Advanced CarcinomaPhase 1/2NCT00794417
A Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Participants With Advanced Carcinoma
A Phase 1/2 study testing Aflibercept, Pemetrexed and Cisplatin in people with Advanced Carcinoma and Non-small Cell Lung Cancer, run by Regeneron Pharmaceuticals at 15 sites in 2 countries.
Trial summary
The purpose of the study was to determine whether the combination of aflibercept, pemetrexed and cisplatin is safe and effective in treating non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Carcinoma, Non-small Cell Lung Cancer
- What is being tested?
- Aflibercept, Pemetrexed and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 30 Nov 2008to 30 Jun 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Confirmation of cancer by biopsy (tissue sample)
- Phase 1: patients with advanced or metastatic disease that have failed conventional therapy
- Phase 2: patients with previously untreated NSCLC, excluding squamous cell histology and cavitating lesions
- Age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate renal, liver and bone marrow function.
Show all 9Show fewer
- Negative pregnancy test (serum or urine) in females of childbearing potential within 7 days of the initial dose of aflibercept
- Ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- Institutional Review Board (IRB) approved, signed and dated informed consent form
Who cannot join
- Prior treatment with study medications
- Untreated, symptomatic, or progressive Central Nervous System cancer and/or spinal cord compression. Patients with treated brain metastases must have been without symptoms for at least 3 months
- Surgery up to 4 weeks prior to the initial administration of aflibercept and/or incomplete wound healing
- Anti-VEGF therapy up to 4 weeks prior to the initial administration of aflibercept (for phase 1 only)
- Chemotherapy up to 4 weeks prior to the initial administration of aflibercept (for phase 1 only)
- Other investigational treatment up to 4 weeks prior to the initial administration of aflibercept
Show all 13Show fewer
- Any of the following up to 6 months (24 weeks) prior to the initial administration of aflibercept:
- Severe cardiovascular disease or event
- Cerebrovascular accident, transient ischemic attack, or moderate to severe peripheral neuropathy
- Erosive esophagitis or gastritis, infectious or inflammatory bowel disease, and diverticulitis
- Deep vein thrombosis, pulmonary embolism, or other clotting event
- Episode(s)of moderate to severe, continuous bleeding
- Breast-feeding or pregnancy
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States14 sites
UNM Cancer Clinic
Albuquerque, New Mexico, 87131
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231-1000
Palm Beach Institute of Hematology and Oncology
Boynton Beach, Florida, 33435
Roswell Park Cancer Institute
Buffalo, New York, 14263
Presbyterian Hospital Center for Cancer Research
Charlotte, North Carolina, 28204
Erie Regional Cancer Center
Erie, Pennsylvania, 16505
Kentucky Cancer Clinic
Hazard, Kentucky, 41701
Edward Hines Jr. VA Medical Center
Hines, Illinois, 60141
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Arkansas for Medical Science
Little Rock, Arkansas, 72205
Stanford University Medical Center
Stanford, California, 94305
Montefiore Medical Center
The Bronx, New York, 10467
Arizona Cancer Institute, LLC
Tucson, Arizona, 85715
Schiffler Cancer Center - Medical Oncology Division
Wheeling, West Virginia, 26003
About this study
Official title: A Phase 1/2 Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Patients With Advanced Carcinoma
The purpose of the study was to determine whether the combination of aflibercept, pemetrexed and cisplatin is safe and effective in treating non-small cell lung cancer (NSCLC).
Read the detailed description
The study was conducted in two phases. In phase 1, patients with advanced cancer received different doses of aflibercept in combination with approved doses of pemetrexed and cisplatin. The objective of phase 1 was to determine the safest dose of the combined study medications. This dose was administered to patients with previously untreated NSCLC in phase 2. The phase 2 portion of the study determined if the combination is effective in treating NSCLC.
- Conditions
- Advanced Carcinoma, Non-small Cell Lung Cancer
- Being tested
- Aflibercept, Pemetrexed, Cisplatin
- Keywords
- advanced cancer, lung cancer, NSCLC, Non-small Cell Lung Cancer, aflibercept, chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfliberceptDrug
Administered in combination with the other two interventions via intravenous infusion.
PemetrexedDrug
Also called Alimta
Administered in combination with the other two interventions via intravenous infusion.
