Clinical trial NCT00982657: A Trial Of CVX-060, An Anti-Angiogenic COVX-Body, In Combination With Sunitinib In Patients With Advanced Renal Cell Carcinoma
Official title: A Phase Ib/ii, Multicenter, Trial Of Cvx-060, A Selective Angiopoietin-2 (Ang-2) Binding, Anti-angiogenic Covx-body, In Combination With Sunitinib In Patients With Advanced Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Solid Tumor
Keywords: Phase Ib Phase II Advanced solid tumor Clear cell renal cancer Sunitinib plus / minus CVX-060
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-09-23
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 safety and tolerability of CVX-060 have been established in the first-in-human clinical trial, CVX-060-101. Thus, this phase Ib/II trial is to assess the safety and pharmacokinetics (PK) profiles of combining CVX-060 with sunitinib in patients with advanced solid tumors, and to subsequently assess the treatment efficacy of the combination treatment, as well as that of sunitinib alone in patients with advanced renal cell carcinoma (mRCC).

Detailed description: On 23-Nov-2010, B1131001 (CVX-060-102) was closed to enrollment due to emerging clinical data which led to a re-assessment of the strategic goals of the PF-04856884 program. The study enrolled the Phase 1b portion only. Subsequently, on 25-Oct-2012, due to data safety signals in a separate clinical trial with PF-04856884 (CVX-060), all PF-04856884 studies were discontinued and ongoing patients on B1131001 were permitted to remain on study at a reduced PF-04856884 dose if determined to have been deriving clinical benefit.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed advanced/metastatic solid tumor
* Having received at least 1 prior systemic therapy for the treatment of advanced/metastatic solid tumors
* Histologically or cytologically confirmed renal cell carcinoma with clear cell histology and evidence of metastasis (No previous systemic therapy for the treatment of metastatic renal cell carcinoma)
* Adequate laboratory tests
* Eastern Cooperative Oncology Group (ECOG) 0-1, Life expectancy \> or = 12 weeks and age \> or = 18 years

Exclusion Criteria:

* Patients intolerant of prior anti-angiogenic agents
* Recent history of bleeding or bleeding disorders
* History of tumors in the brain
* History of heart problems
* History of severe allergic reaction to antibody therapy

Primary outcomes:
measure: Maximum Tolerated Dose (MTD)
timeFrame: Baseline up to Cycle 1( Day 1 to Day 42)
measure: Progression-free Survival (PFS)
timeFrame: Baseline tumor progression/clinical deterioration or death (up to 28 days post last dose of study medication)
Secondary outcomes:
measure: Pharmacokinetic Parameters of CVX-060
timeFrame: Pre-dose on Day 1 Cycle 1 ; post-dose on Day 1, 5, 8, 15, 22, 29 Cycle 1 , Day 1 Cycle 2, to Cycle 28 , end of study (7 days post last dose of study medication), follow-up visit (28 days post last dose of study medication)
measure: Number of Participants With Dose-limiting Toxicities (DLT)
timeFrame: Baseline up to 28 days post last dose of study medication
measure: Serum Angiopoietin-2 (Ang-2) and Plasma Vascular Endothelial Growth Factor (VEGF) Levels
timeFrame: Ang-2 (Day 1, 2, 5, 8, 22, 29 Cycle 1, Day 1 Cycle 2 up to Cycle 28); VEGF (Day 1, 8, 15, 22 Cycle 1, Day 1 Cycle 2 up to Cycle 28)
measure: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs)
timeFrame: Baseline up to 28 days post last dose of study medication
measure: Percentage of Participants With Objective Response
timeFrame: Baseline up to 7 days post last dose of study medication
measure: Duration of Response
timeFrame: Baseline up to 7 days post last dose of study medication
measure: Number of Participants With Anti- CVX-060 Antibodies
timeFrame: Baseline up to 28 days after last CVX-060 dose
Other outcomes:
Locations:
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: Southaven
country: United States
facility: Boston Baskin Cancer Foundation
state: Mississippi
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Bartlett
country: United States
facility: Boston Baskin Cancer Foundation
state: Tennessee
city: Germantown
country: United States
facility: Boston Baskin Cancer Foundation
state: Tennessee
city: Memphis
country: United States
facility: Boston Baskin Cancer Foundation
state: Tennessee
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: