Clinical trial NCT00678977 (phase 1, status: completed)
Conditions: lung cancer, non-small cell
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: pazopanib (gw786034), gemcitabine, cisplatin
SMILES: CN(C1=CC2=NN(C)C(C)=C2C=C1)C1=CC=NC(NC2=CC=C(C)C(=C2)S(N)(=O)=O)=N1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC
Eligibility criteria:

        Inclusion Criteria:

          -  Patients should have a histologically or cytologically confirmed advanced solid tumor,
             having failed standard therapy or for whom there is no standard therapy. Patients
             should have unresectable or metastatic disease.

          -  Age greater than or equal to 18 years

          -  Performance status must be ECOG 0-1.

          -  Prior therapies allowed: unlimited.

          -  Adequate organ function

          -  Patients must have measurable or evaluable disease:

          -  No unstable or serious concurrent condition.

          -  A female subject is eligible to enter and participate in the study if she is: Of
             non-childbearing potential

          -  Subjects must discontinue HRT prior to study enrolment due to the inhibition of CYP
             enzymes that metabolize estrogens and progestins.

          -  Childbearing potential, includes any female who has had a negative serum pregnancy
             test at screening and within 2 weeks prior to the first dose of study treatment,
             preferably as close to the first dose as possible, and agrees to use adequate
             contraception.

          -  A male with a female partner of childbearing potential is eligible to enter and
             participate in the study if he uses a barrier method of contraception or abstinence
             during the study.

          -  Patients must provide written informed consent prior to performance of study specific
             procedures or assessments, and must be willing to comply with treatment and follow up

          -  At least 4 weeks must have elapsed since last administration of chemotherapy and
             subjects must have recovered from any toxicity attributed to the agent prior to
             enrolment in this study.

          -  Prior radiotherapy is permissible, provided at least 4 weeks have elapsed since the
             last treatment to allow for full bone marrow recovery.

          -  Patients with metastatic disease to the brain should have definitive therapy for their
             brain metastases, should be asymptomatic. (Patients with previously treated brain
             metastases who are asymptomatic, off steroids and anti-seizure medications for greater
             than 3 months are eligible for study.)

        Exclusion Criteria:

          -  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
             medication for one week prior to first dose of study drug. Screening with CNS imaging
             studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required.

          -  Clinically significant gastrointestinal abnormalities which might interfere with oral
             dosing

          -  Presence of uncontrolled infection

          -  Prolongation of corrected QT interval (QTc) > 480 msecs.

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

        Cardiac angioplasty or stenting; myocardial infarction; unstable angina; symptomatic
        peripheral vascular disease; Class III or IV congestive heart failure as defined by the New
        York Heart Association

          -  Has had any major surgery, chemotherapy, investigational agent, biological therapy or
             hormonal therapy within the last 28 days and/or not recovered from a prior therapy.

          -  Any unstable or serious concurrent condition (e.g., active infection requiring
             systemic therapy)

          -  Poorly controlled hypertension [defined as systolic blood pressure (SBP) of greater
             than or equal to 140mmHg or diastolic blood pressure (DBP) of greater than or equal to
             90mmHg].

          -  History of cerebrovascular accident (CVA), pulmonary embolism or untreated deep venous
             thrombosis (DVT) within the past 6 months.

          -  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.

          -  Evidence of active bleeding or bleeding diathesis.

          -  Hemoptysis within 6 weeks prior to first dose of study drug.

          -  Any serious and/or unstable pre-existing medical, psychiatric, or other condition that
             could interfere with patient's safety, provision of informed consent, or compliance to
             study procedures.

          -  Is unable or unwilling to discontinue prohibited medications, as listed in Section 8.2
             for 14 days or five half-lives of a drug prior to Visit 1 and for the duration of the
             study.

          -  Use of an investigational agent, including an investigational anti-cancer agent,
             within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study
             drug.

          -  Prior use of an investigational or licensed tyrosine kinase inhibitor that targets
             VEGF receptors.

        Note: Prior use of bevacizumab is allowed.

          -  Is now undergoing and/or has undergone in the 14 days immediately prior to first dose
             of study drug, any cancer therapy (surgery, tumor embolization, chemotherapy,
             radiation therapy, immunotherapy, biological therapy, or hormonal therapy).

        Note: For prior bevacizumab therapy at least 40 days should have elapsed since last dose.

          -  Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is
             progressing in severity.

          -  Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
             chemically related to pazopanib, gemcitabine, or cisplatin. (To date there are no
             known FDA approved drugs chemically related to pazopanib).