Lung CancerPhase 1NCT00424840
Phase I/II Study to Evaluate the Efficacy and Safety of a Combination Chemotherapy
A Phase 1 study testing Bortezomib 1.3 mg/m2, Bortezomib 1.6 mg/m2 and Bortezomib 1.8 mg/m2 in people with Lung Cancer, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
A pilot trial of combination of bortezomib, bevacizumab and carboplatin as first line therapy in patients with metastatic Non-Small Cell Lung Cancer (NSCLC). Phase I and II study of this combination in first line setting will be conducted in order to properly estimate the efficacy and safety of this regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Bortezomib 1.3 mg/m2, Bortezomib 1.6 mg/m2 and Bortezomib 1.8 mg/m2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Mar 2014
- Phase
- Phase 1
- 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
- Histologically confirmed SCLC (adeno- and large cell, anaplastic carcinoma and broncho-alveolar-carcinoma). Patients with squamous-cell histology are eligible with extra thoracic or peripheral lung lesions only.
- Sputum cytology alone not acceptable evidence of cell type. Cytologic specimens obtained by brushing, washings, or needle aspiration of defined lesions will be acceptable. Mixed tumors will be categorized by the predominant cell type unless a small cell anaplastic elements are present, in which case the patient is ineligible.
- Stage III B because of pleural effusion or Stage IV disease
- Measurable disease.
- Age: 18 years or older
- No history of thrombotic, hemorrhagic, or coagulopathy disorders
Show all 20Show fewer
- international normalized ratio (INR<1.5) and a prothrombin time (PTT) no greater than normal limits of normal within 1 week prior to registration. NB: subjects with lung cancer placed on anticoagulant therapy for a thrombotic event are not eligible for this study.
- No gross hemoptysis (defined as bright red blood of ½ teaspoon or more)
- No central nervous system (CNS) or brain metastasis
- Laboratory Criteria (completed <2 weeks before enrollment):
- Hematologic: white blood cell (WBC) > 3500/mm3 or absolute neutrophil count (ANC) > 1500/mm3 and platelet count > 100 000/ mm3;
- Hepatic: Total bilirubin < 1.5 mg/dl
- Renal: Creatinine < 1.5 mg/dl. or calculated
- Creatinine clearance > 45 ml/min (NB: Urine protein:creatinine ratio in exclusion criteria)
- Eastern Cooperative Oncology Group (ECOG) performance status < 2
- Be free of active infection.
- Be available for active follow up.
- No prior chemotherapy for metastatic disease.
- Be disease free for > 5 years if they had a prior second malignancy other than treated basal cell carcinoma or squamous cell skin cancer, or carcinoma in situ of the cervix.
- Female subject post-menopausal; surgically sterilized or willing to use an acceptable method of birth control for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study.
Who cannot join
- CNS or brain metastasis
- Patient has = or greater Grade 2 peripheral neuropathy within 14 days before enrollment.
- Known previous sensitivity reactions with boron, or mannitol,
- Patients with known HIV positivity
- Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
- Blood pressure of >150/100 mmHG
Show all 17Show fewer
- History of myocardial infarction or stroke within 6 months
- Clinically significant peripheral vascular disease
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study.
- Minor surgical procedure such as fine needle aspirations or core biopsies within 7 days prior to day 0
- Urine protein: Creatinine ratio > 1.0 at screening
- History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 6 months prior to Day 0
- Serious, non-healing wound, ulcer, or bone fracture
- Lung carcinoma or any histology in close proximity to a major vessel or cavitation
- Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- Patient has received other investigational drugs with 14 days before enrollment or is expected to participate in an experiment drug study during this study treatment.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655-0002
About this study
Official title: Phase I/II Study to Evaluate the Efficacy and Safety of Combination Chemotherapy With Carboplatin, Bortezomib and Bevacizumab as First Line Therapy in Patients With Advanced Non-small Cell Lung Cancer
A pilot trial of combination of bortezomib, bevacizumab and carboplatin as first line therapy in patients with metastatic Non-Small Cell Lung Cancer (NSCLC). Phase I and II study of this combination in first line setting will be conducted in order to properly estimate the efficacy and safety of this regimen. This will form the basis for future studies comparing this combination to what is now considered standard regimen for first line therapy in patients with NSCLC, carboplatin, paclitaxel and bevacizumab.
