Advanced Solid Tumors, Non-small Cell Lung CancerPhase 1RAPNCT01061788
A Trial of AMG 479, Everolimus (RAD001) and Panitumumab in Patients With Advanced Cancer - QUILT-3.007
A Phase 1 study testing AMG 479, Everolimus, Panitumumab in people with Advanced Solid Tumors, Non-small Cell Lung Cancer, run by Jeffrey Clarke at 1 site in United States.
Trial summary
This open-label, non-randomized, dose escalation phase I biomarker trial of the triplet regimen of AMG 479, everolimus, and panitumumab for subjects with refractory advanced solid tumors is designed to assess the safety and tolerability of this combination as well as preliminary efficacy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Advanced Solid Tumors, Non-small Cell Lung Cancer
- What is being tested?
- AMG 479, Everolimus, Panitumumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to 19 Dec 2018
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically and/or cytologically confirmed malignant solid tumor that is refractory to standard therapies, or for which no standard therapies exist. Disease must be measurable by RECIST criteria.
- For the NSCLC expanded cohort only: Only histologically proven adenocarcinoma that is refractory to standard therapies.
- Age >18 years.
- Karnofsky Performance Status of 60-100.
- Life expectancy of at least 3 months.
- Subjects must have adequate organ and marrow function as defined below:
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- Absolute neutrophil count >/=1,500/μl
- Platelets >/=100,000/μl
- Magnesium >/= 1.8 mg/dL
- Phosphorus >/= 2.3 mg/dL
- Total bilirubin </= 1.5 X upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) </=2.5 X ULN, </=5 X ULN if known hepatic metastases
- PT/INR; PTT </= 1.3; <1.3 X ULN
- Creatinine clearance >/=40 mL/min/m2 by Cockroft-Gault or MDRD equation
- Hemoglobin >9 g/dL
- Continuation of erythropoietin products is permitted. Hemoglobin must be stable above 9 g/dL for at least 2 weeks without blood transfusion to maintain hemoglobin level.
- Fasting blood sugar </= 160 mg/dL
- Patient may be on diabetic medication to achieve glucose control:
- Documented fasting blood sugars </= 160 mg/dL
- Diabetic subjects who have recently had their glycemic control regimens adjusted and have documented fasting blood glucose concentrations ≤ 160 mg/dL may be considered regardless of HgbA1c value, if per investigator discretion the subject is considered to have adequate glycemic function
- Ability to understand and the willingness to sign a written informed consent document.
- NSCLS expanded cohort only: Total of 20 never smokers and non-smokers. Never smokers are defined as individuals who have never smoked and non-smokers are defined as individuals with a ≤10 pack year history and have quit >15 years
Who cannot join
- Radiation therapy, hormonal therapy, biologic therapy or chemotherapy for cancer within the 28 days prior to day 1 of study drug.
- For the NSCLC expanded cohort only: Palliative radiation therapy ≤14 days of day 1 of study drug.
- Active CNS metastases. MRI (or CT) required within 3 months of starting treatment for all tumor types known to commonly metastasize to the brain (i.e. all tumors except pancreas, colorectal, ovarian) and for all patients with CNS symptoms that may represent CNS metastases. Metastases which have been treated with radiotherapy > 2 months prior to start of protocol therapy and are asymptomatic (off steroid therapy for at least 1 month) may be included. Patients must have had normal or stable (if treated, no new lesions) brain imaging (CT or MRI) within the two months prior to day 1 of study drug.
- For the NSCLC expanded cohort only: Radiation ≤ 14 days prior to day 1 of study drug. Subjects must be off steroids for > 14 days prior to day 1 of study drug and anticonvulsants must be discontinued.
- Inadequately controlled hypertension (defined as systolic blood pressure 140 and/or diastolic blood pressure > 90 mmHg). Initiation of antihypertensive is permitted provided adequate control is documented over at least 1 week prior to day 1 of study drug.
- Evidence of active bleeding diathesis or coagulopathy. For the NSCLC expanded cohort only: History of "blood tinged" sputum allowed.
