Colorectal CancerPhase 2NCT00425204
Study for Patients Who Have Benefited and Tolerated Prior Panitumumab Treatment
A Phase 2 study testing Panitumumab (ABX-EGF) in people with Colorectal Cancer and Non-Small Cell Lung Cancer, run by Amgen.
Trial summary
A multi-center, open-label, extended treatment, clinical trial examining the safety of administering multiple does of panitumumab by intravenous (i.v.) infusion to patients who have previously received panitumumab and benefited from treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Non-Small Cell Lung Cancer, Prostate Cancer
- What is being tested?
- Panitumumab (ABX-EGF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to Mar 2008
- 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
- Able to comprehend and sign an IRB approved Informed Consent Form
- Male or female 18 years of age or older
- Female patients who are post menopausal (no menstrual period for a minimum of six months), surgically sterilized, or are using an oral or implanted contraceptive, double barrier birth control, or an intrauterine device (IUD) and have a negative serum pregnancy test upon entry into this study; or male patients willing to use contraception upon enrollment and during the course of the study
- Previously received and tolerated panitumumab treatment on studies 20020374 Part 2 or 20030138/20040116
- Is considered "stable" or "responding" based on the RECIST (20020374 Part 2) or WHO (20040116) criteria, at the final treatment visit of the previous panitumumab clinical trial and the screening visit for this study
- No more than 2 months (60 days) have elapsed since the final treatment visit of the previous panitumumab clinical trial
- Karnofsky score > or = 70%
Who cannot join
- Brain metastases (20040116 patients are allowed only if controlled and asymptomatic)
- Uncontrolled hypercalcemia (calcium level outside the upper limit of normal; antihypercalcemic treatment is allowed). Exception: Patients in the Motzer Intermediate Risk Group from 20020374 Cohort 2 with uncontrolled high corrected calcium (>10 mg/dl) may be enrolled
- Use of any anti-tumor therapy or investigational drug, other than panitumumab, between the last visit of the previous panitumumab study and the initial visit in this 20020375 study
- Prior treatment with another anti-EGFr agent, other than panitumumab
- Myocardial infarction within 1 year prior to entering the study
- Has other cancer that has been active and required treatment within the past 5 years (basal cell carcinoma or cervical carcinoma in situ are allowed)
Show all 12Show fewer
- Pregnant or breast feeding female; female of childbearing potential (defined as: post menarche and is biologically capable of becoming pregnant) unwilling to use birth control (as defined in the inclusion criteria) during and for 6 months following treatment
- Male patient unwilling to use birth control (as defined in the inclusion criteria) during and for 1 month following treatment
- Known to be HIV positive
- History of any chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the Investigator may increase the risks associated with study drug administration
- Allergy to the ingredients of the study medication or to Staphylococcus Protein A
- History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis
About this study
Official title: A Multi-Center, Open-Label Clinical Trial To Determine The Safety of ABX-EGF As Continued Treatment For Patients Who Have Benefited From and Tolerated Prior ABX-EGF Treatment
A multi-center, open-label, extended treatment, clinical trial examining the safety of administering multiple does of panitumumab by intravenous (i.v.) infusion to patients who have previously received panitumumab and benefited from treatment
- Conditions
- Colorectal Cancer, Non-Small Cell Lung Cancer, Prostate Cancer, Solid Tumors, Advanced Renal Cell Carcinoma
- Being tested
- Panitumumab (ABX-EGF)
- Medical subject headings
- Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panitumumab (ABX-EGF)Drug
Dose received in previous studies will be rolled over to this study. These regimens include: 2.5 mg/kg weekly; 6.0 mg/kg every 2 weeks; and 9.0 mg/kg every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Experimental | Dose received in previous studies will be rolled over to this study. These regimens include: 2.5 mg/kg weekly; 6.0 mg/kg every 2 weeks; and 9.0 mg/kg every 3 weeks. Receives: Drug: Panitumumab (ABX-EGF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide continued, extended panitumumab treatment to subjects who appeared to have benefited from and tolerated previous panitumumab treatment in Studies 20020374 Part 2 or 20030138 and its extension study, 20040116
Measured: Until disease progression, an AE or withdrawn consent
Secondary outcomes (1)
To assess the safety of multidose administration of panitumumab in subjects who received continued and extended panitumumab treatment
Measured: Until disease progression, an AE or withdrawn consent
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 startMar 2004
- Primary completionSep 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00425204
- Sponsor's protocol ID
- 20020375
- Other IDs
- Abgenix Protocol No. ABX-0311
- Status last verified
- Sep 2008
- First submitted
- 18 Jan 2007
- Last updated
- 15 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label Clinical Trial To Determine The Safety of ABX-EGF As Continued Treatment For Patients Who Have Benefited From and Tolerated Prior ABX-EGF Treatment
- ClinicalTrials.gov ID
- NCT00425204
- Acronym / sponsor ID
- 20020375
- Conditions
- Colorectal Cancer, Non-Small Cell Lung Cancer, Prostate Cancer, Solid Tumors, Advanced Renal Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 22 Jan 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.