Read the detailed description
Study design and methodology The study will have two phases.
The phase I will use traditional dose escalation model (3-6 patient per dose level) to determine the maximum tolerated dose (MTD).
*[In phase II, either level III or (MTD) will be used in the same every 21 day cycle to evaluate the efficacy and safety of the regimen in first line treatment of advanced NSCLC]* not conducted.
Treatments administered
In phase I, three dose levels of weekly bortezomib will be studied in conjunction with fixed dose carboplatin and bevacizumab on a 21 day cycle to define the maximum tolerated dose (MTD).
A maximum of six cycles will be administered. Patients with complete response, partial response or stable disease after six cycles will be allowed to continue on single agent bevacizumab every 3 weeks as maintenance therapy until disease progression.
If no dose limiting toxicity (DLT) is observed in 3 patients during the first cycle, the next dose level will be accrued. If 1 DLT is observed, 3 additional patients will be accrued to the dose level. If no additional DLTs are observed, the next dose level will be accrued. However, if 2 or more DLTs are observed in a given dose level, MTD will be defined. MTD will be defined as the dose below which ≥2 DLTs were observed.
The following three levels will be studied:
Level I (every 21 day cycle): D1: carboplatin AUC 6, bevacizumab 15 mg/kg, bortezomib 1.3 mg/m2 D8 : bortezomib 1.3 mg/m2
Level II (every 21 day cycle): D1: carboplatin AUC 6, bevacizumab 15 mg/kg, bortezomib 1.6 mg/m2 D8 : bortezomib 1.6 mg/m2
Level III(every 21 day cycle):D1: carboplatin AUC 6, bevacizumab 15 mg/kg, bortezomib 1.8 mg/m2 D8 : bortezomib 1.8 mg/m2
If 2 or more DLT are observed in Level 1, level -1 will be accrued.
Level -1: (every 21 day cycle): D1: carboplatin AUC 6, bevacizumab 15 mg/kg, bortezomib 1 mg/m2 D8: bortezomib 1 mg/m2
*[In phase II, either level III or the MTD dose level will be used in the same every 21 day cycle to evaluate the efficacy and safety of the regimen in first line treatment of advanced NSCLC.
Efficacy data collected
The following evaluations will be conducted to assess the efficacy of the combination:
- response rate by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- disease free and overall survival, time to progress (TTP) and duration of response Safety data collected
The following evaluations will be conducted to assess the safety of the combination chemotherapy:
- toxicity based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0]* Not conducted
Statistical procedures
In phase I portion, 9-18 patients will be enrolled. The patients treated at recommended dose level for phase II will also be eligible for response evaluation as part of phase II.
*[The primary objective of the phase II study is to estimate the efficacy and safety of the combination therapy with carboplatin, bortezomib and bevacizumab as the first line therapy in patients with advanced NSCLC. The primary endpoints are response rate and progression-free survival (PFS).
(NOT CONDUCTED) In phase II portion, the optimal two-stage design for phase II clinical trials described by Simon et al. will be utilized.
Overall survival, progression free survival and time to progression will be estimated using Kaplan-Meier methods. Time to progression, progression free survival and survival will be calculated from the date of study entry.]* (Phase II not conducted.)
