Back to resultsA Trial Of CVX-060, An Anti-Angiogenic COVX-Body, In Combination With Sunitinib In Patients With Advanced Renal Cell Carcinoma
Primary Purpose
Solid Tumor
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CVX-060 + sunitinib
CVX-060 + sunitinib
CVX-060 + sunitinib
CVX-060 + sunitinib
CVX-060 + sunitinib
Sunitinib
Sponsored by
About this trial
This is an interventional treatment trial for Solid Tumor focused on measuring Phase Ib Phase II Advanced solid tumor Clear cell renal cancer Sunitinib plus / minus CVX-060
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
Sites / Locations
- Premiere Oncology of Arizona
- Premiere Oncology, A Medical Corporation
- Boston Baskin Cancer Foundation
- Providence Portland Medical Center
- Boston Baskin Cancer Foundation
- Boston Baskin Cancer Foundation
- Boston Baskin Cancer Foundation
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Cohort 1
Cohort 2
Cohort 3
Expanded cohort
Phase II - Arm A
Phase II - Arm B
Arm Description
CVX-060 + sunitinib
CVX-060 + sunitinib
CVX-060 + sunitinib
CVX-060 + sunitinib
CVX-060 + sunitinib
sunitinib alone
Outcomes
Primary Outcome Measures
Maximum Tolerated Dose (MTD)
The MTD was defined as the dose level at which less than or equal to (<=) 1/6 participants experienced Dose Limiting Toxicity (DLT) during the first cycle of treatment with the next higher dose having >= 2/6 participants with DLT.
Progression-free Survival (PFS)
PFS was defined as the time from the first dose date to the first documentation of disease progression or death due to any cause, whichever occurred first.
Secondary Outcome Measures
Pharmacokinetic Parameters of CVX-060
Pharmacokinetic parameters Area under the Curve (AUC), Maximum Observed Serum Concentration (Cmax), Minimum Observed Serum Trough Concentration (Cmin), Clearance (CL), terminal elimination half life (t1/2) were planned to be analyzed.
Number of Participants With Dose-limiting Toxicities (DLT)
DLT included grade 4 neutropenia of >= 3 day duration or with grade 4 neutropenia associated with fever; grade 4 thrombocytopenia for >= 3 consecutive days; Proteinuria of >=2 grams (g) per 24 hours; inability to resume to CVX-060 or sunitinib within 14 days of scheduled administration due to treatment related toxicity; any Grade 3 nonhematologic toxicity except nausea, vomiting, and diarrhea; Grade 3 nausea, vomiting, or diarrhea which persists for >=48 hours; Any >= Grade 4 non-hematologic toxicity; Any additional hematological or non-hematological toxicity for which dose reduction was required or for which patient was discontinued from the trial.
Serum Angiopoietin-2 (Ang-2) and Plasma Vascular Endothelial Growth Factor (VEGF) Levels
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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 28 days after last dose that were absent before treatment or that worsened relative to pre treatment state.
Percentage of Participants With Objective Response
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as >= 30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions.
Duration of Response
Duration of response is defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or death due to any cause, whichever occurs first. Participants last known to be progression free are censored at the date of the last objective disease assessment that verified lack of disease progression.
Number of Participants With Anti- CVX-060 Antibodies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00982657
Brief Title
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
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Why Stopped
Refer to statement in Summary Section/Detailed Description
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor
Keywords
Phase Ib Phase II Advanced solid tumor Clear cell renal cancer Sunitinib plus / minus CVX-060
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
CVX-060 + sunitinib
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
CVX-060 + sunitinib
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
CVX-060 + sunitinib
Arm Title
Expanded cohort
Arm Type
Experimental
Arm Description
CVX-060 + sunitinib
Arm Title
Phase II - Arm A
Arm Type
Experimental
Arm Description
CVX-060 + sunitinib
Arm Title
Phase II - Arm B
Arm Type
Active Comparator
Arm Description
sunitinib alone
Intervention Type
Drug
Intervention Name(s)
CVX-060 + sunitinib
Other Intervention Name(s)
CVX-060 / Sutent
Intervention Description
CVX-060 weekly infusions at 6.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)
Intervention Type
Drug
Intervention Name(s)
CVX-060 + sunitinib
Other Intervention Name(s)
CVX-060 / Sutent
Intervention Description
CVX-060 weekly infusions at 12.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)
Intervention Type
Drug
Intervention Name(s)
CVX-060 + sunitinib
Other Intervention Name(s)
CVX-060 / Sutent
Intervention Description
CVX-060 weekly infusions at 15.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)
Intervention Type
Drug
Intervention Name(s)
CVX-060 + sunitinib
Other Intervention Name(s)
CVX-060 / Sutent
Intervention Description
CVX-060 weekly infusions at TBD mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)
Intervention Type
Drug
Intervention Name(s)
CVX-060 + sunitinib
Other Intervention Name(s)
CVX-060 / Sutent
Intervention Description
CVX-060 weekly infusions at TBD mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)
Intervention Type
Drug
Intervention Name(s)
Sunitinib
Other Intervention Name(s)
Sutent
Intervention Description
50 mg sunitinib daily (4 out of 6 weeks)
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose (MTD)
Description
The MTD was defined as the dose level at which less than or equal to (<=) 1/6 participants experienced Dose Limiting Toxicity (DLT) during the first cycle of treatment with the next higher dose having >= 2/6 participants with DLT.
