CarcinomaPhase 1NCT01016054
A Study of the Safety and Pharmacokinetics of AGS-8M4 Given in Combination With Chemotherapy in Women With Ovarian Cancer
A Phase 1 study testing AGS-8M4, Pegylated liposomal doxorubicin (PLD) and gemcitabine in people with Carcinoma and Ovarian Cancer, run by Astellas Pharma Inc at 1 site in United States.
Trial summary
This is a parallel arm study to evaluate AGS-8M4 administered in combination with chemotherapy in subjects with ovarian cancer. AGS-8M4 will be administered as an IV infusion until disease worsens. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Carcinoma, Ovarian Cancer, Ovarian Diseases
- What is being tested?
- AGS-8M4, Pegylated liposomal doxorubicin (PLD) and gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Apr 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with recurrent disease Stage III/IV diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma
- Subjects with either platinum resistant or platinum sensitive ovarian cancer
- At least 14 days of previous cytotoxic chemotherapy and have recovered from all toxicities
- Left ventricular ejection fraction (LVEF) equal to or greater than the institutional lower limit of normal as measured by echocardiogram or MUGA (ONLY required for platinum resistant patients)
Who cannot join
- Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of screening
- Use of any investigational drug within 30 days prior to screening
- Prior monoclonal antibody therapy other than Avastin
- Avastin administration within 90 days of screening
- History of thromboembolic events and bleeding disorders ≤ 3 months (e.g.,DVT or PE)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1b, Parallel Arm, Multicenter, Open-Label Study of the Safety and Pharmacokinetics of AGS-8M4 Given in Combination With Two Different Chemotherapy Regimens in Women With Platinum Resistant or Platinum Sensitive Ovarian Cancer
This is a parallel arm study to evaluate AGS-8M4 administered in combination with chemotherapy in subjects with ovarian cancer. AGS-8M4 will be administered as an IV infusion until disease worsens.
Read the detailed description
All Subjects will receive AGS-8M4 treatment. Subjects will be enrolled into 1 of 2 treatment arms according to their disease status. A disease assessment will be performed every 8 or 9 weeks (± 3 days) depending on the treatment arm assignment. The assessment will be based both on changes in clinical symptoms, and radiographic images. Subjects without evidence of disease progression may continue to receive treatment based on their original treatment assignment until disease progression or intolerability. A safety follow-up visit will occur 4 weeks after the last dose infusion of AGS-8M4.
- Conditions
- Carcinoma, Ovarian Cancer, Ovarian Diseases, Ovarian Neoplasms
- Being tested
- AGS-8M4, Pegylated liposomal doxorubicin (PLD), gemcitabine, carboplatin
- Keywords
- Clinical Trial, Phase1, Combination Drug Therapy, pharmacokinetics, safety, Ovarian
- Medical subject headings
- Carcinoma, Ovarian Neoplasms, Ovarian Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGS-8M4Biological
IV infusion
Pegylated liposomal doxorubicin (PLD)Drug
IV infusion
gemcitabineDrug
IV infusion
carboplatinDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| A. PLD plus AGS-8M4 | Experimental | Women with platinum resistent ovarian cancer Receives: Biological: AGS-8M4; Drug: Pegylated liposomal doxorubicin (PLD) |
| B. Carboplatin and gemcitabine plus AGS-8M4 | Experimental | Women with platinum sensitive ovarian cancer Receives: Biological: AGS-8M4; Drug: gemcitabine; Drug: carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: Throughout the treatment
Secondary outcomes (4)
Assessment of PK variables
Measured: Treatment Arm A: Weeks 1 and 3 of each cycle. Treatment Arm B: Week 1 of each cycle. In addition, samples will be drawn at the Safety F/U, 2 Month F/U and 3 Month F/U visits.
Incidence of anti-AGS-8M4 antibody formation
Measured: Treatment Arm A: Day 1 of every other cycle and at Day 15 for the first cycle only. Treatment Arm B: Day 1 of every other cycle. In addition, samples will be drawn at the Safety F/U, 2 Month F/U and 3 Month F/U visits.
Changes in tumor status per RECIST
Measured: Treatment Arm A: Every 8 weeks. Treatment Arm B: Every 9 weeks.
Change in CA-125 levels
Measured: Treatment Arm A: Day 1 and Day 15 of each cycle. Treatment Arm B: Day 1 of each cycle. In addition, samples will be drawn at the Safety F/U.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: Trial was terminated to allow sponsors to evaluate the future development of the drug program
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Agensys, Inc.