CisplatinDrug
Also called Platinol
Administered in combination with the other two interventions via intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin | Experimental | Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met. Receives: Drug: Aflibercept; Drug: Pemetrexed; Drug: Cisplatin |
| Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin | Experimental | Participants received intravenous infusion of aflibercept 2 milligrams per kilogram (mg/kg) followed by pemetrexed 500 mg/square meter (m^2) and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met. Receives: Drug: Aflibercept; Drug: Pemetrexed; Drug: Cisplatin |
| Phase 1: Aflibercept 4 mg/kg and Pemetrexed and Cisplatin | Experimental | Participants received intravenous infusion of aflibercept 4 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met. Receives: Drug: Aflibercept; Drug: Pemetrexed; Drug: Cisplatin |
| Phase 2: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin | Experimental | Participants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) for 6 cycles. Receives: Drug: Aflibercept; Drug: Pemetrexed; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Recommended Dose of Aflibercept for Phase 2
Recommended Dose was defined as the highest combination dose at which fewer than 33 percent (%) of participants experienced dose limiting toxicity during the first cycle of therapy.
Measured: Phase 1: Baseline up to 315 Days
Secondary outcomes (13)
Phase 2: Objective Response Rate
Objective response rate was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) as assessed by modified Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking the Baseline sum LD as reference.
Measured: Phase 2: Baseline (Day 421) up to end of study (Day 972)
Phase 2: Progression-free Survival (PFS)
PFS was defined as the time in days from the date of first study drug administration to the date of first documentation of tumor progression or death from any cause, whichever occurs first, as assessed by the modified RECIST. Median time of PFS was estimated using Kaplan-Meier method.
Measured: Phase 2: Baseline (Day 421) up to end of study (Day 972)
Phase 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (for example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) was defined as an adverse event with an onset that occurs after receiving study drug. Any TEAE included participants with both serious and non-serious AEs.
Measured: Phase 1: Baseline up to 751 Days; Phase 2: Baseline (Day 421) up to 972 Days
Phase 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Aflibercept
The AUC0-inf was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.
Measured: Phase 1 and 2: Pre-dose up to Day 22 post-dose
Phase 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Pemetrexed
The AUC0-inf was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.
Measured: Phase 1 and 2: Pre-dose up to Day 1 post-dose, Day 2 post-dose (only in Phase 1)
Phase 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Aflibercept and Pemetrexed
Cmax is the maximum observed plasma concentration obtained directly from the concentration versus time curve.
Measured: Phase 1 and 2: Aflibercept: Pre-dose up to Day 22 post-dose; Pemetrexed: Pre-dose up to Day 1 post-dose, Day 2 post-dose (only in Phase 1)
Phase 1 and 2: Total Body Clearance of Aflibercept
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Measured: Phase 1 and 2: Pre-dose up to Day 22 post-dose
Phase 1 and 2: Total Body Clearance of Pemetrexed
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Measured: Phase 1 and 2: Pre-dose up to Day 1 post-dose, Day 2 post-dose (only in Phase 1)
Phase 1 and 2: Terminal Half-Life (t1/2) of Aflibercept
Terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50 percent in the final stage of its elimination.
Measured: Phase 1 and 2: Pre-dose up to Day 22 post-dose
Phase 1 and 2: Terminal Half-Life (t1/2) of Pemetrexed
Terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50 percent in the final stage of its elimination.
Measured: Phase 1 and 2: Pre-dose up to Day 1 post-dose, Day 2 post-dose (only in Phase 1)
Phase 1 and 2: Number of Participants With Positive Anti-drug Antibody (ADA) of Aflibercept
Serum samples were analyzed by a validated electrochemiluminescence immunoassay to detect the presence of ADA.
Measured: Phase 1: Baseline up to 315 Days; Phase 2: Baseline (Day 421) up to Day 739
Phase 1 and 2: Number of Participants With All Grade Glucose Abnormalities
Measured: Phase 1: Baseline up to 751 Days; Phase 2: Baseline (Day 421) up to 972 Days
Phase 1 and 2: Number of Participants With All Grade Hematology Abnormalities
Measured: Phase 1: Baseline up to 751 Days; Phase 2: Baseline (Day 421) up to 972 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2008 (estimated)
- Study start30 Nov 2008
- Primary completion30 Jun 2011
- Study completion30 Jun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Advanced CarcinomaStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794417
- Sponsor's protocol ID
- VGFT-ST-0708
- Other IDs
- TCD10767
- Status last verified
- Nov 2020
- First submitted
- 19 Nov 2008
- Last updated
- 10 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Diaz-Padilla I, Siu LL, San Pedro-Salcedo M, Razak AR, Colevas AD, Shepherd FA, Leighl NB, Neal JW, Thibault A, Liu L, Lisano J, Gao B, Lawson EB, Wakelee HA. A phase I dose-escalation study of aflibercept administered in combination with pemetrexed and cisplatin in patients with advanced solid tumours. Br J Cancer. 2012 Aug 7;107(4):604-11. doi: 10.1038/bjc.2012.319. Epub 2012 Jul 17.