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- No warfarin therapy. Low molecular weight heparin anticoagulation is permitted provided that patients have been clinically stable on anti-coagulation for at least 2 weeks prior to day 1 of study drug and meet platelet inclusion criteria. No history of active GI bleeding or other major bleeding within previous 6 months prior to day 1 of study drug.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 of study drug (56 days for hepatectomy, open thoracotomy, major neurosurgery) or anticipation of need for major surgical procedure during the course of the study.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 1 of study drug.
- Serious, non-healing wound, ulcer, or bone fracture.
- Any prior history of hypertensive crisis or hypertensive encephalopathy.
- New York Heart Association (NYHA) Grade II or greater congestive heart failure.
- History of clinically significant vascular disease, including any of the following within 6 months prior to day 1 of study drug: myocardial infarction or unstable angina, percutaneous coronary intervention, bypass grafting, ventricular arrhythmia requiring medication, stroke or transient ischemic attack, symptomatic peripheral arterial disease and/or involvement of great vessels by tumor with or without vascular grafting.
- Chronic treatment with systemic steroids or another immunosuppressive agent with the following exceptions:
- Intermittent steroids may be used on an as-needed basis (e.g. treatment for chemotherapy-related nausea.) Patients on physiologic replacement doses of steroids due to adrenal insufficiency for any reason may remain on these medications.
- A known history of HIV seropositivity, hepatitis C virus, acute or chronic active hepatitis B infection, or other serious chronic infection requiring ongoing treatment.
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption (e.g. inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or significant small bowel resection).
- Patient unwilling to or unable to comply with the protocol.
- Medical need for the continuous administration of any drugs which affect CYP3A4 though the use of low dose glucocorticoids (e.g. Dexamethasone </= 4 mg daily or equivalent) for anorexia and /or nausea is permitted.
- History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis, or any evidence of interstitial lung disease on baseline chest CT scan.
- For the NSCLC expanded cohort only: Scarring from previous radiation therapy or pneumonia allowed.
- Patients who are pregnant and/or lactating are excluded from this study. (The effect of the investigational drugs on the developing human fetus is not known, but these drugs are likely to be embryo- and feto-toxic. Women of child-bearing potential and men must agree to use two forms of adequate contraception (hormonal or barrier method of birth control; abstinence) prior to day 1 of study drug, the duration of study participation and 6 months after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner are participating in this study, she should inform her treating physician and study PI immediately. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. )
- Other concurrent severe and/or uncontrolled medical, psychiatric or social conditions that could compromise the safety or compliance of treatment as so judged by treating physician. Examples include but are not limited to:
- History of severely impaired lung function defined as spirometry and DLCO that is </= 50% of the normal predicted value and/or 02 saturation that is </= 88% at rest on room air.
- Uncontrolled diabetes mellitus consistent fasting blood glucose readings > 160 mg/dL or < 50 mg/dL). Use of diabetic medications is permitted.
- Hyperlipidemia (>CTC Grade 2: Total Cholesterol > 300-400; Triglycerides > 2.5 ULN). Use of lipid lowering agents is permitted.
- Other: e.g. severe infection, severe malnutrition, ventricular arrhythmias, known active vasculitis of any cause, tumor invasion of any major blood vessel, severe chronic liver or renal disease, active upper GI tract ulceration.
- No immunizations with attenuated live vaccines within one week of study entry or during study period.
- 21 Proteinuria at screening as demonstrated by either urine protein: creatinine (UPC) ratio greater than or equal to 1.0 or 24hr collection greater than 1g/24hr at screening.
- 22 NSCLC cohort only: Current smoker
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: A Phase I Trial of the IGF-1R Antibody AMG 479 in Combination With Everolimus (RAD001) and Panitumumab in Patients With Advanced Cancer (The RAP Trial)
This open-label, non-randomized, dose escalation phase I biomarker trial of the triplet regimen of AMG 479, everolimus, and panitumumab for subjects with refractory advanced solid tumors is designed to assess the safety and tolerability of this combination as well as preliminary efficacy.
