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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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NCT00982657

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Premiere Oncology of Arizona
Scottsdale, Arizona, 85258 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

NCT00982657
Pfizer
Terminated
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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A Trial Of CVX-060, An Anti-Angiogenic COVX-Body, In Combination With Sunitinib In Patients With Advanced Renal Cell Carcinoma
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
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).
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.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Solid Tumor
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
34
March 2014
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00982657
B1131001
CVX-060-102 ( Other Identifier: Alias Study Number )
2010-022657-42 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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