Pazopanib (VOTRIENT) Plus Paclitaxel (TAXOL), Pazopanib Plus Paclitaxel (TAXOL) Plus Carboplatin (PARAPLATIN), and Pazopanib Plus Paclitaxel (TAXOL) Plus Lapatinib (TYKERB)
A Phase I, Open-Label, Study of the Safety, Tolerability, and Pharmacokinetics of Pazopanib in Combination With Paclitaxel on a Weekly Schedule for Three Consecutive Weeks of a 28-Day Cycle, Paclitaxel and Carboplatin on an Every 21 Days Schedule and Lapatinib and Paclitaxel on a Weekly Schedule for Three Consecutive Weeks of a 28- Day Cycle
1 other identifier
interventional
86
1 country
3
Brief Summary
Pazopanib will be given with TAXOL in one part, in another part pazopanib will be given with TAXOL and PARAPLATIN, and in a third part pazopanib will be given with TAXOL and lapatinib (patients separated in each part). Toxicity monitoring will enable us to find the largest dose of pazopanib daily that can be safely given in combination with the chemotherapy agents TAXOL and PARAPLATIN, and with lapatinib, as well as what side effects are likely to manifest when these agents are given together and whether the combination of pazopanib with chemotherapy, helps to treat different types of cancer. Another objective is to find out how much pazopanib, TAXOL, PARAPLATIN and lapatinib are in the blood at specific times after the agents are given. Collecting the blood samples requires that the patients remain in the vicinity of the clinic overnight on 2 occasions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2006
Typical duration for phase_1
3 active sites
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
April 28, 2006
CompletedFirst Submitted
Initial submission to the registry
October 11, 2006
CompletedFirst Posted
Study publicly available on registry
October 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2009
CompletedNovember 17, 2017
November 1, 2017
3.2 years
October 11, 2006
November 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse Effects, Laboratory parameters
before and after taking the study medications.
Secondary Outcomes (2)
Blood samples
over a 24 hour period
Tumors
will be measured at routine intervals throughout (e.g. by CT scan).
Study Arms (3)
Part 1
EXPERIMENTALpazopanib and paclitaxel
Part 2
EXPERIMENTALpazopanib, paclitaxel, and carboplatin
Part 3
EXPERIMENTALpazopanib, paclitaxel, and lapatinib
Interventions
pazopanib in combination with paclitaxel in Part 1, paclitaxel and carboplatin in Part 2, and paclitaxel and lapatinib in Part 3
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of cancer, except cervical cancer
- Eastern Cooperative Oncology Group performance Status of 0 or 1
- Peripheral neuropathy of Grade 1 or less
- Adequate bone marrow function (absolute neutrophils, platelets and hemoglobin levels as per protocol)
- Adequate renal function as per protocol
- Urine creatinine ratio as per protocol
- Adequate hepatic function as per protocol
- Coagulation tests as per protocol
- Male of female at least 18 years of age
- A woman is eligible to enter and participate in the study if she is of:
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any woman who:
- Has had a hysterectomy,
- Has had a bilateral oophorectomy (ovariectomy),
- Has had a bilateral tubal ligation,
- Is post-menopausal (total cessation of menses for at least 1 year)
- +8 more criteria
You may not qualify if:
- No more than 3 prior lines of cytotoxic chemotherapy for metastatic disease are allowed.
- No major surgery, nor cytotoxic chemotherapy, investigational agents, or radiotherapy within the last 28 days and subject must have recovered fully from whatever their last treatment was at the time of enrollment.
- Women who are pregnant or breast feeding are not eligible to enroll.
- Cannot have poorly controlled hypertension.
- Cannot have corrected QT (QTc) prolongation
- Cannot have Class III or IV heart failure as defined by the New York Heart Association functional classification system.
- Cannot have arterial or venous thrombi (including cerebrovascular accident), myocardial infarction, admission for unstable angina, cardiac angioplasty, or stenting within the last 3 months.
- Cannot use of therapeutic warfarin.
- Cannot have history of bleeding (hemoptysis, hematuria, GI blood loss, epistaxis, or others with greater than Grade 1 according to CTC Criteria) within six weeks prior to beginning therapy or any clinical indications of current active bleeding or bleeding diathesis.
- Cannot have history or clinical evidence of CNS metastases or leptomeningeal carcinomatosis, except for individuals who have previously treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 2 months prior to beginning study treatment.
- Cannot have any serious and/or unstable pre-existing medical, psychiatric, or other condition (including laboratory abnormalities) that could interfere with patient safety or obtaining consent.
- Cannot have history of malabsorption syndrome, disease significantly affecting gastrointestinal function or major resection of the stomach or small bowel that could affect absorption, distribution, metabolism or excretion of pazopanib, paclitaxel, or carboplatin. Has any unresolved bowel obstruction or diarrhea. Has clinically significant gastrointestinal abnormalities that may increase the risk for GI bleeding including, but not limited to:
- active peptic ulcer disease,
- known intraluminal metastatic lesion(s) with suspected bleeding,
- inflammatory bowel disease including ulcerative colitis, or other GI conditions with increased risk of perforation,
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (3)
GSK Investigational Site
New Brunswick, New Jersey, 08901, United States
GSK Investigational Site
Cleveland, Ohio, 44106, United States
GSK Investigational Site
Nashville, Tennessee, 37203, United States
Related Publications (3)
Burris HA 3rd, Dowlati A, Moss RA, Infante JR, Jones SF, Spigel DR, Levinson KT, Lindquist D, Gainer SD, Dar MM, Suttle AB, Ball HA, Tan AR. Phase I study of pazopanib in combination with paclitaxel and carboplatin given every 21 days in patients with advanced solid tumors. Mol Cancer Ther. 2012 Aug;11(8):1820-8. doi: 10.1158/1535-7163.MCT-11-0997. Epub 2012 Jun 7.
PMID: 22679111BACKGROUNDTan AR, Dowlati A, Jones SF, Infante JR, Nishioka J, Fang L, Hodge JP, Gainer SD, Arumugham T, Suttle AB, Dar MM, Lager JJ, Burris HA 3rd. Phase I study of pazopanib in combination with weekly paclitaxel in patients with advanced solid tumors. Oncologist. 2010;15(12):1253-61. doi: 10.1634/theoncologist.2010-0095. Epub 2010 Dec 8.
PMID: 21147873BACKGROUNDTan AR, Dowlati A, Stein MN, Jones SF, Infante JR, Bendell J, Kane MP, Levinson KT, Suttle AB, Burris HA 3rd. Phase I study of weekly paclitaxel in combination with pazopanib and lapatinib in advanced solid malignancies. Br J Cancer. 2014 May 27;110(11):2647-54. doi: 10.1038/bjc.2014.233. Epub 2014 May 6.
PMID: 24800949DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2006
First Posted
October 13, 2006
Study Start
April 28, 2006
Primary Completion
July 21, 2009
Study Completion
July 21, 2009
Last Updated
November 17, 2017
Record last verified: 2017-11