Read the detailed description
The purpose of this study is to find the safest dose of the drugs AMG 479 and everolimus in combination and then with panitumumab added. This study will consist of two parts. If you are enrolled in Part One of the study, you will receive AMG 479 and everolimus. If you are enrolled in Part Two of the study, you will receive AMG 479, everolimus, and panitumumab. The study will also look at how the drugs work in the body, and will see if there is any effect on your cancer.
The study will have two parts: The first part will be to define the MTD/RPTD of the doublet combination of AMG 479 + everolimus using a standard 3-6 subjects per dose level. Since each agent is known to be well tolerated as monotherapy, we will start with the full dose of AMG 479 and escalate the dose of everolimus. Once the RPTD is established, an additional 20 subjects will be added to confirm the tolerability of this regimen and to allow more detailed biomarker assessment for the effect of each agent alone in the doublet combination. In this biomarker expanded cohort, subjects will start treatment with 2 weeks of AMG 479 monotherapy (a single dose of AMG 479), followed by the combination of AMG 479 + everolimus on day 15.
The second part of the study will assess tolerability of the triplet therapy, with panitumumab added to the RPTD of AMG 479 + everolimus, again using a standard cohort size of 3-6 subjects. Finally, at the recommended phase II dose of the triplet therapy, 20 subjects will be added to an expanded safety and biomarker cohort. In this biomarker expanded cohort, 10 subjects will start treatment with two weeks of AMG 479 monotherapy (a single dose of AMG 479), and 10 subjects will start treatment with two weeks of everolimus monotherapy, with all subjects starting the triplet combination therapy with panitumumab on day 15.
Two sustained complete responses (one > 2 years of complete response, second >8 months of complete response) were seen in subjects with refractory NSCLC (never smokers) enrolled in the doublet regimen. Therefore, an additional 20 subjects with NSCLC, never smokers or non-smokers with ≤ 10 year pack smoking history will be enrolled at MTD/RPTD to further assess safety, tolerability and clinical activity in this specific patient cohort. In this cohort, subjects will start both drugs on cycle 1, day 1.
ABOUT THE STUDY DRUGS:
AMG 479 is an intravenous (I.V., meaning through a vein) medication made from a special type of human protein called antibodies. AMG 479 blocks the activity of another protein called IGF-1R which is important for tumors to grow. Blocking IGFR-1 activity has been shown to slow or kill cancer cells in laboratory studies. AMG 479 is currently being evaluated in clinical research studies in a variety of cancers. AMG 479 is not approved by the U.S. Food and Drug Administration (FDA) for the treatment of cancer and is therefore considered an investigational drug.
Everolimus is a pill that works by blocking the activity of a substance in the body known as mTOR (mammalian target of rapamycin). mTOR is important for helping the growth and survival in normal and cancer cells. Blocking mTOR activity has been shown to slow or kill cancer cells in laboratory studies. Everolimus is currently being evaluated in clinical research studies in a variety of cancers. Everolimus (AfinitorTM) is approved by the FDA for the treatment of advanced renal cell carcinoma (kidney cancer), subependymal giant cell astrocytoma (a type of brain cancer), neuroendocrine tumors originating in the lung or gastrointestinal (GI) tract, and HER2-negative breast cancer. Besides cancer, everolimus also has been tested for its ability to help block the rejection of solid organs transplants (such as liver or kidney transplants). Everolimus is approved for this purpose in Europe but not in the United States.
Panitumumab is another intravenous (I.V.) medication made from a special type of human protein called antibodies. Panitumumab blocks the activity of a protein called EGFr which is also important for tumors to grow. Blocking EGFr activity has been shown to slow or kill cancer cells in laboratory studies. Panitumumab is currently being evaluated in clinical research studies in a variety of cancers. Panitumumab (Vectibix™) is approved by the FDA for the treatment of advanced colorectal cancer following 5'FU, oxaliplatin and irinotecan chemotherapy regimens.