- Conditions
- Lung Cancer
- Being tested
- Bortezomib 1.3 mg/m2, Bortezomib 1.6 mg/m2, Bortezomib 1.8 mg/m2, Carboplatin AUC 6, Bevacizumab
- Keywords
- lung cancer, Carboplatin, bortezomib, Bevacizumab
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bortezomib 1.3 mg/m2Drug
Also called Velcade
Level I (every 21 day cycle, D8), 1.3 mg/m2:
Day 1: bevacizumab 15 mg/kg ,carboplatin Area Under the Curve (AUC 6) 900mg, bortezomib 1.3 mg/m2 Day 8 : bortezomib 1.3 mg/m2
Level II (every 21 day cycle):
Day 1: bevacizumab 15 mg/kg, carboplatin Area Under the Curve (AUC 6) 900mg, bortezomib 1.6 mg/m2 Day 8 : bortezomib 1.6 mg/m2
Level III(every 21 day cycle):
Day 1: bevacizumab 15 mg/kg, carboplatin Area Under the Curve (AUC 6) 900mg, bortezomib 1.8 mg/m2 Day 8 : bortezomib 1.8 mg/m2
Bortezomib 1.6 mg/m2Drug
Also called Velcade
Level II (every 21 day cycle, D8), 1.6 mg/m2
Bortezomib 1.8 mg/m2Drug
Also called Velcade
Level III (every 21 day cycle, D8) 1.8 mg/m2
Carboplatin AUC 6Drug
Also called Carboplatin
Carboplatin AUC6
BevacizumabDrug
Bevacizumab 15 mg/kg
TaxotereDrug
Taxotere 70 + G-CSF
| Study group | Role | What they receive |
|---|---|---|
| Bortezomib 1.3 mg/m2 | Experimental | Level 1 of Bortezomib Dose Escalation in combination with Carboplatin AUC6, Bevacizumab 15 mg/kg and Taxotere 70 + G-CSF Receives: Drug: Bortezomib 1.3 mg/m2; Drug: Carboplatin AUC 6; Drug: Bevacizumab; Drug: Taxotere |
| Bortezomib 1.6 mg/m2 | Experimental | Level 2 of Bortezomib Dose Escalation in combination with Carboplatin AUC6, Bevacizumab 15 mg/kg and Taxotere 70 + G-CSF Receives: Drug: Bortezomib 1.6 mg/m2; Drug: Carboplatin AUC 6; Drug: Bevacizumab; Drug: Taxotere |
| Bortezomib 1.8 mg/m2 | Experimental | Level 3 of Bortezomib Dose Escalation in combination with Carboplatin AUC6, Bevacizumab 15 mg/kg and Taxotere 70 + G-CSF Receives: Drug: Bortezomib 1.8 mg/m2; Drug: Carboplatin AUC 6; Drug: Bevacizumab; Drug: Taxotere |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Require Dose Delay/Reduction in Dose of Bortezomibin the First Cycle
Dose limiting toxicity at Level 1,2 and 3: Number of subjects who required dose delay/reduction in dose of bortezomib in the first cycle of treatment. DLT defined by any of the following during first cycle: (1) GR4 neutropenia or thrombocytopenia, (2) Greater than GR3 non-hematological toxicity except alopecia or inadequately treated nausea or vomiting or (3) neurosensory toxicity of GR2 with pain or any neurotoxicity greater than GR2.
Measured: up to 21 days for each dosing cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2007 (estimated)
- Study startJun 2006
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Poor accrual
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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc., Genentech, Inc.
- Responsible party
- Principal investigator, William Walsh, University of Massachusetts, Worcester
- Investigators
- William Walsh, MD, Principal investigator, University of MassachusettsMedical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424840
- Sponsor's protocol ID
- UM200601
- Status last verified
- Jan 2019
- First submitted
- 18 Jan 2007
- Last updated
- 1 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.
PubMed 2702835Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006 Dec 14;355(24):2542-50. doi: 10.1056/NEJMoa061884.
PubMed 17167137
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study to Evaluate the Efficacy and Safety of Combination Chemotherapy With Carboplatin, Bortezomib and Bevacizumab as First Line Therapy in Patients With Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00424840
- Acronym / sponsor ID
- UM200601
- Conditions
- Lung Cancer
- Keywords
- lung cancer, Carboplatin, bortezomib, Bevacizumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc., Genentech, Inc.
- Study start
- Jun 2006
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 22 Jan 2007 (estimated)
- Results
- Posted 1 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot trial of combination of bortezomib, bevacizumab and carboplatin as first line therapy in patients with metastatic Non-Small Cell Lung Cancer (NSCLC). Phase I and II study of this combination in first line setting will be conducted in order to properly estimate the efficacy and safety of this regimen. This will form the basis for future studies comparing this combination to what is now considered standard regimen for first line therapy in patients with NSCLC, carboplatin, paclitaxel and bevacizumab.
Detailed description
Study design and methodology The study will have two phases.
The phase I will use traditional dose escalation model (3-6 patient per dose level) to determine the maximum tolerated dose (MTD).
*[In phase II, either level III or (MTD) will be used in the same every 21 day cycle to evaluate the efficacy and safety of the regimen in first line treatment of advanced NSCLC]* not conducted.