PubMed 22805331Chen H, Modiano MR, Neal JW, Brahmer JR, Rigas JR, Jotte RM, Leighl NB, Riess JW, Kuo CJ, Liu L, Gao B, Dicioccio AT, Adjei AA, Wakelee HA. A phase II multicentre study of ziv-aflibercept in combination with cisplatin and pemetrexed in patients with previously untreated advanced/metastatic non-squamous non-small cell lung cancer. Br J Cancer. 2014 Feb 4;110(3):602-8. doi: 10.1038/bjc.2013.735. Epub 2013 Nov 28.
PubMed 24292447
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Patients With Advanced Carcinoma
- ClinicalTrials.gov ID
- NCT00794417
- Acronym / sponsor ID
- VGFT-ST-0708
- Conditions
- Advanced Carcinoma, Non-small Cell Lung Cancer
- Keywords
- advanced cancer, lung cancer, NSCLC, Non-small Cell Lung Cancer, aflibercept, chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- 30 Nov 2008 (actual)
- Primary completion
- 30 Jun 2011 (actual)
- Study completion
- 30 Jun 2011 (actual)
- First posted
- 20 Nov 2008 (estimated)
- Results
- Posted 10 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study was to determine whether the combination of aflibercept, pemetrexed and cisplatin is safe and effective in treating non-small cell lung cancer (NSCLC).
Detailed description
The study was conducted in two phases. In phase 1, patients with advanced cancer received different doses of aflibercept in combination with approved doses of pemetrexed and cisplatin. The objective of phase 1 was to determine the safest dose of the combined study medications. This dose was administered to patients with previously untreated NSCLC in phase 2. The phase 2 portion of the study determined if the combination is effective in treating NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin | Experimental | Drug: Aflibercept, Drug: Pemetrexed, Drug: CisplatinParticipants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met. |
| Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin | Experimental | Drug: Aflibercept, Drug: Pemetrexed, Drug: CisplatinParticipants received intravenous infusion of aflibercept 2 milligrams per kilogram (mg/kg) followed by pemetrexed 500 mg/square meter (m^2) and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met. |
| Phase 1: Aflibercept 4 mg/kg and Pemetrexed and Cisplatin | Experimental | Drug: Aflibercept, Drug: Pemetrexed, Drug: CisplatinParticipants received intravenous infusion of aflibercept 4 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) until disease progression, unacceptable toxicity, withdrawal of consent or if another study withdrawal criterion has been met. |
| Phase 2: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin | Experimental | Drug: Aflibercept, Drug: Pemetrexed, Drug: CisplatinParticipants received intravenous infusion of aflibercept 6 mg/kg followed by pemetrexed 500 mg/m^2 and then cisplatin 75 mg/m^2 on Day 1 of each 3 week cycle (1 Cycle = 21 Days in this study) for 6 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Confirmation of cancer by biopsy (tissue sample)
- Phase 1: patients with advanced or metastatic disease that have failed conventional therapy
- Phase 2: patients with previously untreated NSCLC, excluding squamous cell histology and cavitating lesions
- Age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Key exclusion criteria (13 listed)
- Prior treatment with study medications
- Untreated, symptomatic, or progressive Central Nervous System cancer and/or spinal cord compression. Patients with treated brain metastases must have been without symptoms for at least 3 months
- Surgery up to 4 weeks prior to the initial administration of aflibercept and/or incomplete wound healing
- Anti-VEGF therapy up to 4 weeks prior to the initial administration of aflibercept (for phase 1 only)
- Chemotherapy up to 4 weeks prior to the initial administration of aflibercept (for phase 1 only)
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 |
|---|---|---|
| AfliberceptAdministered in combination with the other two interventions via intravenous infusion. | Drug | Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin, Phase 1: Aflibercept 4 mg/kg and Pemetrexed and Cisplatin, Phase 1: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin, Phase 2: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin |
| PemetrexedAlso: AlimtaAdministered in combination with the other two interventions via intravenous infusion. | Drug | Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin, Phase 1: Aflibercept 4 mg/kg and Pemetrexed and Cisplatin, Phase 1: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin, Phase 2: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin |
| CisplatinAlso: PlatinolAdministered in combination with the other two interventions via intravenous infusion. | Drug | Phase 1: Aflibercept 2 mg/kg and Pemetrexed and Cisplatin, Phase 1: Aflibercept 4 mg/kg and Pemetrexed and Cisplatin, Phase 1: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin, Phase 2: Aflibercept 6 mg/kg and Pemetrexed and Cisplatin |
Primary outcome
Phase 1: Recommended Dose of Aflibercept for Phase 2
Time frame: Phase 1: Baseline up to 315 Days
Recommended Dose was defined as the highest combination dose at which fewer than 33 percent (%) of participants experienced dose limiting toxicity during the first cycle of therapy.