- Being tested
- AMG 479, Everolimus, Panitumumab
- Keywords
- Phase I, Solid Tumor, AMG 479, Panitumumab, Everolimus, RAD001, Duke, Subjects with refractory advanced solid tumors, non-small cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 479, Everolimus, PanitumumabDrug
Dose Escalation Cohort #, Subjects, Everolimus, AMG 479
- 3-6 subjects, Study drug administered per dose level
- 3-6 subjects, Study drug administered per dose level Expanded Cohort Subjects, Everolimus, AMG 479 20 subjects, study drug administered per dose level Dose Escalation, Cohort #, Subjects, Everolimus, AMG 479, Panitumumab
- 3-6 subjects, Study drug administered per dose level
- 3-6 subjects, Study drug administered per dose level
Expanded Cohort Subjects, Everolimus, AMG 479, Panitumumab 20 subjects, Study drug administered per dose level
NSCLS Cohort Subjects, Everolimus, AMG 479, 20 subjects, Study drug administered per dose level
| Study group | Role | What they receive |
|---|---|---|
| Everolimus, AMG 479, Panitumumab | Experimental | Dose Escalation Cohort #, Subjects, Everolimus, AMG 479
1. 3-6 subjects, Study drug administered per dose level
2. 3-6 subjects, Study drug administered per dose level
Expanded Cohort Subjects, Everolimus, AMG 479 20 subjects, study drug administered per dose level
Dose Escalation, Cohort #, Subjects, Everolimus, AMG 479, Panitumumab
3. 3-6 subjects, Study drug administered per dose level
4. 3-6 subjects, Study drug administered per dose level
Expanded Cohort Subjects, Everolimus, AMG 479, Panitumumab 20 subjects, Study drug administered per dose level
NSCLC Cohort Subjects, Everolimus, AMG 479, 20 subjects, Study drug administered per dose level Receives: Drug: AMG 479, Everolimus, Panitumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define the maximal tolerated dose (MTD) and/or recommended phase II dose (RPTD) for the doublet AMG 479 in combination with everolimus in subjects with advanced solid tumors.
Measured: 3 years
To define the maximal tolerated dose (MTD) and/or recommended phase II dose (RPTD) for the triplet AMG 479 in combination with everolimus and panitumumab in subjects with advanced solid tumors.
Measured: 3 years
Secondary outcomes (2)
To describe the toxicity profile seen with these combinations.
Measured: 3 years
To describe any signs of clinical activity, including response rate and progression free survival associated with these regimens.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startApr 2010
- Primary completion19 Dec 2018
- Study completion19 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumors, Non-small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeffrey Clarke
- Sponsor type
- University, hospital or other
- Collaborators
- NantCell, Inc., Novartis Pharmaceuticals
- Responsible party
- Sponsor-investigator, Jeffrey Clarke, Duke University
- Investigators
- Herbert Hurwitz, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061788
- Sponsor's protocol ID
- Pro00021317
- Acronym
- RAP
- Status last verified
- Aug 2019
- First submitted
- 2 Feb 2010
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of the IGF-1R Antibody AMG 479 in Combination With Everolimus (RAD001) and Panitumumab in Patients With Advanced Cancer (The RAP Trial)
- ClinicalTrials.gov ID
- NCT01061788
- Acronym / sponsor ID
- RAP / Pro00021317
- Keywords
- Phase I, Solid Tumor, AMG 479, Panitumumab, Everolimus, RAD001, Duke, Subjects with refractory advanced solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Jeffrey ClarkeUniversity, hospital or other
- Collaborators
- NantCell, Inc., Novartis Pharmaceuticals
- Study start
- Apr 2010
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 19 Dec 2018 (actual)
- First posted
- 3 Feb 2010 (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.
This open-label, non-randomized, dose escalation phase I biomarker trial of the triplet regimen of AMG 479, everolimus, and panitumumab for subjects with refractory advanced solid tumors is designed to assess the safety and tolerability of this combination as well as preliminary efficacy.
Detailed description
The purpose of this study is to find the safest dose of the drugs AMG 479 and everolimus in combination and then with panitumumab added. This study will consist of two parts. If you are enrolled in Part One of the study, you will receive AMG 479 and everolimus. If you are enrolled in Part Two of the study, you will receive AMG 479, everolimus, and panitumumab. The study will also look at how the drugs work in the body, and will see if there is any effect on your cancer.
