A Phase Ib, Open-Label, Sequential, Dose-Finding, Study of AMG 706 in Combination With Gemcitabine to Treat Subjects With Solid Tumors

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed advanced solid tumors or lymphoma

- Must have measurable disease outside a previously irradiated field OR regrowth of
tumor within a previously irradiated field

- Must be a candidate for gemcitabine hydrochloride treatment, in the opinion of the
investigator

- No untreated or symptomatic brain metastases

- No tumors with direct bowel invasion

- No other hematological malignancies

- No non-small cell lung cancer of squamous cell histology or large central tumor
(lesions ≥ 3 cm and located adjacent to or within the hilum or mediastinum)

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Not pregnant

- No nursing during and for 6 months after completion of study treatment

- Fertile patients must use effective contraception during and for 6 months after
completion of study treatment

- Negative pregnancy test

- Able to swallow oral medication

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL

- Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 40 mL/min

- Albumin-adjusted calcium ≥ 8 mg/dL

- Urine protein < 30 mg/dL by urinalysis or < 1+ by dipstick OR < 500 mg by 24-hour
urine collection

- AST or ALT ≤ 2.5 times upper limit of normal (ULN) (5.0 times ULN in the presence of
liver metastasis or primary hepatic neoplasm)

- Bilirubin ≤ 2 times ULN

- PT ≤ 2.0

- INR or PTT ≤ 1.5 times ULN

- Systolic blood pressure (BP) ≤ 145 mm Hg and diastolic BP ≤ 85 mm Hg (stable
antihypertensive medication allowed)

- No myocardial infraction within the past year

- No arterial thrombosis or deep vein thrombosis within the past year

- No unstable angina

- No congestive heart failure

- No New York Heart Association class III-IV cardiac disease

- No other unstable or uncontrolled disease or condition relating to or impacting
cardiac function

- No HIV positivity

- No other condition that would preclude study participation, compliance, or follow-up
assessments

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior enrollment into this study

- At least 1 month since prior investigational device or drug trial

- At least 1 month since prior major surgical procedure

- At least 3 weeks since prior systemic chemotherapy

- At least 2 weeks since prior radiotherapy

- At least 2 weeks since prior rifampin or phenobarbital

- At least 1 week since prior treatment with any of the following:

- Ketoconazole

- Itraconazole

- Clarithromycin

- Erythromycin

- Cyclosporine or tacrolimus

- Nefazodone

- Herbal medications containing Hypericum perforatum (St. John's wort)

- At least 1 week since prior and no concurrent warfarin

- Concurrent prophylactic anticoagulation therapy (e.g., low-dose warfarin [≤ 2
mg/day] or low molecular weight heparin) for venous or arterial access devices
allowed

- No prior or concurrent kinase insert domain-receptor inhibitors

- No concurrent chemotherapy, radiotherapy, hormone-directed cancer therapy, or
tumor-directed antibody therapy

- Gonadotropin releasing-hormone agonist therapy allowed

- No concurrent interferon

- No concurrent grapefruit juice or whole grapefruit

- No other concurrent standard or investigational drugs or antitumor treatment,
including c-kit, platelet-derived growth factor, vascular endothelial growth factor,
or epidermal growth factor inhibitors

- No elective surgery during or for 2 weeks after completion of the last dose of AMG
706