Treatments administered
In phase I, three dose levels of weekly bortezomib will be studied in conjunction with fixed dose carboplatin and bevacizumab on a 21 day cycle to define the maximum tolerated dose (MTD).
A maximum of six cycles will be administered. Patients with complete response, partial response or stable disease after six cycles will be allowed to continue on single agent bevacizumab every 3 weeks as maintenance therapy until disease progression.
If no dose limiting toxicity (DLT) is observed in 3 patients during the first cycle, the next dose level will be accrued. If 1 DLT is observed, 3 additional patients will be accrued to the dose level. If no additional DLTs are observed, the next dose level will be accrued. However, if 2 or more DLTs are observed in a given dose level, MTD will be defined. MTD will be defined as the dose below which ≥2 DLTs were observed.
The following three levels will be studied:
Level I (every 21 day cycle): D1: carboplatin AUC 6, bevacizumab 15 mg/kg, bortezomib 1.3 mg/m2 D8 : bortezomib 1.3 mg/m2
Level II (every 21 day cycle): D1: carboplatin AUC 6, bevacizumab 15 mg/kg, bortezomib 1.6 mg/m2 D8 : bortezomib 1.6 mg/m2
Level III(every 21 day cycle):D1: carboplatin AUC 6, bevacizumab 15 mg/kg, bortezomib 1.8 mg/m2 D8 : bortezomib 1.8 mg/m2
If 2 or more DLT are observed in Level 1, level -1 will be accrued.
Level -1: (every 21 day cycle): D1: carboplatin AUC 6, bevacizumab 15 mg/kg, bortezomib 1 mg/m2 D8: bortezomib 1 mg/m2
*[In phase II, either level III or the MTD dose level will be used in the same every 21 day cycle to evaluate the efficacy and safety of the regimen in first line treatment of advanced NSCLC.
Efficacy data collected
The following evaluations will be conducted to assess the efficacy of the combination:
- response rate by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- disease free and overall survival, time to progress (TTP) and duration of response Safety data collected
The following evaluations will be conducted to assess the safety of the combination chemotherapy:
- toxicity based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0]* Not conducted
Statistical procedures
In phase I portion, 9-18 patients will be enrolled. The patients treated at recommended dose level for phase II will also be eligible for response evaluation as part of phase II.
*[The primary objective of the phase II study is to estimate the efficacy and safety of the combination therapy with carboplatin, bortezomib and bevacizumab as the first line therapy in patients with advanced NSCLC. The primary endpoints are response rate and progression-free survival (PFS).
(NOT CONDUCTED) In phase II portion, the optimal two-stage design for phase II clinical trials described by Simon et al. will be utilized.
Overall survival, progression free survival and time to progression will be estimated using Kaplan-Meier methods. Time to progression, progression free survival and survival will be calculated from the date of study entry.]* (Phase II not conducted.)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bortezomib 1.3 mg/m2 | Experimental | Drug: Bortezomib 1.3 mg/m2, Drug: Carboplatin AUC 6, Drug: Bevacizumab, Drug: TaxotereLevel 1 of Bortezomib Dose Escalation in combination with Carboplatin AUC6, Bevacizumab 15 mg/kg and Taxotere 70 + G-CSF |
| Bortezomib 1.6 mg/m2 | Experimental | Drug: Bortezomib 1.6 mg/m2, Drug: Carboplatin AUC 6, Drug: Bevacizumab, Drug: TaxotereLevel 2 of Bortezomib Dose Escalation in combination with Carboplatin AUC6, Bevacizumab 15 mg/kg and Taxotere 70 + G-CSF |
| Bortezomib 1.8 mg/m2 | Experimental | Drug: Bortezomib 1.8 mg/m2, Drug: Carboplatin AUC 6, Drug: Bevacizumab, Drug: TaxotereLevel 3 of Bortezomib Dose Escalation in combination with Carboplatin AUC6, Bevacizumab 15 mg/kg and Taxotere 70 + G-CSF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Histologically confirmed SCLC (adeno- and large cell, anaplastic carcinoma and broncho-alveolar-carcinoma). Patients with squamous-cell histology are eligible with extra thoracic or peripheral lung lesions only.