The study will have two parts: The first part will be to define the MTD/RPTD of the doublet combination of AMG 479 + everolimus using a standard 3-6 subjects per dose level. Since each agent is known to be well tolerated as monotherapy, we will start with the full dose of AMG 479 and escalate the dose of everolimus. Once the RPTD is established, an additional 20 subjects will be added to confirm the tolerability of this regimen and to allow more detailed biomarker assessment for the effect of each agent alone in the doublet combination. In this biomarker expanded cohort, subjects will start treatment with 2 weeks of AMG 479 monotherapy (a single dose of AMG 479), followed by the combination of AMG 479 + everolimus on day 15.
The second part of the study will assess tolerability of the triplet therapy, with panitumumab added to the RPTD of AMG 479 + everolimus, again using a standard cohort size of 3-6 subjects. Finally, at the recommended phase II dose of the triplet therapy, 20 subjects will be added to an expanded safety and biomarker cohort. In this biomarker expanded cohort, 10 subjects will start treatment with two weeks of AMG 479 monotherapy (a single dose of AMG 479), and 10 subjects will start treatment with two weeks of everolimus monotherapy, with all subjects starting the triplet combination therapy with panitumumab on day 15.
Two sustained complete responses (one > 2 years of complete response, second >8 months of complete response) were seen in subjects with refractory NSCLC (never smokers) enrolled in the doublet regimen. Therefore, an additional 20 subjects with NSCLC, never smokers or non-smokers with ≤ 10 year pack smoking history will be enrolled at MTD/RPTD to further assess safety, tolerability and clinical activity in this specific patient cohort. In this cohort, subjects will start both drugs on cycle 1, day 1.
ABOUT THE STUDY DRUGS:
AMG 479 is an intravenous (I.V., meaning through a vein) medication made from a special type of human protein called antibodies. AMG 479 blocks the activity of another protein called IGF-1R which is important for tumors to grow. Blocking IGFR-1 activity has been shown to slow or kill cancer cells in laboratory studies. AMG 479 is currently being evaluated in clinical research studies in a variety of cancers. AMG 479 is not approved by the U.S. Food and Drug Administration (FDA) for the treatment of cancer and is therefore considered an investigational drug.
Everolimus is a pill that works by blocking the activity of a substance in the body known as mTOR (mammalian target of rapamycin). mTOR is important for helping the growth and survival in normal and cancer cells. Blocking mTOR activity has been shown to slow or kill cancer cells in laboratory studies. Everolimus is currently being evaluated in clinical research studies in a variety of cancers. Everolimus (AfinitorTM) is approved by the FDA for the treatment of advanced renal cell carcinoma (kidney cancer), subependymal giant cell astrocytoma (a type of brain cancer), neuroendocrine tumors originating in the lung or gastrointestinal (GI) tract, and HER2-negative breast cancer. Besides cancer, everolimus also has been tested for its ability to help block the rejection of solid organs transplants (such as liver or kidney transplants). Everolimus is approved for this purpose in Europe but not in the United States.
Panitumumab is another intravenous (I.V.) medication made from a special type of human protein called antibodies. Panitumumab blocks the activity of a protein called EGFr which is also important for tumors to grow. Blocking EGFr activity has been shown to slow or kill cancer cells in laboratory studies. Panitumumab is currently being evaluated in clinical research studies in a variety of cancers. Panitumumab (Vectibix™) is approved by the FDA for the treatment of advanced colorectal cancer following 5'FU, oxaliplatin and irinotecan chemotherapy regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Everolimus, AMG 479, Panitumumab | Experimental | Drug: AMG 479, Everolimus, PanitumumabDose Escalation Cohort #, Subjects, Everolimus, AMG 479 1. 3-6 subjects, Study drug administered per dose level 2. 3-6 subjects, Study drug administered per dose level Expanded Cohort Subjects, Everolimus, AMG 479 20 subjects, study drug administered per dose level Dose Escalation, Cohort #, Subjects, Everolimus, AMG 479, Panitumumab 3. 3-6 subjects, Study drug administered per dose level 4. 3-6 subjects, Study drug administered per dose level Expanded Cohort Subjects, Everolimus, AMG 479, Panitumumab 20 subjects, Study drug administered per dose level NSCLC Cohort Subjects, Everolimus, AMG 479, 20 subjects, Study drug administered per dose level |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Histologically and/or cytologically confirmed malignant solid tumor that is refractory to standard therapies, or for which no standard therapies exist. Disease must be measurable by RECIST criteria.
