Number of Participants With Anti-CVX-060 Antibodies [ Time Frame: Baseline (Day 0) up to 42 days after last dose ]
- Number of Samples From Participants With Anti-CVX-060 Antibodies [ Time Frame: Baseline (Day 0) up to 42 days after last dose ]
- Number of Participants With Best Overall Response (BOR) [ Time Frame: Day 0 (predose), assessed every 8 weeks (2 cycles) until disease progression, unacceptable toxicity, or withdrawal for other reasons (up to Week 133) ]BOR: best response recorded from treatment start until disease progression/recurrence based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): disappearance of all lesions. Partial Response (PR): >=30% decrease in sum of longest diameters (SLDs) of target lesions taking as reference baseline SLDs, associated to non-progressive disease (non-PD) response for non-target (NT) lesions. PD: >=20% increase in SLDs of target lesions taking as reference smallest SLDs since treatment start, or appearance of >=1 new lesion, or unequivocal progression in NT lesions. Stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest SLDs since treatment start. CR and PR had to be confirmed on a follow up imaging assessment >=4 weeks after initial objective documentation of response. SD criteria should be met at least once after start of treatment in a minimum interval of 8 weeks. Participants with >=3 treatments cycles were reported.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879684
|United States, Arizona|
|Scottsdale Medical Imaging, Ltd.|
|Scottsdale, Arizona, United States, 85255|
|Premiere Oncology of Arizona|
|Scottsdale, Arizona, United States, 85258|
|United States, California|
|Premiere Oncology, A Medical Corporation|
|Santa Monica,, California, United States, 90404|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|