Malignant Solid TumourPhase 1NCT00969410
A Pharmacodynamic Study of AV-299 (Formerly SCH 900105) in Subjects With Advanced Solid Tumors Who Have Liver Metastases
A Phase 1 study testing AV-299 in people with Malignant Solid Tumour and Liver Metastases, run by AVEO Pharmaceuticals, Inc. at 1 site in Spain.
Trial summary
A pharmacodynamic study to evaluate the effect of AV-299 on exploratory pharmacodynamic markers in subjects with advanced solid tumors who have liver metastases. To evaluate safety and tolerability of AV-299 administered IV in subjects with advanced solid tumors who have liver metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Tumour, Liver Metastases
- What is being tested?
- AV-299
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2009to Mar 2011
- 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
- Ability to give written informed consent and be able to adhere to dose and visit schedules.
- Diagnosis of an advanced colorectal, breast, gastric/esophageal or pancreatic cancer with liver metastases that are amenable to biopsy.
- Histological or cytological evidence of malignancy.
- Advanced metastatic colorectal, breast, gastric/esophageal or pancreatic cancer that has recurred or progressed following standard therapy or failed standard therapy; or for which no standard therapy currently exists, or for which subject is not a candidate for, or is unwilling to undergo standard therapy.
- Note: Additional tumor histologies may be eligible based on available HGF/c-Met pathway data and approval by the Sponsor.
- Disease that is currently not amenable to curative surgical intervention.
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- Male or female and ≥ 18 years of age.
- ECOG performance status of 0-1.
- Measurable p-Met by immunohistochemistry in archived or otherwise available tumor sample.
- Female subjects of childbearing potential must have negative pregnancy test within 5 days prior to first dose of study drug.
- Female subjects of childbearing potential and male subjects whose sexual partners are of childbearing potential must agree to abstain from sexual intercourse or to use an effective method of contraception during the study and for 60 days after the last dose of AV-299 (formerly SCH 900105). Examples of effective methods of contraception include oral contraceptives or double barrier methods such as condom plus spermicide or condom plus diaphragm.
- Adequate hematologic function as evidenced by Hg ≥ 9g/dL, WBC ≥ 3000 per mm3, ANC ≥ 1500 per mm3 and platelet count ≥ 100,000 per mm3.
- Adequate hepatic function as evidenced by a serum bilirubin level ≤ 1.5 × ULN (except with known Gilbert's Syndrome) and with serum AST/ALT levels ≤ 5 × ULN.
- Adequate renal function as evidenced by a serum creatinine level ≤ 1.5 × ULN or a calculated creatinine clearance > 60 mL/min.
- Adequate coagulation function as evidenced by PTT ≤ 1.5 × ULN and INR ≤ 1.5 × ULN.
- Recovery from the effects of any prior surgery, radiotherapy, or systemic antineoplastic therapy.
- Subjects with abnormal liver function tests (LFTs) who have not been screened for Hepatitis B or C within the past 6 months prior to study enrollment, will need to be screened for Hepatitis B and C and can only be enrolled if the screening is negative.
Who cannot join
- Women who are breast-feeding, pregnant, or intend to become pregnant.
- Hematologic malignancies.
- Any of the following within 6 months prior to administration of study drug:
- Myocardial infarction (MI), severe/unstable angina pectoris, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or seizure disorder.
- Serious/symptomatic active infection, or infection requiring antibiotics, within 14 days prior to first dose of study drug.
- Persistent, unresolved CTCAE v3.0 Grade 2 or higher drug-related toxicity (except alopecia, erectile dysfunction, hot flashes, decreased libido, and Grade 2 sensory peripheral neuropathy) associated with previous treatment.
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- Inadequate recovery from any prior surgical procedure or major surgical procedure performed within 4 weeks prior to administration of first dose of study drug.
- Any other medical or psychiatric condition that, in the opinion of the investigator, might interfere with the subject's participation in the trial or interfere with the interpretation of trial results.
- Known Human Immunodeficiency Virus (HIV) infection or a known HIV-related malignancy.
- Known active hepatitis B or C.
- Known hypersensitivity to any of the components of SCH 900105.
- Known bleeding diathesis.
