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.
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
- Conditions the study is for
- Lung Cancer, Lymphoma, Lymphoproliferative Disorder
- 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
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.
- Conditions
- Lung Cancer, Lymphoma, Lymphoproliferative Disorder, Unspecified Adult Solid Tumor, Protocol Specific
- 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.
motesanib diphosphateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity as assessed by NCI CTCAE v3.0
Maximum tolerated dose as assessed by NCI CTCAE v3.0
Secondary outcomes (4)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2006 (estimated)
- Study startOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Carolyn Britten, MD, Principal investigator, Jonsson Comprehensive Cancer Center
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Open-Label, Sequential, Dose-Finding, Study of AMG 706 in Combination With Gemcitabine to Treat Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT00324597
- Acronym / sponsor ID
- CDR0000481095
- Conditions
- Lung Cancer, Lymphoma, Lymphoproliferative Disorder, Unspecified Adult Solid Tumor, Protocol Specific
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2005
- First posted
- 11 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gemcitabine hydrochloride | Drug | – |
| motesanib diphosphate | Drug | – |
| pharmacological study | Other | – |
Primary outcome
Incidence of dose-limiting toxicity as assessed by NCI CTCAE v3.0
Maximum tolerated dose as assessed by NCI CTCAE v3.0
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn Britten, MD principal investigator
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
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.