Carcinoma, Non-Small-Cell LungPhase 2NCT00049790
Safety and Efficacy Study of rhAngiostatin Administered in Combination With Paclitaxel and Carboplatin to Patients With Non-Small-Cell Lung Cancer
A Phase 2 study testing recombinant human Angiostatin protein, paclitaxel and carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by CASI pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of rhAngiostatin protein administered in combination with paclitaxel and carboplatin to patients with non-small-cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- recombinant human Angiostatin protein, paclitaxel and carboplatin
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento Dec 2004
- 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
- Histological or cytological confirmed Stage IIIB NSCLC with malignant pleural effusions, or Stage IV NSCLC or recurrent NSCLC
- No previous chemotherapy for NSCLC
- Have one lesion that is bidimensionally measurable by physical exam, MRI, or CT greater than 1 cm in diameter
- Specified lab parameters
- Life expectancy of at least 12 weeks
- ECOG performance status of 0 or 1
- Understand requirements of study
- Agree to use effective contraceptive methods
Who cannot join
- Have CNS metastases
- Have any active cancer in addition ot NSCLC
- Participated in clinical trial involving conventional or investigational drugs within previous 4 weeks
- Have any contraindication to paclitaxel or carboplatin
- Have had Grade 3 or greater peripheral neuropathies
- Be pregnant or lactating
Show all 14Show fewer
- Have a history of myocardial infarction or angina pectoris/angina in the last 6 months
- Have had significant (30 mL or more) hemoptysis with the past 3 months
- Have an active infection
- Have a history of bleeding diathesis, hypercoagulable condition, or an active bleeding disorder
- Be receiving concurrent treatment with therapeutic doses of heparin or coumadin
- Have had major surgery within 4 weeks of stating therapy
- Have additional uncontrolled serious medical conditions or psychiatric illness
- Received rhAngiostatin in other clinical protocols
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana Cancer Pavilion, Indiana University
Indianapolis, Indiana, 46202
About this study
The purpose of this study is to determine the safety and efficacy of rhAngiostatin protein administered in combination with paclitaxel and carboplatin to patients with non-small-cell lung cancer.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- recombinant human Angiostatin protein, paclitaxel, carboplatin
- Keywords
- Advanced 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.
recombinant human Angiostatin proteinDrug
paclitaxelDrug
carboplatinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2002 (estimated)
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- CASI pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00049790
- Sponsor's protocol ID
- ANG-CL-004
- Status last verified
- Jan 2009
- First submitted
- 13 Nov 2002
- Last updated
- 9 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of rhAngiostatin Administered in Combination With Paclitaxel and Carboplatin to Patients With Non-Small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00049790
- Acronym / sponsor ID
- ANG-CL-004
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Advanced non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- CASI pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study completion
- Dec 2004
- First posted
- 15 Nov 2002 (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.
The purpose of this study is to determine the safety and efficacy of rhAngiostatin protein administered in combination with paclitaxel and carboplatin to patients with non-small-cell lung cancer.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histological or cytological confirmed Stage IIIB NSCLC with malignant pleural effusions, or Stage IV NSCLC or recurrent NSCLC
- No previous chemotherapy for NSCLC
- Have one lesion that is bidimensionally measurable by physical exam, MRI, or CT greater than 1 cm in diameter
- Specified lab parameters
- Life expectancy of at least 12 weeks
Key exclusion criteria (14 listed)
- Have CNS metastases
- Have any active cancer in addition ot NSCLC
- Participated in clinical trial involving conventional or investigational drugs within previous 4 weeks
- Have any contraindication to paclitaxel or carboplatin
- Have had Grade 3 or greater peripheral neuropathies
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 |
|---|---|---|
| recombinant human Angiostatin protein | Drug | – |
| paclitaxel | Drug | – |
| carboplatin | Drug | – |
Primary outcome
Not reported in the source record.
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 9 Jan 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing recombinant human Angiostatin protein, paclitaxel and carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by CASI pharmaceuticals, Inc. 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 8 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 9 Jan 2009. 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 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.
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 9 Jan 2009.