Advanced Renal Cell CarcinomaPhase 2NCT00467025
AMG 386, 20060159 Phase 2, RCC 1st Line in Combination With Sorafenib
A Phase 2 study testing AMG 386 and Sorafenib in people with Advanced Renal Cell Carcinoma, run by Amgen.
Trial summary
This is a phase 2, randomized, double-blind, placebo controlled, multi-center study to estimate the improvement in progression free survival (PFS) and evaluate the safety and tolerability of AMG 386 in combination with sorafenib in the treatment of subjects with advanced clear cell carcinoma of the kidney. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Renal Cell Carcinoma
- What is being tested?
- AMG 386 and Sorafenib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Jun 2014
- 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
- Subjects must have a histologically confirmed metastatic RCC with a clear cell component
- Low or intermediate risk according to the Memorial Sloan Kettering Cancer Center (MSKCC) prognostic risk classification.
- Measurable disease with at least one unidimensionally measurable lesion per RECIST guidelines with modifications
- Adequate organ and hematological function as evidenced by laboratory studies conducted at Screening.
- ECOG of 0 or 1
Who cannot join
- Disease Related
- Known history of central nervous system metastases.
- Previous treatment (excluding surgery and palliative radiotherapy) for advanced or metastatic renal cell carcinoma
- Focal radiation therapy for palliation of pain from bony metastases within 14 days of randomization.
- Medications
- Currently or previously treated with inhibitors of VEGF.
Show all 16Show fewer
- Currently or previously treated with inhibitors of angiopoietin or Tie2.
- Currently or previously treated with bevacizumab.
- General Medical
- Diagnosis of acute pancreatitis.
- Myocardial infarction, cerebrovascular accident, transient ischemic attack, percutaneous transluminal coronary angioplasty/stent, congestive heart failure, grade 2 or greater peripheral vascular disease, arrhythmias not controlled by outpatient medication, or unstable angina within 1 year prior to randomization
- Major surgery within 30 days before randomization or still recovering from prior surgery
- Uncontrolled hypertension as defined as diastolic > 90 mmHg OR systolic >150 mmHg. Anti-hypertensive medications are permitted.
- Other
- Other investigational procedures are excluded
- Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
About this study
Official title: A Randomized, Double Blinded, Multi-Center Phase 2 Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Sorafenib in Combination With AMG 386 or Placebo In Subjects With Metastatic Clear Cell Carcinoma of the Kidney
This is a phase 2, randomized, double-blind, placebo controlled, multi-center study to estimate the improvement in progression free survival (PFS) and evaluate the safety and tolerability of AMG 386 in combination with sorafenib in the treatment of subjects with advanced clear cell carcinoma of the kidney.
- Conditions
- Advanced Renal Cell Carcinoma
- Being tested
- AMG 386, Sorafenib, AMG 386 placebo IV
- Keywords
- Metastatic clear cell carcinoma of the kidney, RCC
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 386Drug
3 mg/kg or 10mg/kg IV weekly until unacceptable toxicity or disease progression
SorafenibDrug
400 mg PO BID
AMG 386 placebo IVDrug
AMG 386 placebo IV
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: AMG 386; Drug: Sorafenib; Drug: AMG 386 placebo IV |
| Arm B | Experimental | Not described Receives: Drug: AMG 386; Drug: Sorafenib |
| Arm C | Active comparator | Not described Receives: Drug: Sorafenib; Drug: AMG 386 placebo IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: 2 3/4 years
Secondary outcomes (6)
Objective response rate (ORR)
Measured: 2 3/4 years
Duration of response (DOR)
Measured: 2 3/4 years
Change in continuous measures of tumor burden
Measured: 2 3/4 years
Time-adjusted area under the curve (AUC) for the FACT-Kidney Cancer Symptom Index (FKSI-15) scale score from baseline through disease progression with imputation for missing data
Measured: 2 3/4 years
Incidence of AEs and significant laboratory changes
Measured: 2 3/4 years
Incidence of the occurrence of anti-AMG 386 antibody formation
Measured: 2 3/4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startMay 2007
- Primary completionApr 2010
- Study completionJun 2014
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 Renal Cell CarcinomaStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467025
- Sponsor's protocol ID
- 20060159
- Status last verified
- Feb 2016
- First submitted
- 26 Apr 2007
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Rini B, Szczylik C, Tannir NM, Koralewski P, Tomczak P, Deptala A, Dirix LY, Fishman M, Ramlau R, Ravaud A, Rogowski W, Kracht K, Sun YN, Bass MB, Puhlmann M, Escudier B. AMG 386 in combination with sorafenib in patients with metastatic clear cell carcinoma of the kidney: a randomized, double-blind, placebo-controlled, phase 2 study. Cancer. 2012 Dec 15;118(24):6152-61. doi: 10.1002/cncr.27632. Epub 2012 Jun 12.
