Study To Assess Long Term Safety Of Pazopanib

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00387205
• Collaborator: (none)
• Enrollment: 188
• Locations: 19
• Arm: 1
• Actual Duration (Months): 140.6
• Patients Per Site: 9.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study was a rollover study to evaluate the long term safety of pazopanib and to continue to provide pazopanib to patients who participated in a GSK sponsored pazopanib study until pazopanib is available commercially.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Renal Cell	Drug: Pazopanib	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 188 participants
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Phase Ib Study to Assess the Long Term Safety Profile of Pazopanib in Cancer Patients
• Actual Study Start Date: Jun 20, 2006
• Actual Primary Completion Date: Feb 13, 2013
• Actual Study Completion Date: Mar 8, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Pazopanib monotherapy or in combination with lapatinib or other approved anti-cancer medications	Drug: Pazopanib; Pazopanib monotherapy or in combination with lapatinib or other approved anti-cancer medications

Outcome Measures

Primary Outcome Measures

1. To evaluate the long-term safety of repeat daily doses of pazopanib in cancer subjects with solid tumors [Subjects will stay on the study as long as they are benefiting from treatment, have not met one of the stopping criteria, or experienced a toxicity up to 72 months.]

   To evaluate the safety assessments; adverse events, vital signs, physical examinations, electrocardiograms, multi-gated acquisition scans or echocardiograms (only for patients on pazopanib and lapatinib combination therapy), and clinical laboratory assessments.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

• Participated or completed a GSK sponsored pazopanib study and remains eligible for continued treatment with pazopanib and lapatinib (if on combination therapy).

• Able to understand and provide written informed consent

• Women and men agree to use protocol specific birth control measures

Key Exclusion Criteria:

• The subject has a treatment related serious adverse event that remains unresolved or unstable or had pazopanib permanently stopped in a previous study because of intolerate or because it was unsuccessful in treating your cancer

• If you are pregnant or breast feeding

• Your doctor does not think you would be a good candidate for the study

• Poorly controlled high blood pressure

• Subject is unwilling or unable to follow the procedures outlined in the protocol.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Duarte	California	United States	91010
2	Novartis Investigative Site	Santa Monica	California	United States	90404
3	Novartis Investigative Site	Aurora	Colorado	United States	80045
4	Novartis Investigative Site	Indianapolis	Indiana	United States	46202
5	Novartis Investigative Site	Detroit	Michigan	United States	48201
6	Novartis Investigative Site	Minneapolis	Minnesota	United States	55404
7	Novartis Investigative Site	Lebanon	New Hampshire	United States	03756
8	Novartis Investigative Site	New Brunswick	New Jersey	United States	08901
9	Novartis Investigative Site	Buffalo	New York	United States	14263
10	Novartis Investigative Site	Durham	North Carolina	United States	27710
11	Novartis Investigative Site	Cleveland	Ohio	United States	44106
12	Novartis Investigative Site	Greenville	South Carolina	United States	29605
13	Novartis Investigative Site	Nashville	Tennessee	United States	37203
14	Novartis Investigative Site	Houston	Texas	United States	77030-4009
15	Novartis Investigative Site	Tacoma	Washington	United States	98405
16	Novartis Investigative Site	Lyon Cedex 08		France	69373
17	Novartis Investigative Site	Singapore		Singapore	119074
18	Novartis Investigative Site	Sutton	Surrey	United Kingdom	SM2 5PT
19	Novartis Investigative Site	Newcastle Upon Tyne		United Kingdom	NE7 7DN

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00387205
• Other Study ID Numbers: VEG105430; 2006-005528-17
• First Posted: Oct 12, 2006
• Last Update Posted: Mar 6, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Novartis Pharmaceuticals: chronic administration; monotherapy and combination therapies; solid; lapatinib (TYKERB, TYVERB); malignant tumor; Pazopanib; GW786034; cancer; safety
• Additional relevant MeSH terms: Carcinoma, Renal Cell

Study Results

No Results Posted as of Mar 6, 2019