- Radiotherapy within 3 weeks prior to first study drug administration.
- Inability to comply with the protocol requirements, including inability to undergo liver biopsies.
- Participation in any other clinical trials involving therapeutic agents.
- Any medications prohibited in the study.
- Active alcohol or illicit drug abuse.
- Stem cell/bone marrow transplant within 6 months of first dose of study drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pharmacodynamic Study of AV-299 (Formerly SCH 900105) in Subjects With Advanced Solid Tumors Who Have Liver Metastases (P05670)
A pharmacodynamic study to evaluate the effect of AV-299 on exploratory pharmacodynamic markers in subjects with advanced solid tumors who have liver metastases.
To evaluate safety and tolerability of AV-299 administered IV in subjects with advanced solid tumors who have liver metastases.
- Conditions
- Malignant Solid Tumour, Liver Metastases
- Being tested
- AV-299
- Keywords
- Neoplasms, Neoplasm metastasis, Liver neoplasms, Neoplastic processes, Pathologic processes, Digestive system neoplasms, Neoplasms by site, Digestive system diseases, Liver diseases
- Medical subject headings
- Neoplasms, Neoplasm Metastasis, Liver Neoplasms, Neoplastic Processes, Pathologic Processes, Digestive System Neoplasms, Neoplasms by Site, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV-299Biological
Also called Ficlatuzumab, Formerly SCH900105
AV-299 will be given as an intravenous infusion in dose-escalating doses of 2, 10, and 20 mg/kg once every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| AV-299 administered IV (monotherapy) | Experimental | Subjects will be enrolled sequentially and treated with AV-299 (formerly SCH 900105) in dose escalating cohorts. Accrual to the next cohort will occur only if <= 1 out of 6 subjects experiences a dose-limiting toxicity (DLT) during the first 2 cycles. If >= 2 subjects in the same dose cohort experience a DLT during the first 2 cycles, dose-escalation will be terminated. Receives: Biological: AV-299 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of AV-299 (formerly SCH 900105) on exploratory pharmacodynamic markers in subjects with advanced solid tumors who have liver metastases
Peripheral blood analysis, liver tissue analysis, and PET
Measured: Screening Cycle 1: Day 1, Day 3-4: Cycle 2: Day 1 Cycle 3: Day 8-14
To evaluate safety and tolerability of AV-299 (formerly SCH 900105) administered IV in subjects with advanced solid tumors who have liver metastases
Dose-limiting toxicities.
Measured: DLTs assessed during first 4 weeks of treatment.
Secondary outcomes (3)
To evaluate the PK of AV-299 (formerly SCH 900105) in subjects with advanced solid tumors who have liver metastases
Measured: Cycle 1: Day 1, Day 3-4 Cycle 2: Day 1 Cycle 3: Day 1, Day 8-14
To study the preliminary antineoplastic activity of AV-299 (formerly SCH 900105) in subjects with advanced solid tumors who have liver metastases
Measured: Subjects will undergo disease assessment at screening (within 4 weeks prior to first dose of study drug), the Cycle 3 Day 8-14 visit, and approximately every 6 weeks thereafter.
To investigate the effect of AV-299 (formerly SCH 900105) on gene expression patterns in peripheral blood mononuclear cells and liver biopsies in subjects with advanced solid tumors who have liver metastases
Measured: Cycle 1: Day 1, Day 3-4 Cycle 3: Day 8-14:
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumourStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- AVEO Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shefali Agarwal, MD, Study director, AVEO Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969410
- Sponsor's protocol ID
- P05670
- Status last verified
- Apr 2012
- First submitted
- 31 Aug 2009
- Last updated
- 12 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacodynamic Study of AV-299 (Formerly SCH 900105) in Subjects With Advanced Solid Tumors Who Have Liver Metastases (P05670)
- ClinicalTrials.gov ID
- NCT00969410
- Acronym / sponsor ID
- P05670
- Conditions
- Malignant Solid Tumour, Liver Metastases
- Keywords
- Neoplasms, Neoplasm metastasis, Liver neoplasms, Neoplastic processes, Pathologic processes, Digestive system neoplasms, Neoplasms by site, Digestive system diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- AVEO Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 1 Sep 2009 (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 pharmacodynamic study to evaluate the effect of AV-299 on exploratory pharmacodynamic markers in subjects with advanced solid tumors who have liver metastases.