PubMed 22692704
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blinded, Multi-Center Phase 2 Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Sorafenib in Combination With AMG 386 or Placebo In Subjects With Metastatic Clear Cell Carcinoma of the Kidney
- ClinicalTrials.gov ID
- NCT00467025
- Acronym / sponsor ID
- 20060159
- Conditions
- Advanced Renal Cell Carcinoma
- Keywords
- Metastatic clear cell carcinoma of the kidney, RCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 Apr 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 phase 2, randomized, double-blind, placebo controlled, multi-center study to estimate the improvement in progression free survival (PFS) and evaluate the safety and tolerability of AMG 386 in combination with sorafenib in the treatment of subjects with advanced clear cell carcinoma of the kidney.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: AMG 386, Drug: Sorafenib, Drug: AMG 386 placebo IV |
| Arm B | Experimental | Drug: AMG 386, Drug: Sorafenib |
| Arm C | Active comparator | Drug: Sorafenib, Drug: AMG 386 placebo IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must have a histologically confirmed metastatic RCC with a clear cell component
- Low or intermediate risk according to the Memorial Sloan Kettering Cancer Center (MSKCC) prognostic risk classification.
- Measurable disease with at least one unidimensionally measurable lesion per RECIST guidelines with modifications
- Adequate organ and hematological function as evidenced by laboratory studies conducted at Screening.
- ECOG of 0 or 1
Key exclusion criteria (16 listed)
- Disease Related
- Known history of central nervous system metastases.
- Previous treatment (excluding surgery and palliative radiotherapy) for advanced or metastatic renal cell carcinoma
- Focal radiation therapy for palliation of pain from bony metastases within 14 days of randomization.
- Medications
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 |
|---|---|---|
| AMG 3863 mg/kg or 10mg/kg IV weekly until unacceptable toxicity or disease progression | Drug | Arm A, Arm B |
| Sorafenib400 mg PO BID | Drug | Arm A, Arm B, Arm C |
| AMG 386 placebo IVAMG 386 placebo IV | Drug | Arm A, Arm C |
Primary outcome
Progression Free Survival
Time frame: 2 3/4 years
6 secondary outcomes
Objective response rate (ORR)
Time frame: 2 3/4 years
Duration of response (DOR)
Time frame: 2 3/4 years
Change in continuous measures of tumor burden
Time frame: 2 3/4 years
Time-adjusted area under the curve (AUC) for the FACT-Kidney Cancer Symptom Index (FKSI-15) scale score from baseline through disease progression with imputation for missing data
Time frame: 2 3/4 years
Incidence of AEs and significant laboratory changes
Time frame: 2 3/4 years
Incidence of the occurrence of anti-AMG 386 antibody formation
Time frame: 2 3/4 years
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 23 Mar 2016.
- Derived from this study: PubMed 22692704Rini B, Szczylik C, Tannir NM, Koralewski P, Tomczak P, Deptala A, Dirix LY, Fishman M, Ramlau R, Ravaud A, Rogowski W, Kracht K, Sun YN, Bass MB, Puhlmann M, Escudier B. AMG 386 in combination with sorafenib in patients with metastatic clear cell carcinoma of the kidney: a randomized, double-blind, placebo-controlled, phase 2 study. Cancer. 2012 Dec 15;118(24):6152-61. doi: 10.1002/cncr.27632. Epub 2012 Jun 12.
- 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 AMG 386 and Sorafenib in people with Advanced Renal Cell Carcinoma, 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 5 inclusion and 16 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 23 Mar 2016. 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?
Progression Free Survival (time frame: 2 3/4 years). 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 NCT00467025, 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 23 Mar 2016.