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Lung CancerPhase 1NCT00324597

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

A Phase 1 study testing gemcitabine hydrochloride, motesanib diphosphate and pharmacological study in people with Lung Cancer and Lymphoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
gemcitabine hydrochloride, motesanib diphosphate and pharmacological study
How many people
18 participants
Where
1 siteUnited States
Study dates
Oct 2005to not given
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095-1781

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
gemcitabine hydrochloride, motesanib diphosphate, pharmacological study
Keywords
unspecified adult solid tumor, protocol specific, recurrent adult grade III lymphomatoid granulomatosis, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage III mantle cell lymphoma, stage IV mantle cell lymphoma, stage III marginal zone lymphoma, stage IV marginal zone lymphoma, stage III small lymphocytic lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, stage III adult T-cell leukemia/lymphoma, recurrent adult Hodgkin lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult T-cell leukemia/lymphoma
Medical subject headings
Lung Neoplasms, Lymphoma, Lymphoproliferative Disorders, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, T-Cell, Cutaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose-limiting toxicity as assessed by NCI CTCAE v3.0

  2. Maximum tolerated dose as assessed by NCI CTCAE v3.0

Secondary outcomes (4)
  1. Pharmacokinetic profiles as measured by blood sampling at weeks 1, 2, 9, 13, 21, 29, 37, 45, and 49

  2. Incidence of adverse events, serious adverse events, and laboratory abnormalities not defined as dose-limiting toxicities as assessed by NCI CTCAE v3.0

  3. Response rate (complete and partial response) as measured by modified RECIST at weeks 12, 24, 36, 48, and 49

  4. Biomarkers as measured by RNA transcript profiling and/or proteomic methods at weeks 1, 2, 4, 9, 13, 21, 29, 37, 45, 49

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2006 (estimated)
  2. Study startOct 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00324597
Sponsor's protocol ID
CDR0000481095
Other IDs
UCLA-0506055-01
Status last verified
Apr 2007
First submitted
10 May 2006
Last updated
17 Sep 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing gemcitabine hydrochloride, motesanib diphosphate and pharmacological study in people with Lung Cancer and Lymphoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose-limiting toxicity as assessed by NCI CTCAE v3.0. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2013.

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