Locally Advanced or Metastatic, Unresectable Soft Tissue SarcomaPhase 1/2NCT00626704
Phase 1b/2 Study of AMG 655 With Doxorubicin for the First-Line Treatment of Unresectable Soft Tissue Sarcoma
A Phase 1/2 study testing AMG 655 and Doxorubicin in people with Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma and Sarcoma, run by Amgen.
Trial summary
This phase 1/2, multicenter, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with doxorubicin compared with doxorubicin alone in subjects with previously untreated, locally advanced or metastatic, unresectable soft tissue sarcoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma, Sarcoma, Soft Tissue Sarcoma
- What is being tested?
- AMG 655 and Doxorubicin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Mar 2011
- Phase
- Phase 1/2
- 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
- Histologically or cytologically confirmed soft tissue sarcoma
- Locally advanced, recurrent, or metastatic, unresectable disease
- Measurable disease according to modified RECIST
- ECOG performance status of 0 or 1
- Men or women at least 18 years of age
- Adequate hematological, renal, hepatic, and coagulation function
Who cannot join
- Prior treatment with anthracyclines
- Uncontrolled cardiovascular disease
About this study
Official title: A Phase 1b/2 Study of AMG 655 in Combination With Doxorubicin for the First-Line Treatment of Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma
This phase 1/2, multicenter, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with doxorubicin compared with doxorubicin alone in subjects with previously untreated, locally advanced or metastatic, unresectable soft tissue sarcoma.
- Conditions
- Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma, Sarcoma, Soft Tissue Sarcoma
- Being tested
- AMG 655, Placebo, Doxorubicin
- Keywords
- Sarcoma, Soft Tissue Sarcoma, Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma, AMG 655, STS, Doxorubicin, Death receptor, TRAIL receptor, Apoptosis
- Medical subject headings
- Neoplasm Metastasis, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 655Drug
Also called Conatumumab
AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).
PlaceboOther
Inactive dummy AMG 655 (to maintain blind)
DoxorubicinDrug
Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of Daunorubicin.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | AMG 655 + Doxorubicin Receives: Drug: AMG 655; Drug: Doxorubicin |
| Arm 2 | Placebo comparator | Placebo + Doxorubicin Receives: Other: Placebo; Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
Measured: Length of Study
Secondary outcomes (1)
Objective response rate, time to response, duration of response, clinical benefit rate, overall survival, incidence of adverse events and clinical laboratory abnormalities, and incidence of anti-AMG 655 antibody formation.
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 posted29 Feb 2008 (estimated)
- Study startNov 2007
- Primary completionAug 2009
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic, Unresectable Soft Tissue SarcomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 134 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
- NCT00626704
- Sponsor's protocol ID
- 20060324
- Status last verified
- Apr 2015
- First submitted
- 14 Feb 2008
- Last updated
- 25 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Study of AMG 655 in Combination With Doxorubicin for the First-Line Treatment of Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT00626704
- Acronym / sponsor ID
- 20060324
- Conditions
- Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma, Sarcoma, Soft Tissue Sarcoma
- Keywords
- Sarcoma, Soft Tissue Sarcoma, Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma, AMG 655, STS, Doxorubicin, Death receptor, TRAIL receptor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 29 Feb 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 phase 1/2, multicenter, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with doxorubicin compared with doxorubicin alone in subjects with previously untreated, locally advanced or metastatic, unresectable soft tissue sarcoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: AMG 655, Drug: DoxorubicinAMG 655 + Doxorubicin |
| Arm 2 | Placebo comparator | Other: Placebo, Drug: DoxorubicinPlacebo + Doxorubicin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed soft tissue sarcoma
- Locally advanced, recurrent, or metastatic, unresectable disease
- Measurable disease according to modified RECIST
- ECOG performance status of 0 or 1
- Men or women at least 18 years of age
Key exclusion criteria (2 listed)
- Prior treatment with anthracyclines
- Uncontrolled cardiovascular disease
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 655Also: ConatumumabAMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5). | Drug | Arm 1 |
| PlaceboInactive dummy AMG 655 (to maintain blind) | Other | Arm 2 |
| DoxorubicinAntineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of Daunorubicin. | Drug | Arm 1, Arm 2 |
Primary outcome
Progression-Free Survival
Time frame: Length of Study
1 secondary outcome
Objective response rate, time to response, duration of response, clinical benefit rate, overall survival, incidence of adverse events and clinical laboratory abnormalities, and incidence of anti-AMG 655 antibody formation.
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 25 May 2015.
- 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 1/2 study testing AMG 655 and Doxorubicin in people with Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma and Sarcoma, 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 6 inclusion and 2 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 25 May 2015. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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: Length of Study). 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 25 May 2015.