- Sputum cytology alone not acceptable evidence of cell type. Cytologic specimens obtained by brushing, washings, or needle aspiration of defined lesions will be acceptable. Mixed tumors will be categorized by the predominant cell type unless a small cell anaplastic elements are present, in which case the patient is ineligible.
- Stage III B because of pleural effusion or Stage IV disease
- Measurable disease.
- Age: 18 years or older
Key exclusion criteria (17 listed)
- CNS or brain metastasis
- Patient has = or greater Grade 2 peripheral neuropathy within 14 days before enrollment.
- Known previous sensitivity reactions with boron, or mannitol,
- Patients with known HIV positivity
- Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
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 |
|---|---|---|
| Bortezomib 1.3 mg/m2Also: VelcadeLevel I (every 21 day cycle, D8), 1.3 mg/m2: Day 1: bevacizumab 15 mg/kg ,carboplatin Area Under the Curve (AUC 6) 900mg, bortezomib 1.3 mg/m2 Day 8 : bortezomib 1.3 mg/m2 Level II (every 21 day cycle): Day 1: bevacizumab 15 mg/kg, carboplatin Area Under the Curve (AUC 6) 900mg, bortezomib 1.6 mg/m2 Day 8 : bortezomib 1.6 mg/m2 Level III(every 21 day cycle): Day 1: bevacizumab 15 mg/kg, carboplatin Area Under the Curve (AUC 6) 900mg, bortezomib 1.8 mg/m2 Day 8 : bortezomib 1.8 mg/m2 | Drug | Bortezomib 1.3 mg/m2 |
| Bortezomib 1.6 mg/m2Also: VelcadeLevel II (every 21 day cycle, D8), 1.6 mg/m2 | Drug | Bortezomib 1.6 mg/m2 |
| Bortezomib 1.8 mg/m2Also: VelcadeLevel III (every 21 day cycle, D8) 1.8 mg/m2 | Drug | Bortezomib 1.8 mg/m2 |
| Carboplatin AUC 6Also: CarboplatinCarboplatin AUC6 | Drug | Bortezomib 1.3 mg/m2, Bortezomib 1.6 mg/m2, Bortezomib 1.8 mg/m2 |
| BevacizumabBevacizumab 15 mg/kg | Drug | Bortezomib 1.3 mg/m2, Bortezomib 1.6 mg/m2, Bortezomib 1.8 mg/m2 |
| TaxotereTaxotere 70 + G-CSF | Drug | Bortezomib 1.3 mg/m2, Bortezomib 1.6 mg/m2, Bortezomib 1.8 mg/m2 |
Primary outcome
Number of Subjects Who Require Dose Delay/Reduction in Dose of Bortezomibin the First Cycle
Time frame: up to 21 days for each dosing cycle
Dose limiting toxicity at Level 1,2 and 3: Number of subjects who required dose delay/reduction in dose of bortezomib in the first cycle of treatment. DLT defined by any of the following during first cycle: (1) GR4 neutropenia or thrombocytopenia, (2) Greater than GR3 non-hematological toxicity except alopecia or inadequately treated nausea or vomiting or (3) neurosensory toxicity of GR2 with pain or any neurotoxicity greater than GR2.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 2702835Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.
- Background: PubMed 17167137Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006 Dec 14;355(24):2542-50. doi: 10.1056/NEJMoa061884.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
RecruitingPhase 3
A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
Non-small Cell Lung Cancer
Recruiting
More Than Just X-Rays - Imaging of Chemotherapy-induced Morphological and Functional Cardiovascular and Lung Changes After Childhood ALL and Other Cancers - a Monocentric Late Effects Study (MaximALL)
Acute Lymphatic Leukemia, Lymphoma
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
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.
William Walsh, MD principal investigator
University of MassachusettsMedical School
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 Bortezomib 1.3 mg/m2, Bortezomib 1.6 mg/m2 and Bortezomib 1.8 mg/m2 in people with Lung Cancer, run by University of Massachusetts, Worcester 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 20 inclusion and 17 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 1 Feb 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?
Yes. Results are posted in the registry (first posted 1 Feb 2019). 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?
Number of Subjects Who Require Dose Delay/Reduction in Dose of Bortezomibin the First Cycle (time frame: up to 21 days for each dosing cycle). 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 NCT00424840, 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 1 Feb 2019.