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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

NCT ID: NCT00982657

Last Updated: 2015-11-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2014-03-31

Brief Summary

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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

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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.

Conditions

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Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

CVX-060 + sunitinib

Group Type EXPERIMENTAL

CVX-060 + sunitinib

Intervention Type DRUG

CVX-060 weekly infusions at 6.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)

Cohort 2

CVX-060 + sunitinib

Group Type EXPERIMENTAL

CVX-060 + sunitinib

Intervention Type DRUG

CVX-060 weekly infusions at 12.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)

Cohort 3

CVX-060 + sunitinib

Group Type EXPERIMENTAL

CVX-060 + sunitinib

Intervention Type DRUG

CVX-060 weekly infusions at 15.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)

Expanded cohort

CVX-060 + sunitinib

Group Type EXPERIMENTAL

CVX-060 + sunitinib

Intervention Type DRUG

CVX-060 weekly infusions at TBD mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)

Phase II - Arm A

CVX-060 + sunitinib

Group Type EXPERIMENTAL

CVX-060 + sunitinib

Intervention Type DRUG

CVX-060 weekly infusions at TBD mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)

Phase II - Arm B

sunitinib alone

Group Type ACTIVE_COMPARATOR

Sunitinib

Intervention Type DRUG

50 mg sunitinib daily (4 out of 6 weeks)

Interventions

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CVX-060 + sunitinib

CVX-060 weekly infusions at 6.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)

Intervention Type DRUG

CVX-060 + sunitinib

CVX-060 weekly infusions at 12.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)

Intervention Type DRUG

CVX-060 + sunitinib

CVX-060 weekly infusions at 15.0 mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)

Intervention Type DRUG

CVX-060 + sunitinib

CVX-060 weekly infusions at TBD mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)

Intervention Type DRUG

CVX-060 + sunitinib

CVX-060 weekly infusions at TBD mg/kg + 50 mg sunitinib daily (4 out of 6 weeks)

Intervention Type DRUG

Sunitinib

50 mg sunitinib daily (4 out of 6 weeks)

Intervention Type DRUG

Other Intervention Names

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CVX-060 / Sutent CVX-060 / Sutent CVX-060 / Sutent CVX-060 / Sutent CVX-060 / Sutent Sutent

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Premiere Oncology of Arizona

Scottsdale, Arizona, United States

Site Status

Premiere Oncology, A Medical Corporation

Santa Monica, California, United States

Site Status

Boston Baskin Cancer Foundation

Southaven, Mississippi, United States

Site Status

Providence Portland Medical Center

Portland, Oregon, United States

Site Status

Boston Baskin Cancer Foundation

Bartlett, Tennessee, United States

Site Status

Boston Baskin Cancer Foundation

Germantown, Tennessee, United States

Site Status

Boston Baskin Cancer Foundation

Memphis, Tennessee, United States

Site Status

Countries

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United States

Related Links

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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

To obtain contact information for a study center near you, click here.

Other Identifiers

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CVX-060-102

Identifier Type: OTHER

Identifier Source: secondary_id

2010-022657-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B1131001

Identifier Type: -

Identifier Source: org_study_id