13 secondary outcomes
Phase 2: Objective Response Rate
Time frame: Phase 2: Baseline (Day 421) up to end of study (Day 972)
Phase 2: Progression-free Survival (PFS)
Time frame: Phase 2: Baseline (Day 421) up to end of study (Day 972)
Phase 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Phase 1: Baseline up to 751 Days; Phase 2: Baseline (Day 421) up to 972 Days
Phase 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Aflibercept
Time frame: Phase 1 and 2: Pre-dose up to Day 22 post-dose
Phase 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Pemetrexed
Time frame: Phase 1 and 2: Pre-dose up to Day 1 post-dose, Day 2 post-dose (only in Phase 1)
Phase 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Aflibercept and Pemetrexed
Time frame: Phase 1 and 2: Aflibercept: Pre-dose up to Day 22 post-dose; Pemetrexed: Pre-dose up to Day 1 post-dose, Day 2 post-dose (only in Phase 1)
Phase 1 and 2: Total Body Clearance of Aflibercept
Time frame: Phase 1 and 2: Pre-dose up to Day 22 post-dose
Phase 1 and 2: Total Body Clearance of Pemetrexed
Time frame: Phase 1 and 2: Pre-dose up to Day 1 post-dose, Day 2 post-dose (only in Phase 1)
Phase 1 and 2: Terminal Half-Life (t1/2) of Aflibercept
Time frame: Phase 1 and 2: Pre-dose up to Day 22 post-dose
Phase 1 and 2: Terminal Half-Life (t1/2) of Pemetrexed
Time frame: Phase 1 and 2: Pre-dose up to Day 1 post-dose, Day 2 post-dose (only in Phase 1)
Phase 1 and 2: Number of Participants With Positive Anti-drug Antibody (ADA) of Aflibercept
Time frame: Phase 1: Baseline up to 315 Days; Phase 2: Baseline (Day 421) up to Day 739
Phase 1 and 2: Number of Participants With All Grade Glucose Abnormalities
Time frame: Phase 1: Baseline up to 751 Days; Phase 2: Baseline (Day 421) up to 972 Days
Phase 1 and 2: Number of Participants With All Grade Hematology Abnormalities
Time frame: Phase 1: Baseline up to 751 Days; Phase 2: Baseline (Day 421) up to 972 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22805331Diaz-Padilla I, Siu LL, San Pedro-Salcedo M, Razak AR, Colevas AD, Shepherd FA, Leighl NB, Neal JW, Thibault A, Liu L, Lisano J, Gao B, Lawson EB, Wakelee HA. A phase I dose-escalation study of aflibercept administered in combination with pemetrexed and cisplatin in patients with advanced solid tumours. Br J Cancer. 2012 Aug 7;107(4):604-11. doi: 10.1038/bjc.2012.319. Epub 2012 Jul 17.
- Results publication: PubMed 24292447Chen H, Modiano MR, Neal JW, Brahmer JR, Rigas JR, Jotte RM, Leighl NB, Riess JW, Kuo CJ, Liu L, Gao B, Dicioccio AT, Adjei AA, Wakelee HA. A phase II multicentre study of ziv-aflibercept in combination with cisplatin and pemetrexed in patients with previously untreated advanced/metastatic non-squamous non-small cell lung cancer. Br J Cancer. 2014 Feb 4;110(3):602-8. doi: 10.1038/bjc.2013.735. Epub 2013 Nov 28.
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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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Aflibercept, Pemetrexed and Cisplatin in people with Advanced Carcinoma and Non-small Cell Lung Cancer, run by Regeneron Pharmaceuticals at 15 sites in 2 countries.
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 9 inclusion and 13 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: stopped early, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Canada. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Phase 1: Recommended Dose of Aflibercept for Phase 2 (time frame: Phase 1: Baseline up to 315 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00794417, which also lists 2 linked publications.
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 10 Dec 2020.