Non-Small Cell Lung CancerPhase 2NCT00480831
A Study of PRO95780 in Patients With Previously Untreated, Advanced-Stage Non-Small Cell Lung Cancer (APM4074g)
A Phase 2 study testing bevacizumab, carboplatin and paclitaxel in people with Non-Small Cell Lung Cancer, run by Genentech, Inc..
Trial summary
This is a randomized, double-blind, Phase II, placebo-controlled trial adding on to a background of effective treatment designed to evaluate the efficacy, safety, and pharmacokinetics of PRO95780 combined with paclitaxel + carboplatin + bevacizumab therapy in patients with previously untreated Stage IIIB, Stage IV, or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- bevacizumab, carboplatin and paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Aug 2010
- Phase
- Phase 2
- 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
- Ability to understand and willingness to sign a written informed consent
- Histologically or cytologically confirmed NSCLC
- Advanced NSCLC
- Measurable disease
- ECOG performance status of 0 or 1
- Age ≥ 18 years
- Use of accepted and effective method of contraception, i.e., double barrier contraceptive methods (e.g., diaphragm plus condom) or abstinence during the course of the study and for 6 months after the last study treatment administration for women, and 1 month for men
Who cannot join
- Squamous cell histology
- Prior malignancy other than NSCLC (except in situ basal cell carcinoma or in situ cervical cancer), unless it has been treated with curative intent and there is no evidence of disease for ≥ 3 years prior to randomization
- Untreated or unstable CNS metastases
- Myocardial infarction or an unstable or uncontrolled disease or condition related to or impacting cardiac function within 1 year prior to randomization
- Uncontrolled hypertension
- History of arterial thrombosis, stroke, or serious hemorrhagic disorder within 1 year prior to randomization
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- Major surgical procedure within 28 days prior to randomization
- Serious non-healing wound ulcer, or bone fracture within 21 days prior to randomization
- Persistent history of gross hemoptysis relating to the patient's NSCLC
- Known HIV infection
- Known to be positive for hepatitis C or hepatitis B surface antigen
- Chronic daily treatment with aspirin or nonsteroidal anti-inflammatory agents known to inhibit platelet function
- Use of anticoagulation therapy
- Participation in clinical trials or undergoing other investigational procedures within 30 days prior to randomization
- Pregnancy (e.g., positive HCG test) or breast feeding
- Known sensitivity to any of the products to be administered during the study
- Any disorder that compromises the ability of the patient to provide written informed consent and/or to comply with study procedures
About this study
Official title: A Randomized, Double-Blind, Phase II Trial of Paclitaxel + Carboplatin + Bevacizumab With or Without PRO95780 in Patients With Previously Untreated, Advanced-Stage Non-Small Cell Lung Cancer
This is a randomized, double-blind, Phase II, placebo-controlled trial adding on to a background of effective treatment designed to evaluate the efficacy, safety, and pharmacokinetics of PRO95780 combined with paclitaxel + carboplatin + bevacizumab therapy in patients with previously untreated Stage IIIB, Stage IV, or recurrent non-small cell lung cancer (NSCLC). Approximately 120 patients will be randomized to one of two treatment arms.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- bevacizumab, carboplatin, paclitaxel, placebo, PRO95780
- Keywords
- NSCLC, Cancer, Avastin, APM4074g
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabDrug
Intravenous repeating dose
carboplatinDrug
Intravenous repeating dose
paclitaxelDrug
Intravenous repeating dose
placeboDrug
Intravenous repeating dose
PRO95780Drug
Intravenous repeating dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: bevacizumab; Drug: carboplatin; Drug: paclitaxel; Drug: PRO95780 |
| 2 | Placebo comparator | Not described Receives: Drug: bevacizumab; Drug: carboplatin; Drug: paclitaxel; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: Length of study
Changes in vital signs, physical findings, and clinical laboratory results during and following PRO95780 administration
Measured: Length of study
Progression-free survival, as determined by independent review facility
Measured: Length of study
Secondary outcomes (4)
Objective response and duration of response, as determined by independent review facility
Measured: Length of study
Overall survival
Measured: 24 months
Progression-free survival, objective response, and duration of objective response, as determined by the investigator
Measured: Length of study
Pharmacokinetic parameters
Measured: Length of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2007 (estimated)
- Study startJun 2007
- Primary completionAug 2010
- Study completionAug 2010
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 CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gordon Bray, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480831
- Sponsor's protocol ID
- APM4074g
- Status last verified
- May 2017
- First submitted
- 30 May 2007
- Last updated
- 18 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Phase II Trial of Paclitaxel + Carboplatin + Bevacizumab With or Without PRO95780 in Patients With Previously Untreated, Advanced-Stage Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00480831
- Acronym / sponsor ID
- APM4074g
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- NSCLC, Cancer, Avastin, APM4074g
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2007 (actual)
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 31 May 2007 (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 randomized, double-blind, Phase II, placebo-controlled trial adding on to a background of effective treatment designed to evaluate the efficacy, safety, and pharmacokinetics of PRO95780 combined with paclitaxel + carboplatin + bevacizumab therapy in patients with previously untreated Stage IIIB, Stage IV, or recurrent non-small cell lung cancer (NSCLC). Approximately 120 patients will be randomized to one of two treatment arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: bevacizumab, Drug: carboplatin, Drug: paclitaxel, Drug: PRO95780 |
| 2 | Placebo comparator | Drug: bevacizumab, Drug: carboplatin, Drug: paclitaxel, Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ability to understand and willingness to sign a written informed consent
- Histologically or cytologically confirmed NSCLC
- Advanced NSCLC
- Measurable disease
- ECOG performance status of 0 or 1
Key exclusion criteria (17 listed)
- Squamous cell histology
- Prior malignancy other than NSCLC (except in situ basal cell carcinoma or in situ cervical cancer), unless it has been treated with curative intent and there is no evidence of disease for ≥ 3 years prior to randomization
- Untreated or unstable CNS metastases
- Myocardial infarction or an unstable or uncontrolled disease or condition related to or impacting cardiac function within 1 year prior to randomization
- Uncontrolled hypertension
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 |
|---|---|---|
| bevacizumabIntravenous repeating dose | Drug | 1, 2 |
| carboplatinIntravenous repeating dose | Drug | 1, 2 |
| paclitaxelIntravenous repeating dose | Drug | 1, 2 |
| placeboIntravenous repeating dose | Drug | 2 |
| PRO95780Intravenous repeating dose | Drug | 1 |
Primary outcome
Adverse events
Time frame: Length of study
Changes in vital signs, physical findings, and clinical laboratory results during and following PRO95780 administration
Time frame: Length of study
Progression-free survival, as determined by independent review facility
Time frame: Length of study
4 secondary outcomes
Objective response and duration of response, as determined by independent review facility
Time frame: Length of study
Overall survival
Time frame: 24 months
Progression-free survival, objective response, and duration of objective response, as determined by the investigator
Time frame: Length of study
Pharmacokinetic parameters
Time frame: Length of study
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 18 May 2017.
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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.
Gordon Bray, M.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bevacizumab, carboplatin and paclitaxel in people with Non-Small Cell Lung Cancer, run by Genentech, Inc..
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 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: finished, as of the sponsor's last update on 18 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 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?
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?
Adverse events (time frame: Length of study). The study lists 3 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 18 May 2017.