A multi-center, open-label, extended treatment, clinical trial examining the safety of administering multiple does of panitumumab by intravenous (i.v.) infusion to patients who have previously received panitumumab and benefited from treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label | Experimental | Drug: Panitumumab (ABX-EGF)Dose received in previous studies will be rolled over to this study. These regimens include: 2.5 mg/kg weekly; 6.0 mg/kg every 2 weeks; and 9.0 mg/kg every 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to comprehend and sign an IRB approved Informed Consent Form
- Male or female 18 years of age or older
- Female patients who are post menopausal (no menstrual period for a minimum of six months), surgically sterilized, or are using an oral or implanted contraceptive, double barrier birth control, or an intrauterine device (IUD) and have a negative serum pregnancy test upon entry into this study; or male patients willing to use contraception upon enrollment and during the course of the study
- Previously received and tolerated panitumumab treatment on studies 20020374 Part 2 or 20030138/20040116
- Is considered "stable" or "responding" based on the RECIST (20020374 Part 2) or WHO (20040116) criteria, at the final treatment visit of the previous panitumumab clinical trial and the screening visit for this study
Key exclusion criteria (12 listed)
- Brain metastases (20040116 patients are allowed only if controlled and asymptomatic)
- Uncontrolled hypercalcemia (calcium level outside the upper limit of normal; antihypercalcemic treatment is allowed). Exception: Patients in the Motzer Intermediate Risk Group from 20020374 Cohort 2 with uncontrolled high corrected calcium (>10 mg/dl) may be enrolled
- Use of any anti-tumor therapy or investigational drug, other than panitumumab, between the last visit of the previous panitumumab study and the initial visit in this 20020375 study
- Prior treatment with another anti-EGFr agent, other than panitumumab
- Myocardial infarction within 1 year prior to entering the study
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 |
|---|---|---|
| Panitumumab (ABX-EGF)Dose received in previous studies will be rolled over to this study. These regimens include: 2.5 mg/kg weekly; 6.0 mg/kg every 2 weeks; and 9.0 mg/kg every 3 weeks. | Drug | Open Label |
Primary outcome
To provide continued, extended panitumumab treatment to subjects who appeared to have benefited from and tolerated previous panitumumab treatment in Studies 20020374 Part 2 or 20030138 and its extension study, 20040116
Time frame: Until disease progression, an AE or withdrawn consent
1 secondary outcome
To assess the safety of multidose administration of panitumumab in subjects who received continued and extended panitumumab treatment
Time frame: Until disease progression, an AE or withdrawn consent
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 15 Sep 2008.
- FDA-approved Drug LabelingLink provided by the sponsor.
- AmgenTrials clinical trials websiteLink 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.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Panitumumab (ABX-EGF) in people with Colorectal Cancer and Non-Small Cell Lung Cancer, run by Amgen.
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 12 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 15 Sep 2008. 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. 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?
To provide continued, extended panitumumab treatment to subjects who appeared to have benefited from and tolerated previous panitumumab treatment in Studies 20020374 Part 2 or 20030138 and its extension study, 20040116 (time frame: Until disease progression, an AE or withdrawn consent). 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 15 Sep 2008.