Advanced Solid TumorsPhase 1NCT00730470
Phase I Study of U3P1287/01, Including Patients With Advanced Solid Tumors
A Phase 1 study testing U3-1287 (AMG888) in people with Advanced Solid Tumors, run by U3 Pharma GmbH at 6 sites in United States.
Trial summary
This is a Phase 1 clinical study to investigate the safety, pharmacokinetics, and pharmacodynamics of U3-1287 (AMG 888), a fully human monoclonal antibody targeting the HER3 receptor, in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- U3-1287 (AMG888)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2008to Jul 2010
- 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
- Pathologically or cytologically documented advanced solid tumor that is refractory to standard treatment, for which no standard therapy is available, or the patient refuses standard therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Men or women at least 18 years of age
- Adequate hematologic, cardiac, renal, hepatic, metabolic, and coagulation function
Who cannot join
- Presence of untreated or symptomatic brain metastasis.
- Presence of ascites or pleural effusion requiring chronic medical intervention.
- Uncontrolled hypertension
- Concurrent or previous (within 1 week of study day 1) anticoagulation therapy, except low-dose warfarin (≤ 2 mg/day) or low dose,low molecular weight heparin for prophylaxis against central venous catheter thrombosis.
- Recent major surgical procedure or not yet recovered from major surgery
- Recent participation in clinical drug trials.
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- Participation in other investigational procedures.
- Unresolved toxicities from prior anti-cancer therapy
- Patient who is pregnant (e.g. positive human choriogonadotropin [HCG] test) or nursing.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Dana Faber Cancer Institute
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02115
Karmanos Cancer Institute
Detroit, Michigan, 48201
Vanderbilt Ingram cancer Centre
Nashville, Tennessee, 37232
Memorial Sloan-Kettering Cancer Centre
New York, New York, 10065
Northwest Medical Specialties
Tacoma, Washington, 98405
About this study
Official title: A Phase I, Open-label, Dose-Finding Study to Assess the Safety and Tolerability of U3-1287 (AMG 888), a Human Monoclonal Antibody Targeting HER3 in Patients With Advanced Solid Tumors.
This is a Phase 1 clinical study to investigate the safety, pharmacokinetics, and pharmacodynamics of U3-1287 (AMG 888), a fully human monoclonal antibody targeting the HER3 receptor, in patients with advanced solid tumors. Eligible patients will have disease that is refractory or resistant to standard treatments or for which no standard therapy exists. The study will be conducted in two parts; a dose escalation (Part 1) and a dose expansion (Part 2). The hypothesis for this study is that U3-1287 (AMG888) will be safe and well tolerated in patients with advanced solid tumors and will show initial evidence of anti-tumor activity.
- Conditions
- Advanced Solid Tumors
- Being tested
- U3-1287 (AMG888)
- Keywords
- Human Epidermal Growth Factor Receptor 3, HER3, Heregulin, erb B3, Solid Tumors, Phase I Clinical Study
- Medical subject headings
- Lethal Congenital Contracture Syndrome 2, Fibromatosis, Gingival, 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U3-1287 (AMG888)Drug
IV Infusion Dose Escalation (Part 1) - 5 Dose Cohorts Dose Expansion (Part 2) - 30 patients
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: U3-1287 (AMG888) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of U3-1287 (AMG888) in patients with advanced solid tumors
Measured: Lenth of study
To evaluate maximum tolerated dose (MTD) of U3-1287(AMG888) when administered intravenously to patients with advanced solid tumors
Measured: Lenth of study
Secondary outcomes (3)
Pharmacokinetic Parameters
Measured: Length of study
Pharmacodynamic Parameters
Measured: Length of study
Human anti-human antibody profile for U3-1287(AMG888)
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 posted8 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- U3 Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730470
- Sponsor's protocol ID
- U3P1287/01
- Status last verified
- Jul 2010
- First submitted
- 7 Aug 2008
- Last updated
- 29 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
LoRusso P, Janne PA, Oliveira M, Rizvi N, Malburg L, Keedy V, Yee L, Copigneaux C, Hettmann T, Wu CY, Ang A, Halim AB, Beckman RA, Beaupre D, Berlin J. Phase I study of U3-1287, a fully human anti-HER3 monoclonal antibody, in patients with advanced solid tumors. Clin Cancer Res. 2013 Jun 1;19(11):3078-87. doi: 10.1158/1078-0432.CCR-12-3051. Epub 2013 Apr 16.
