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A Randomized, Open-label, Phase II, 2-arm Multi-center Trial Comparing Maintenance Therapy With Pazopanib or Pemetrexed in Non-progressing Subjects With Metastatic Stage IVA and IVB Non-squamous Non-small Cell Lung Cancer (NSCLC) After Induction Therapy With Carboplatin + Pemetrexed or Cisplatin + Pemetrexed


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer, Small Cell

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Trial Information

A Randomized, Open-label, Phase II, 2-arm Multi-center Trial Comparing Maintenance Therapy With Pazopanib or Pemetrexed in Non-progressing Subjects With Metastatic Stage IVA and IVB Non-squamous Non-small Cell Lung Cancer (NSCLC) After Induction Therapy With Carboplatin + Pemetrexed or Cisplatin + Pemetrexed


Inclusion Criteria:



- Signed written Informed Consent.

- Subjects must complete 4 to 6 cycles of chemotherapy with carboplatin + pemetrexed or
cisplatin + pemetrexed and have had SD, PR or CR at the time of screening/enrolment
as the best response.

- Prior surgery and/or localized irradiation for NSCLC is permitted as long as it was a
minimum of 4 weeks before entering the study. Subjects with recurrence after
previous NSCLC that has been treated with surgery and adjuvant chemotherapy or a
radio-chemotherapy regimen with curative intent are eligible, provided 1 year has
passed since this treatment ended.

- Histologically or cytologically confirmed diagnosis of predominantly non-squamous
cell Stage IVA Wet (with cytology positive Malignant Pleural Effusion (MPE)) or Stage
IVB (metastatic) NSCLC.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Life expectancy of at least 12 weeks.

- Must have measurable disease per Response Evaluation Criteria In Solid Tumors
(RECIST). A measurable lesion is defined as a lesion that can be accurately measured
in at least one dimension with the longest diameter ≥ 20 mm using conventional
techniques, or ≥ 10 mm with spiral computed tomography (CT) scan.

- Able to swallow and retain oral medication.

- Adequate organ system function.

- Women of childbearing potential must have a negative pregnancy test within <= 7 days
prior to administration or dispensing of study treatment and agree to use effective
contraception.

- Age ≥ 18 years of legal age of consent if different from 18 years.

Exclusion Criteria:

- History of active or any other malignancy other than lung cancer in the 2 yrs prior
to the first dose of study drug other than NSCLC. Exception: Subjects with a history
of completely resected non-melanomatous skin carcinoma or successfully treated in
situ carcinoma are eligible.

- History or clinical evidence of central nervous system (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 medications for 4 months prior to first dose of study drug. Screening with
CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is
required only if clinically indicated or if the subject has a history of CNS
metastases.

- Clinically significant gastrointestinal abnormalities that may increase the risk for
gastrointestinal bleeding including, but not limited to:

- Active peptic ulcer disease

- Known intraluminal metastatic lesion/s with risk of bleeding

- Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or other
gastrointestinal conditions with increased risk of perforation

- History of abdominal fistula, gastrointestinal perforation, or intra abdominal
abscess within 28 days prior to beginning study treatment

- Clinically significant gastrointestinal abnormalities that may affect absorption of
investigational product including, but not limited to:

Malabsorption syndrome Major resection of the stomach or small bowel

- Presence of uncontrolled infection.

- Corrected QT interval (QTc) > 480 msecs using Bazett's formula

- History of any one or more of the following cardiovascular conditions within the past
6 months:

Cardiac angioplasty or stenting Myocardial infarction Unstable angina Coronary artery
bypass graft surgery Symptomatic peripheral vascular disease Class III or IV congestive
heart failure, as defined by the New York Heart Association (NYHA).

- Poorly controlled hypertension, defined as systolic blood pressure (SBP) of ≥140 mmHg
or diastolic blood pressure (DBP) of

- 90mmHg.

Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to
study entry. Blood pressure (BP) must be re-assessed on two occasions that are separated
by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP
values from each BP assessment must be <140/90 mmHg in order for a subject to be eligible
for the study.

- History of cerebrovascular accident including transient ischemic attack (TIA),
pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6
months. Note: Subjects with recent DVT who have been treated with therapeutic anti-
coagulating agents for at least 6 weeks are eligible.

- Prior major surgery or trauma within 28 days prior to first dose of study drug and/or
presence of any non-healing wound, fracture, or ulcer (procedures such as catheter
placement not considered to be major).

- Evidence of active bleeding or bleeding diathesis.

- Recent hemoptysis (>=½ teaspoon of red blood within 8 weeks before first dose of
study drug).

- Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
(Note: tumor abutting the vessel is acceptable, but contiguous tumor and vessel is
not; CT with contrast is strongly recommended to evaluate such lesions).

- Any serious and/or unstable pre-existing medical, psychiatric, or other condition
that would make the subject inappropriate for study participation including any
serious condition that could interfere with subject's safety, provision of informed
consent, or compliance to study procedures.

- Use of any prohibited medication within the timeframes listed in the protocol.

- Prior use of an investigational agent within 28 days or 5 half-lives, whichever is
longer, prior the first dose of study drug.

- Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 (except the
value for hemoglobin; see Table 1) and/or that is progressing in severity, except
alopecia.

- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
chemically related to pazopanib and/or pemetrexed.

- Inability to interrupt aspirin or other non-steroidal anti-inflammatory drugs
(NSAIDs) 2 days before, the day of, and 2 days after the dose of pemetrexed. If a
subject is taking an NSAID (COX-2 inhibitors included) or salicylate with a long
half-life (e.g.

naproxen, piroxicam, diflusinal, nabumetone, rofecoxib, or celecoxib) it should not be
taken 5 days before, the day of, and 2 days after the dose of pemetrexed.

- Inability or unwillingness to take folic acid, vitamin B12 supplementation, or
dexamethasone.

- Have clinically significant third-space fluid collections (e.g., ascites or pleural
effusions) that cannot be controlled by drainage or other procedures prior to Day 1,
Cycle 1.

- Treatment with any of the following anti-cancer therapies:

radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of
pazopanib OR chemotherapy, immunotherapy, biologic therapy, investigational therapy or
hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior
to the first dose of pazopanib

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Description:

PFS is defined as the interval between the date of randomization and the first documented sign of investigator-assessed (per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) disease progression (PD) or death, whichever occurs first. The date of documented PD is the date of lesion evaluation in the case of radiological PD and the date of symptomatic cancer progression in the case of symptomatic progression (radiological confirmation is required). PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. If the participant received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS was to be censored at the last adequate assessment (LAA) prior to the initiation of therapy. Otherwise, if the participant did not have a documented date of progression or death, PFS was to be censored at the date of the LAA.

Outcome Time Frame:

From randomization until the first documented sign of investigator-assessed disease progression or death, whichever occurred first (average of 10 study weeks)

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

113758

NCT ID:

NCT01313663

Start Date:

February 2011

Completion Date:

July 2012

Related Keywords:

  • Lung Cancer, Small Cell
  • NSCLC
  • pemetrexed
  • pazopanib
  • GW786034
  • non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteNew York, New York  10021