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Neoplasms, BreastPhase 1NCT00388076

Pazopanib (VOTRIENT) Plus Paclitaxel (TAXOL), Pazopanib Plus Paclitaxel (TAXOL) Plus Carboplatin (PARAPLATIN), and Pazopanib Plus Paclitaxel (TAXOL) Plus Lapatinib (TYKERB)

A Phase 1 study testing Pazopanib, Lapatinib and paclitaxel in people with Neoplasms, Breast, run by GlaxoSmithKline at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms, Breast
What is being tested?
Pazopanib, Lapatinib and paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
3 sitesUnited States
Study dates
28 Apr 2006to 21 Jul 2009
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)
  • Childbearing potential, has a negative serum or urine pregnancy test at screening, and agrees to one of the following:
  • An intrauterine device (IUD) with a documented failure rate of less than 1% per year.
  • Vasectomized partner who is sterile prior to the patient's entry and is the sole sexual partner for that woman.
  • Complete abstinence from sexual intercourse for 14 days before exposure to investigation product, throughout the clinical trial, and for at least 21 days after the last dose of investigational product.
  • Double-barrier contraception defined as condom with spermicidal jelly, foam, suppository, or film; OR male condom and diaphragm.
  • Predicted life expectancy of at least 12 weeks
  • Written informed consent
  • Able to swallow and retain oral medications.

Who cannot join

  • 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.
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  • 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,
  • history of abdominal fistula, GI perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment.
  • Subject must not have psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
  • Subject must not take any specifically prohibited medication specified in the protocol during the study or requires any of these medications during treatment with pazopanib.
  • Subject must not have clinical history, current alcohol or illicit drug use which, in the judgment of the Investigator, would interfere with the patient's ability to comply with the dosing schedule and protocol-specified evaluations.
  • Subject must not be allergic to either TAXOL or PARAPLATIN, or any other taxane or platinum containing compound.
  • Subject must not have a current diagnosis of cervical cancer.
  • Subject must not have known endobronchial metastasis or involvement of large pulmonary vessel(s) by tumor.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • GSK Investigational Site

    Cleveland, Ohio, 44106

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    New Brunswick, New Jersey, 08901

Other trials in United States

About this study

Official title: 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

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.

Being tested
Pazopanib, Lapatinib, paclitaxel, carboplatin
Keywords
carboplatin, lapatinib, TAXOL, PARAPLATIN, paclitaxel, TYKERB, Pazopanib
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PazopanibDrug

    pazopanib in combination with paclitaxel in Part 1, paclitaxel and carboplatin in Part 2, and paclitaxel and lapatinib in Part 3

  • LapatinibDrug

    Lapatinib in combination with pazopanib and paclitaxel in Part 3

  • paclitaxelDrug

    Also called TAXOL

    in combination with pazopanib

  • carboplatinDrug

    Also called PARAPLATIN

    in combination with pazopanib

Study groups in NCT00388076
Study groupRoleWhat they receive
Part 1Experimentalpazopanib and paclitaxel
Receives: Drug: Pazopanib; Drug: paclitaxel
Part 2Experimentalpazopanib, paclitaxel, and carboplatin
Receives: Drug: Pazopanib; Drug: paclitaxel; Drug: carboplatin
Part 3Experimentalpazopanib, paclitaxel, and lapatinib
Receives: Drug: Pazopanib; Drug: Lapatinib; Drug: paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Effects, Laboratory parameters

    Measured: before and after taking the study medications.

Secondary outcomes (2)

  1. Blood samples

    Measured: over a 24 hour period

  2. Tumors

    Measured: will be measured at routine intervals throughout (e.g. by CT scan).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2006 (estimated)
  2. Study start28 Apr 2006
  3. Primary completion21 Jul 2009
  4. Study completion21 Jul 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00388076
Sponsor's protocol ID
VEG105427
Status last verified
Nov 2017
First submitted
11 Oct 2006
Last updated
17 Nov 2017
Results posted
No

Publications

  • 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.

    PubMed 22679111

  • Tan 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.

    PubMed 21147873

  • Tan 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.

    PubMed 24800949

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pazopanib, Lapatinib and paclitaxel in people with Neoplasms, Breast, run by GlaxoSmithKline at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Effects, Laboratory parameters (time frame: before and after taking the study medications.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00388076, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.

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