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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NCT00982657

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Study Location
Premiere Oncology of Arizona
Scottsdale, Arizona, 85258, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Solid Tumor
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Trial Of CVX-060, An Anti-Angiogenic COVX-Body, In Combination With Sunitinib In Patients With Advanced Renal Cell Carcinoma
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor
Intervention  ICMJE
  • 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
  • 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
  • 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
  • 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
  • Drug: Sunitinib
    50 mg sunitinib daily (4 out of 6 weeks)
    Other Name: Sutent
Study Arms  ICMJE
  • Experimental: Cohort 1
    CVX-060 + sunitinib
    Intervention: Drug: CVX-060 + sunitinib
  • Experimental: Cohort 2
    CVX-060 + sunitinib
    Intervention: Drug: CVX-060 + sunitinib
  • Experimental: Cohort 3
    CVX-060 + sunitinib
    Intervention: Drug: CVX-060 + sunitinib
  • Experimental: Expanded cohort
    CVX-060 + sunitinib
    Intervention: Drug: CVX-060 + sunitinib
  • Experimental: Phase II - Arm A
    CVX-060 + sunitinib
    Intervention: Drug: CVX-060 + sunitinib
  • Active Comparator: Phase II - Arm B
    sunitinib alone
    Intervention: Drug: Sunitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 4, 2014)		34
Original Estimated Enrollment  ICMJE
 (submitted: September 22, 2009)		124
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00982657
Other Study ID Numbers  ICMJE B1131001
CVX-060-102 ( Other Identifier: Alias Study Number )
2010-022657-42 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP