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A Safety, Tolerability, And Pharmacokinetic Trial With CVX-241 In Patients With Advanced Solid Tumors

NCT ID: NCT01004822

Last Updated: 2015-11-20

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2014-05-31

Brief Summary

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The purpose of this study is to determine if CVX-241 (PF-05057459) is safe and tolerable when given as weekly infusions to adult patients with advanced solid tumors.

Detailed Description

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The study was prematurely discontinued on 14 September 2011 due to no significant pharmacological effects (safety/PD/efficacy) through 25 mg/kg cohort, the T1/2 based on VEGF binding was shorter than expected and the current and/or higher doses were not considered feasible for further development. There were no safety concerns associated with the decision to terminate the program/study.

Conditions

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Advanced Solid Tumors

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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Active Drug

Weekly infusions of CVX-241 at specified doses

Group Type EXPERIMENTAL

CVX-241

Intervention Type DRUG

0.3 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.

CVX-241

Intervention Type DRUG

1 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.

CVX-241

Intervention Type DRUG

3 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.

CVX-241

Intervention Type DRUG

6 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.

CVX-241

Intervention Type DRUG

12 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.

CVX-241

Intervention Type DRUG

15 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.

CVX-241

Intervention Type DRUG

18 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.

CVX-241

Intervention Type DRUG

25 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.

Interventions

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CVX-241

0.3 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.

Intervention Type DRUG

CVX-241

1 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.

Intervention Type DRUG

CVX-241

3 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.

Intervention Type DRUG

CVX-241

6 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.

Intervention Type DRUG

CVX-241

12 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.

Intervention Type DRUG

CVX-241

15 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.

Intervention Type DRUG

CVX-241

18 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.

Intervention Type DRUG

CVX-241

25 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.

Intervention Type DRUG

Other Intervention Names

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PF-05057459 PF-05057459 PF-05057459 PF-05057459 PF-05057459 PF-05057459 PF-05057459 PF-05057459

Eligibility Criteria

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Inclusion Criteria

* Confirmed solid tumors unresponsive to current therapy or for which there is no standard therapy.
* Stage 2 only: Histologically or cytologically documented EOC or PPC with \< or equal to 3 previous anti-cancer therapies, but at least 1 prior platinum containing regimen.
* Adequate coagulation, liver, and renal function.
* Candidate for Dynamic Contrast-Enhanced Magnetic Resonance Imaging \[DCE-MRI\] evaluation
* Eastern Cooperative Oncology Group \[ECOG\] performance status of 0 or 1

Exclusion Criteria

* History of clinically significant toxicity to Vascular Endothelial Growth Factor \[VEGF\] inhibition.
* Evidence of bleeding problems.
* Uncontrolled hypertension.
* Patients with primary brain cancer and/or non-small cell lung cancer of squamous cell histology
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

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 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=B1561001&StudyName=A%20Safety%2C%20Tolerability%2C%20And%20Pharmacokinetic%20Trial%20With%20CVX-241%20In%20Patients%20With%20Advanced%20Solid%20Tumors

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

Other Identifiers

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CVX-241-101

Identifier Type: OTHER

Identifier Source: secondary_id

B1561001

Identifier Type: -

Identifier Source: org_study_id