Non Small Cell Lung Cancer (NSCLC)Phase 1NCT01323062
Bavituximab Plus Carbo and Pemetrexed in Chemo-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Subjects
A Phase 1 study testing Bavituximab in people with Non Small Cell Lung Cancer (NSCLC), run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.
Trial summary
This is a non-randomized, open-label Phase 1b trial to establish the safety and recommended phase 2 dose (RP2D) of bavituximab in combination with pemetrexed and carboplatin in subjects with previously untreated stage IV non-squamous 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
- Non Small Cell Lung Cancer (NSCLC)
- What is being tested?
- Bavituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2011to 1 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than or equal to 18
- Histologically or cytologically confirmed stage IV non-squamous NSCLC not previously treated with systemic chemotherapy
- Evaluable disease by clinical or radiographic parameters
- No history or concomitant malignancy
- Adequate organ and marrow function
- Female subjects with negative urine or serum pregnancy
- ECOG must be 0 or 1
Who cannot join
- Squamous cell, small cell, or mixed histology
- Known history of bleeding diathesis or coagulopathy
- Cavitary tumors or tumors invading or abutting large blood vessels
- Any history of thromboembolic events
- Ongoing therapy with oral or parenteral anticoagulants
- Major surgery within 4 weeks of Day 1 of treatment
Show all 14Show fewer
- Uncontrolled intercurrent disease (diabetes, hypertension, thyroid disease)
- any history of significant vascular disease
- Congestive heart failure
- History of any condition requiring anti-platelet therapy
- Serious non healing wound
- Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis
- Unable or unwilling to discontinue use of prohibited medications
- D-dimers >2 x ULN as measured on 2 separate occasions at least 1 day apart
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: A Phase 1b Study of Bavituximab Plus Carboplatin and Pemetrexed in Chemotherapy-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer
This is a non-randomized, open-label Phase 1b trial to establish the safety and recommended phase 2 dose (RP2D) of bavituximab in combination with pemetrexed and carboplatin in subjects with previously untreated stage IV non-squamous non-small cell lung cancer (NSCLC).
Read the detailed description
Subjects with measurable disease will be assessed for response after every 2 cycles of therapy using RECIST 1.1 criteria. In addition, progression free survival (PFS), overall survival (OS) and exploratory biomarkers, imaging, and thrombotic risk parameters will be evaluated.
- Conditions
- Non Small Cell Lung Cancer (NSCLC)
- Being tested
- Bavituximab
- Keywords
- chemotherapy naive, stage IV non squamous non small cell lung cancer, Phase 1b, Bavituximab, Chimeric 3G4, U of North Carolina at Chapel Hill
- 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.
BavituximabDrug
Also called chimeric 3G4
Administered 3 mg/kg weekly
| Study group | Role | What they receive |
|---|---|---|
| Single-arm trial | Other | Single-arm trial Receives: Drug: Bavituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure number of severe side effects seen during first cycle of therapy
To determine the maximum tolerated dose based on occurrence of dose-limititing toxicity (DLT) within the first 3 weeks of treatment to determine appropriate and safe dose of bavituximab in combination with carboplatin and pemetrexed
Measured: Three weeks
Secondary outcomes (1)
Progression free survival
to determine the overall response rate and estimate progression free survival associated with bavituximab in combination with carboplatin and pemetrexed
Measured: At the time from the start of treatment until documented disease as defined bia RECIST 1.1 or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2011 (estimated)
- Study startMay 2011
- Primary completion14 May 2014
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by UNC Lineberger 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Peregrine Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Juneko Grilley Olson, MD, Principal investigator, U of North Carolina at Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01323062
- Sponsor's protocol ID
- LCCC 1030
- Status last verified
- Dec 2018
- First submitted
- 8 Mar 2011
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of Bavituximab Plus Carboplatin and Pemetrexed in Chemotherapy-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01323062
- Acronym / sponsor ID
- LCCC 1030
- Conditions
- Non Small Cell Lung Cancer (NSCLC)
- Keywords
- chemotherapy naive, stage IV non squamous non small cell lung cancer, Phase 1b, Bavituximab, Chimeric 3G4, U of North Carolina at Chapel Hill
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Peregrine Pharmaceuticals
- Study start
- May 2011
- Primary completion
- 14 May 2014 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 25 Mar 2011 (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 is a non-randomized, open-label Phase 1b trial to establish the safety and recommended phase 2 dose (RP2D) of bavituximab in combination with pemetrexed and carboplatin in subjects with previously untreated stage IV non-squamous non-small cell lung cancer (NSCLC).
Detailed description
Subjects with measurable disease will be assessed for response after every 2 cycles of therapy using RECIST 1.1 criteria. In addition, progression free survival (PFS), overall survival (OS) and exploratory biomarkers, imaging, and thrombotic risk parameters will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm trial | Other | Drug: BavituximabSingle-arm trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Greater than or equal to 18
- Histologically or cytologically confirmed stage IV non-squamous NSCLC not previously treated with systemic chemotherapy
- Evaluable disease by clinical or radiographic parameters
- No history or concomitant malignancy
- Adequate organ and marrow function
Key exclusion criteria (14 listed)
- Squamous cell, small cell, or mixed histology
- Known history of bleeding diathesis or coagulopathy
- Cavitary tumors or tumors invading or abutting large blood vessels
- Any history of thromboembolic events
- Ongoing therapy with oral or parenteral anticoagulants
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 |
|---|---|---|
| BavituximabAlso: chimeric 3G4Administered 3 mg/kg weekly | Drug | Single-arm trial |
Primary outcome
Measure number of severe side effects seen during first cycle of therapy
Time frame: Three weeks
To determine the maximum tolerated dose based on occurrence of dose-limititing toxicity (DLT) within the first 3 weeks of treatment to determine appropriate and safe dose of bavituximab in combination with carboplatin and pemetrexed
1 secondary outcome
Progression free survival
Time frame: At the time from the start of treatment until documented disease as defined bia RECIST 1.1 or death
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 4 Dec 2018.
- web address for Lineberger Comprehensive Cancer Center, UNCLink provided by the sponsor.
- web address for the National Cancer Institute (NCI)Link provided by the sponsor.
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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.
Juneko Grilley Olson, MD principal investigator
U of North Carolina at Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bavituximab in people with Non Small Cell Lung Cancer (NSCLC), run by UNC Lineberger Comprehensive Cancer Center at 2 sites 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 7 inclusion and 14 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 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Measure number of severe side effects seen during first cycle of therapy (time frame: Three weeks). 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 4 Dec 2018.