- For the NSCLC expanded cohort only: Only histologically proven adenocarcinoma that is refractory to standard therapies.
- Age >18 years.
- Karnofsky Performance Status of 60-100.
- Life expectancy of at least 3 months.
Key exclusion criteria (30 listed)
- Radiation therapy, hormonal therapy, biologic therapy or chemotherapy for cancer within the 28 days prior to day 1 of study drug.
- For the NSCLC expanded cohort only: Palliative radiation therapy ≤14 days of day 1 of study drug.
- Active CNS metastases. MRI (or CT) required within 3 months of starting treatment for all tumor types known to commonly metastasize to the brain (i.e. all tumors except pancreas, colorectal, ovarian) and for all patients with CNS symptoms that may represent CNS metastases. Metastases which have been treated with radiotherapy > 2 months prior to start of protocol therapy and are asymptomatic (off steroid therapy for at least 1 month) may be included. Patients must have had normal or stable (if treated, no new lesions) brain imaging (CT or MRI) within the two months prior to day 1 of study drug.
- For the NSCLC expanded cohort only: Radiation ≤ 14 days prior to day 1 of study drug. Subjects must be off steroids for > 14 days prior to day 1 of study drug and anticonvulsants must be discontinued.
- Inadequately controlled hypertension (defined as systolic blood pressure 140 and/or diastolic blood pressure > 90 mmHg). Initiation of antihypertensive is permitted provided adequate control is documented over at least 1 week prior to day 1 of study drug.
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 |
|---|---|---|
| AMG 479, Everolimus, PanitumumabDose Escalation Cohort #, Subjects, Everolimus, AMG 479 1. 3-6 subjects, Study drug administered per dose level 2. 3-6 subjects, Study drug administered per dose level Expanded Cohort Subjects, Everolimus, AMG 479 20 subjects, study drug administered per dose level Dose Escalation, Cohort #, Subjects, Everolimus, AMG 479, Panitumumab 3. 3-6 subjects, Study drug administered per dose level 4. 3-6 subjects, Study drug administered per dose level Expanded Cohort Subjects, Everolimus, AMG 479, Panitumumab 20 subjects, Study drug administered per dose level NSCLS Cohort Subjects, Everolimus, AMG 479, 20 subjects, Study drug administered per dose level | Drug | Everolimus, AMG 479, Panitumumab |
Primary outcome
To define the maximal tolerated dose (MTD) and/or recommended phase II dose (RPTD) for the doublet AMG 479 in combination with everolimus in subjects with advanced solid tumors.
Time frame: 3 years
To define the maximal tolerated dose (MTD) and/or recommended phase II dose (RPTD) for the triplet AMG 479 in combination with everolimus and panitumumab in subjects with advanced solid tumors.
Time frame: 3 years
2 secondary outcomes
To describe the toxicity profile seen with these combinations.
Time frame: 3 years
To describe any signs of clinical activity, including response rate and progression free survival associated with these regimens.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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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.
Herbert Hurwitz, MD principal investigator
Duke University
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 AMG 479, Everolimus, Panitumumab in people with Advanced Solid Tumors, Non-small Cell Lung Cancer, run by Jeffrey Clarke 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?
The sponsor lists 22 inclusion and 30 exclusion criteria. 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: finished, as of the sponsor's last update on 28 Aug 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To define the maximal tolerated dose (MTD) and/or recommended phase II dose (RPTD) for the doublet AMG 479 in combination with everolimus in subjects with advanced solid tumors. (time frame: 3 years). 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 28 Aug 2019.