Time Frame
Baseline up to Cycle 1( Day 1 to Day 42)
Title
Progression-free Survival (PFS)
Description
PFS was defined as the time from the first dose date to the first documentation of disease progression or death due to any cause, whichever occurred first.
Time Frame
Baseline tumor progression/clinical deterioration or death (up to 28 days post last dose of study medication)
Secondary Outcome Measure Information:
Title
Pharmacokinetic Parameters of CVX-060
Description
Pharmacokinetic parameters Area under the Curve (AUC), Maximum Observed Serum Concentration (Cmax), Minimum Observed Serum Trough Concentration (Cmin), Clearance (CL), terminal elimination half life (t1/2) were planned to be analyzed.
Time Frame
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)
Title
Number of Participants With Dose-limiting Toxicities (DLT)
Description
DLT included grade 4 neutropenia of >= 3 day duration or with grade 4 neutropenia associated with fever; grade 4 thrombocytopenia for >= 3 consecutive days; Proteinuria of >=2 grams (g) per 24 hours; inability to resume to CVX-060 or sunitinib within 14 days of scheduled administration due to treatment related toxicity; any Grade 3 nonhematologic toxicity except nausea, vomiting, and diarrhea; Grade 3 nausea, vomiting, or diarrhea which persists for >=48 hours; Any >= Grade 4 non-hematologic toxicity; Any additional hematological or non-hematological toxicity for which dose reduction was required or for which patient was discontinued from the trial.
Time Frame
Baseline up to 28 days post last dose of study medication
Title
Serum Angiopoietin-2 (Ang-2) and Plasma Vascular Endothelial Growth Factor (VEGF) Levels
Time Frame
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)
Title
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs)
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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 28 days after last dose that were absent before treatment or that worsened relative to pre treatment state.
Time Frame
Baseline up to 28 days post last dose of study medication
Title
Percentage of Participants With Objective Response
Description
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. Per RECIST v1.0: CR defined as disappearance of all target lesions and non-target lesions. PR defined as >= 30% decrease in sum of the longest diameters (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST associated to non-progressive disease response for non target lesions.
Time Frame
Baseline up to 7 days post last dose of study medication
Title
Duration of Response
Description
Duration of response is defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or death due to any cause, whichever occurs first. Participants last known to be progression free are censored at the date of the last objective disease assessment that verified lack of disease progression.
Time Frame
Baseline up to 7 days post last dose of study medication
Title
Number of Participants With Anti- CVX-060 Antibodies
Time Frame
Baseline up to 28 days after last CVX-060 dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Premiere Oncology of Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Premiere Oncology, A Medical Corporation
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Boston Baskin Cancer Foundation
City
Southaven
State/Province
Mississippi
ZIP/Postal Code
38671
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Boston Baskin Cancer Foundation
City
Bartlett
State/Province
Tennessee
ZIP/Postal Code
38133
Country
United States
Facility Name
Boston Baskin Cancer Foundation
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Boston Baskin Cancer Foundation
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1131001&StudyName=A%20Trial%20Of%20CVX-060%2C%20An%20Anti-Angiogenic%20COVX-Body%2C%20In%20Combination%20With%20Sunitinib%20In%20Patients%20With%20Advanced%20Renal%20Cell%20Carcinoma
Description
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A Trial Of CVX-060, An Anti-Angiogenic COVX-Body, In Combination With Sunitinib In Patients With Advanced Renal Cell Carcinoma
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