To evaluate safety and tolerability of AV-299 administered IV in subjects with advanced solid tumors who have liver metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AV-299 administered IV (monotherapy) | Experimental | Biological: AV-299Subjects will be enrolled sequentially and treated with AV-299 (formerly SCH 900105) in dose escalating cohorts. Accrual to the next cohort will occur only if <= 1 out of 6 subjects experiences a dose-limiting toxicity (DLT) during the first 2 cycles. If >= 2 subjects in the same dose cohort experience a DLT during the first 2 cycles, dose-escalation will be terminated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Ability to give written informed consent and be able to adhere to dose and visit schedules.
- Diagnosis of an advanced colorectal, breast, gastric/esophageal or pancreatic cancer with liver metastases that are amenable to biopsy.
- Histological or cytological evidence of malignancy.
- Advanced metastatic colorectal, breast, gastric/esophageal or pancreatic cancer that has recurred or progressed following standard therapy or failed standard therapy; or for which no standard therapy currently exists, or for which subject is not a candidate for, or is unwilling to undergo standard therapy.
- Note: Additional tumor histologies may be eligible based on available HGF/c-Met pathway data and approval by the Sponsor.
Key exclusion criteria (18 listed)
- Women who are breast-feeding, pregnant, or intend to become pregnant.
- Hematologic malignancies.
- Any of the following within 6 months prior to administration of study drug:
- Myocardial infarction (MI), severe/unstable angina pectoris, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or seizure disorder.
- Serious/symptomatic active infection, or infection requiring antibiotics, within 14 days prior to first dose of study drug.
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 |
|---|---|---|
| AV-299Also: Ficlatuzumab, Formerly SCH900105AV-299 will be given as an intravenous infusion in dose-escalating doses of 2, 10, and 20 mg/kg once every 2 weeks. | Biological | AV-299 administered IV (monotherapy) |
Primary outcome
To evaluate the effect of AV-299 (formerly SCH 900105) on exploratory pharmacodynamic markers in subjects with advanced solid tumors who have liver metastases
Time frame: Screening Cycle 1: Day 1, Day 3-4: Cycle 2: Day 1 Cycle 3: Day 8-14
Peripheral blood analysis, liver tissue analysis, and PET
To evaluate safety and tolerability of AV-299 (formerly SCH 900105) administered IV in subjects with advanced solid tumors who have liver metastases
Time frame: DLTs assessed during first 4 weeks of treatment.
Dose-limiting toxicities.
3 secondary outcomes
To evaluate the PK of AV-299 (formerly SCH 900105) in subjects with advanced solid tumors who have liver metastases
Time frame: Cycle 1: Day 1, Day 3-4 Cycle 2: Day 1 Cycle 3: Day 1, Day 8-14
To study the preliminary antineoplastic activity of AV-299 (formerly SCH 900105) in subjects with advanced solid tumors who have liver metastases
Time frame: Subjects will undergo disease assessment at screening (within 4 weeks prior to first dose of study drug), the Cycle 3 Day 8-14 visit, and approximately every 6 weeks thereafter.
To investigate the effect of AV-299 (formerly SCH 900105) on gene expression patterns in peripheral blood mononuclear cells and liver biopsies in subjects with advanced solid tumors who have liver metastases
Time frame: Cycle 1: Day 1, Day 3-4 Cycle 3: Day 8-14:
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 12 Apr 2012.
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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.
Shefali Agarwal, MD study director
AVEO Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AV-299 in people with Malignant Solid Tumour and Liver Metastases, run by AVEO Pharmaceuticals, Inc. at 1 site in Spain.
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 17 inclusion and 18 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 12 Apr 2012. 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 Spain. 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 effect of AV-299 (formerly SCH 900105) on exploratory pharmacodynamic markers in subjects with advanced solid tumors who have liver metastases (time frame: Screening Cycle 1: Day 1, Day 3-4: Cycle 2: Day 1 Cycle 3: Day 8-14). 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?
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 12 Apr 2012.