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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

This study has been terminated.
(Refer to statement in Summary Section/Detailed Description)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00982657
First received: September 22, 2009
Last updated: October 16, 2015
Last verified: October 2015
  Purpose
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).

Condition Intervention Phase
Solid Tumor
Drug: CVX-060 + sunitinib
Drug: Sunitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) [ Time Frame: Baseline up to Cycle 1( Day 1 to Day 42) ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Baseline tumor progression/clinical deterioration or death (up to 28 days post last dose of study medication) ] [ Designated as safety issue: No ]
    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 [ 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) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline up to 28 days post last dose of study medication ] [ Designated as safety issue: Yes ]
    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 [ 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) ] [ Designated as safety issue: No ]
  • Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs) [ Time Frame: Baseline up to 28 days post last dose of study medication ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline up to 7 days post last dose of study medication ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline up to 7 days post last dose of study medication ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline up to 28 days after last CVX-060 dose ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: September 2009
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
CVX-060 + sunitinib
Drug: CVX-060 + sunitinib
CVX-060 weekly infusions at 6.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)
Other Name: CVX-060 / Sutent
Experimental: Cohort 2
CVX-060 + sunitinib
Drug: CVX-060 + sunitinib
CVX-060 weekly infusions at 12.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)
Other Name: CVX-060 / Sutent
Experimental: Cohort 3
CVX-060 + sunitinib
Drug: CVX-060 + sunitinib
CVX-060 weekly infusions at 15.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)
Other Name: CVX-060 / Sutent
Experimental: Expanded cohort
CVX-060 + sunitinib
Drug: CVX-060 + sunitinib
CVX-060 weekly infusions at TBD mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)
Other Name: CVX-060 / Sutent
Experimental: Phase II - Arm A
CVX-060 + sunitinib
Drug: CVX-060 + sunitinib
CVX-060 weekly infusions at TBD mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)
Other Name: CVX-060 / Sutent
Active Comparator: Phase II - Arm B
sunitinib alone
Drug: Sunitinib
50 mg sunitinib daily (4 out of 6 weeks)
Other Name: Sutent

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00982657

Locations
United States, Arizona
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, Mississippi
Boston Baskin Cancer Foundation
Southaven, Mississippi, United States, 38671
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Tennessee
Boston Baskin Cancer Foundation
Bartlett, Tennessee, United States, 38133
Boston Baskin Cancer Foundation
Germantown, Tennessee, United States, 38138
Boston Baskin Cancer Foundation
Memphis, Tennessee, United States, 38120
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00982657     History of Changes
Other Study ID Numbers: B1131001  CVX-060-102  2010-022657-42 
Study First Received: September 22, 2009
Results First Received: March 13, 2015
Last Updated: October 16, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase Ib Phase II Advanced solid tumor Clear cell renal cancer Sunitinib plus / minus CVX-060

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Angiogenesis Inhibitors
Antineoplastic Agents
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 26, 2016