PubMed 23591447
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Dose-Finding Study to Assess the Safety and Tolerability of U3-1287 (AMG 888), a Human Monoclonal Antibody Targeting HER3 in Patients With Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT00730470
- Acronym / sponsor ID
- U3P1287/01
- Conditions
- Advanced Solid Tumors
- Keywords
- Human Epidermal Growth Factor Receptor 3, HER3, Heregulin, erb B3, Solid Tumors, Phase I Clinical Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- U3 Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 8 Aug 2008 (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 Phase 1 clinical study to investigate the safety, pharmacokinetics, and pharmacodynamics of U3-1287 (AMG 888), a fully human monoclonal antibody targeting the HER3 receptor, in patients with advanced solid tumors. Eligible patients will have disease that is refractory or resistant to standard treatments or for which no standard therapy exists. The study will be conducted in two parts; a dose escalation (Part 1) and a dose expansion (Part 2). The hypothesis for this study is that U3-1287 (AMG888) will be safe and well tolerated in patients with advanced solid tumors and will show initial evidence of anti-tumor activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: U3-1287 (AMG888) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pathologically or cytologically documented advanced solid tumor that is refractory to standard treatment, for which no standard therapy is available, or the patient refuses standard therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Men or women at least 18 years of age
- Adequate hematologic, cardiac, renal, hepatic, metabolic, and coagulation function
Key exclusion criteria (9 listed)
- Presence of untreated or symptomatic brain metastasis.
- Presence of ascites or pleural effusion requiring chronic medical intervention.
- Uncontrolled hypertension
- Concurrent or previous (within 1 week of study day 1) anticoagulation therapy, except low-dose warfarin (≤ 2 mg/day) or low dose,low molecular weight heparin for prophylaxis against central venous catheter thrombosis.
- Recent major surgical procedure or not yet recovered from major surgery
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 |
|---|---|---|
| U3-1287 (AMG888)IV Infusion Dose Escalation (Part 1) - 5 Dose Cohorts Dose Expansion (Part 2) - 30 patients | Drug | 1 |
Primary outcome
To evaluate the safety and tolerability of U3-1287 (AMG888) in patients with advanced solid tumors
Time frame: Lenth of study
To evaluate maximum tolerated dose (MTD) of U3-1287(AMG888) when administered intravenously to patients with advanced solid tumors
Time frame: Lenth of study
3 secondary outcomes
Pharmacokinetic Parameters
Time frame: Length of study
Pharmacodynamic Parameters
Time frame: Length of study
Human anti-human antibody profile for U3-1287(AMG888)
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 29 Jul 2010.
- Derived from this study: PubMed 23591447LoRusso P, Janne PA, Oliveira M, Rizvi N, Malburg L, Keedy V, Yee L, Copigneaux C, Hettmann T, Wu CY, Ang A, Halim AB, Beckman RA, Beaupre D, Berlin J. Phase I study of U3-1287, a fully human anti-HER3 monoclonal antibody, in patients with advanced solid tumors. Clin Cancer Res. 2013 Jun 1;19(11):3078-87. doi: 10.1158/1078-0432.CCR-12-3051. Epub 2013 Apr 16.
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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.
6 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 U3-1287 (AMG888) in people with Advanced Solid Tumors, run by U3 Pharma GmbH at 6 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 4 inclusion and 9 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 29 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
To evaluate the safety and tolerability of U3-1287 (AMG888) in patients with advanced solid tumors (time frame: Lenth of study). The study lists 2 primary outcomes in all. 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 NCT00730470, which also lists 1 linked publication.
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 29 Jul 2010.