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AMG 706 and Gemcitabine in Treating Patients With Advanced Solid Tumors or Lymphoma

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ClinicalTrials.gov Identifier: NCT00324597
Recruitment Status : Unknown
Verified April 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : May 11, 2006
Last Update Posted : September 17, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE May 10, 2006
First Posted Date  ICMJE May 11, 2006
Last Update Posted Date September 17, 2013
Study Start Date  ICMJE October 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
  • Incidence of dose-limiting toxicity as assessed by NCI CTCAE v3.0
  • Maximum tolerated dose as assessed by NCI CTCAE v3.0
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AMG 706 and Gemcitabine in Treating Patients With Advanced Solid Tumors or Lymphoma
Official Title  ICMJE A Phase Ib, Open-Label, Sequential, Dose-Finding, Study of AMG 706 in Combination With Gemcitabine to Treat Subjects With Solid Tumors
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lung Cancer
  • Lymphoma
  • Lymphoproliferative Disorder
  • Unspecified Adult Solid Tumor, Protocol Specific
Intervention  ICMJE
  • Drug: gemcitabine hydrochloride
  • Drug: motesanib diphosphate
  • Other: pharmacological study
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 8, 2006)
18
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00324597
Other Study ID Numbers  ICMJE CDR0000481095
UCLA-0506055-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Jonsson Comprehensive Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Carolyn Britten, MD Jonsson Comprehensive Cancer Center
PRS Account National Cancer Institute (NCI)
Verification Date April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP