NCT00459862

Brief Summary

This phase II trial is studying the side effects and how well pazopanib works in treating patients with malignant pleural mesothelioma. Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 13, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
7 months until next milestone

Results Posted

Study results publicly available

December 5, 2013

Completed
Last Updated

February 24, 2015

Status Verified

October 1, 2013

Enrollment Period

2.1 years

First QC Date

April 11, 2007

Results QC Date

October 7, 2013

Last Update Submit

January 28, 2015

Conditions

Advanced Malignant MesotheliomaLocalized Malignant MesotheliomaRecurrent Malignant Mesothelioma

Outcome Measures

Primary Outcomes (1)

  • Proportion of Evaluable Participants Who Are Progression-free at 6 Months Based on the Response Evaluation Criteria for Solid Tumors (RECIST)

    The proportion of patients who are progression-free at 6 months is calculated by dividing the number of evaluable participants who are progression-free at 6 months based on the Response Evaluation Criteria for Solid Tumors (RECIST) by the total number of evaluable participants.

    6 months

Secondary Outcomes (5)

  • Overall Survival

    From study enrollment to time of death from any cause or censored at last follow-up, up to 3 years

  • Progression-free Survival Assessed by RECIST

    From study enrollment to the first date of disease progression or death as a result of any cause, whichever occurs first, up to 3 years

  • Determine the Clinical Toxicities of This Drug in This Participant Population.

    Participants will be evaluated every cycle during treatment

  • Overall Best Response of Target Lesions to Pazopanib in Patients With MPM Based on the RECIST.

    From study enrollment to the first date of disease progression

  • Overall Response Rate

    Participants will be evaluated every cycle during treatment, up to 2 years

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.

Other: laboratory biomarker analysisDrug: pazopanib hydrochloride

Interventions

laboratory biomarker analysisOTHER

Correlative study

Arm I
pazopanib hydrochlorideDRUG

Given orally

Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed malignant pleural mesothelioma:
  • Measurable disease
  • No progressive disease inside or outside of any prior radiation field
  • No symptomatic, untreated, or uncontrolled CNS metastases
  • Patients with CNS metastases treated with whole brain radiation (WBRT) may be enrolled after completion of WBRT
  • Patients may begin study therapy as early as the next day after completion of WBRT
  • ECOG performance status 0-2
  • Life expectancy \>= 12 weeks
  • ANC \>=1,500/mm\^3
  • Platelet count \>= 100,000/mm\^3
  • WBC \>= 3,000/mm\^3
  • Bilirubin =\< 1.5 times upper limit of normal (ULN)
  • AST and ALT =\< 2.5 times ULN
  • Alkaline phosphatase =\< 2.5 times ULN
  • Creatinine =\< 1.5 times ULN or creatinine clearance \>= 50 mL/min
  • +48 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Central Cancer Treatment Group

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Parikh K, Mandrekar SJ, Allen-Ziegler K, Esplin B, Tan AD, Marchello B, Adjei AA, Molina JR. A Phase II Study of Pazopanib in Patients with Malignant Pleural Mesothelioma: NCCTG N0623 (Alliance). Oncologist. 2020 Jun;25(6):523-531. doi: 10.1634/theoncologist.2019-0574. Epub 2019 Dec 24.

    PMID: 31872928DERIVED

MeSH Terms

Conditions

Mesothelioma, Malignant

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Julian Molina, M.D, Ph.D.
Organization
Mayo Clinic
Molina.julian@mayo.edu

Study Officials

  • Julian Molina

    North Central Cancer Treatment Group

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2007

First Posted

April 13, 2007

Study Start

March 1, 2007

Primary Completion

April 1, 2009

Study Completion

May 1, 2013

Last Updated

February 24, 2015

Results First Posted

December 5, 2013

Record last verified: 2013-10

Locations

US(1)