- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00324597
AMG 706 and Gemcitabine in Treating Patients With Advanced Solid Tumors or Lymphoma
A Phase Ib, Open-Label, Sequential, Dose-Finding, Study of AMG 706 in Combination With Gemcitabine to Treat Subjects With Solid Tumors
RATIONALE: AMG 706 may stop the growth of cancer cells by blocking blood flow to the cancer or by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving AMG 706 together with gemcitabine may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of AMG 706 when given together with gemcitabine in treating patients with advanced solid tumors or lymphoma.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and safety of AMG 706 when given in combination with gemcitabine hydrochloride in patients with advanced solid tumors or lymphoma.
Secondary
- Determine the pharmacokinetic profiles of this regimen in these patients.
OUTLINE: This is a multicenter, open-label, dose-escalation study of AMG 706.
Patients receive oral AMG 706 once daily on days 2-56 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43 of course 1. For all subsequent courses, patients receive oral AMG 706 on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of AMG 706 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity.
During the first course of study treatment, patients undergo blood collection periodically for pharmacokinetic analysis.
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: Approximately 18 patients will be accrued for this study.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
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Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center at UCLA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Incidence of dose-limiting toxicity as assessed by NCI CTCAE v3.0
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Maximum tolerated dose as assessed by NCI CTCAE v3.0
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Secondary Outcome Measures
Outcome Measure |
---|
Pharmacokinetic profiles as measured by blood sampling at weeks 1, 2, 9, 13, 21, 29, 37, 45, and 49
|
Incidence of adverse events, serious adverse events, and laboratory abnormalities not defined as dose-limiting toxicities as assessed by NCI CTCAE v3.0
|
Response rate (complete and partial response) as measured by modified RECIST at weeks 12, 24, 36, 48, and 49
|
Biomarkers as measured by RNA transcript profiling and/or proteomic methods at weeks 1, 2, 4, 9, 13, 21, 29, 37, 45, 49
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- recurrent non-small cell lung cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- unspecified adult solid tumor, protocol specific
- large cell lung cancer
- adenocarcinoma of the lung
- stage III adult diffuse large cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult Burkitt lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult Burkitt lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult Burkitt lymphoma
- recurrent adult Hodgkin lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage III small lymphocytic lymphoma
- stage III marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent mantle cell lymphoma
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- stage III cutaneous T-cell non-Hodgkin lymphoma
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- stage III adult lymphoblastic lymphoma
- stage IV adult lymphoblastic lymphoma
- stage III adult T-cell leukemia/lymphoma
- stage IV adult T-cell leukemia/lymphoma
- recurrent adult T-cell leukemia/lymphoma
- angioimmunoblastic T-cell lymphoma
- anaplastic large cell lymphoma
- stage III mycosis fungoides/Sezary syndrome
- stage IV mycosis fungoides/Sezary syndrome
- recurrent mycosis fungoides/Sezary syndrome
- recurrent adult grade III lymphomatoid granulomatosis
- post-transplant lymphoproliferative disorder
- Waldenström macroglobulinemia
- bronchoalveolar cell lung cancer
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lymphoma
- Lung Neoplasms
- Lymphoproliferative Disorders
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protein Kinase Inhibitors
- Gemcitabine
- Imetelstat
- Motesanib diphosphate
Other Study ID Numbers
- CDR0000481095
- UCLA-0506055-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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