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study director, Agensys, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016054
- Sponsor's protocol ID
- 2009001
- Status last verified
- Feb 2013
- First submitted
- 16 Nov 2009
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Parallel Arm, Multicenter, Open-Label Study of the Safety and Pharmacokinetics of AGS-8M4 Given in Combination With Two Different Chemotherapy Regimens in Women With Platinum Resistant or Platinum Sensitive Ovarian Cancer
- ClinicalTrials.gov ID
- NCT01016054
- Acronym / sponsor ID
- 2009001
- Conditions
- Carcinoma, Ovarian Cancer, Ovarian Diseases, Ovarian Neoplasms
- Keywords
- Clinical Trial, Phase1, Combination Drug Therapy, pharmacokinetics, safety, Ovarian
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial was terminated to allow sponsors to evaluate the future development of the drug program
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Agensys, Inc.
- Study start
- Oct 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 18 Nov 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.
This is a parallel arm study to evaluate AGS-8M4 administered in combination with chemotherapy in subjects with ovarian cancer. AGS-8M4 will be administered as an IV infusion until disease worsens.
Detailed description
All Subjects will receive AGS-8M4 treatment. Subjects will be enrolled into 1 of 2 treatment arms according to their disease status. A disease assessment will be performed every 8 or 9 weeks (± 3 days) depending on the treatment arm assignment. The assessment will be based both on changes in clinical symptoms, and radiographic images. Subjects without evidence of disease progression may continue to receive treatment based on their original treatment assignment until disease progression or intolerability. A safety follow-up visit will occur 4 weeks after the last dose infusion of AGS-8M4.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A. PLD plus AGS-8M4 | Experimental | Biological: AGS-8M4, Drug: Pegylated liposomal doxorubicin (PLD)Women with platinum resistent ovarian cancer |
| B. Carboplatin and gemcitabine plus AGS-8M4 | Experimental | Biological: AGS-8M4, Drug: gemcitabine, Drug: carboplatinWomen with platinum sensitive ovarian cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with recurrent disease Stage III/IV diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma
- Subjects with either platinum resistant or platinum sensitive ovarian cancer
- At least 14 days of previous cytotoxic chemotherapy and have recovered from all toxicities
- Left ventricular ejection fraction (LVEF) equal to or greater than the institutional lower limit of normal as measured by echocardiogram or MUGA (ONLY required for platinum resistant patients)
Key exclusion criteria (5 listed)
- Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of screening
- Use of any investigational drug within 30 days prior to screening
- Prior monoclonal antibody therapy other than Avastin
- Avastin administration within 90 days of screening
- History of thromboembolic events and bleeding disorders ≤ 3 months (e.g.,DVT or PE)
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 |
|---|---|---|
| AGS-8M4IV infusion | Biological | A. PLD plus AGS-8M4, B. Carboplatin and gemcitabine plus AGS-8M4 |
| Pegylated liposomal doxorubicin (PLD)IV infusion | Drug | A. PLD plus AGS-8M4 |
| gemcitabineIV infusion | Drug | B. Carboplatin and gemcitabine plus AGS-8M4 |
| carboplatinIV infusion | Drug | B. Carboplatin and gemcitabine plus AGS-8M4 |
Primary outcome
Incidence of adverse events
Time frame: Throughout the treatment
4 secondary outcomes
Assessment of PK variables
Time frame: Treatment Arm A: Weeks 1 and 3 of each cycle. Treatment Arm B: Week 1 of each cycle. In addition, samples will be drawn at the Safety F/U, 2 Month F/U and 3 Month F/U visits.
Incidence of anti-AGS-8M4 antibody formation
Time frame: Treatment Arm A: Day 1 of every other cycle and at Day 15 for the first cycle only. Treatment Arm B: Day 1 of every other cycle. In addition, samples will be drawn at the Safety F/U, 2 Month F/U and 3 Month F/U visits.
Changes in tumor status per RECIST
Time frame: Treatment Arm A: Every 8 weeks. Treatment Arm B: Every 9 weeks.
Change in CA-125 levels
Time frame: Treatment Arm A: Day 1 and Day 15 of each cycle. Treatment Arm B: Day 1 of each cycle. In addition, samples will be drawn at the Safety F/U.
Results and safety
The study was stopped early (reason given: Trial was terminated to allow sponsors to evaluate the future development of the drug program). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2013.
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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.
Use Central Contact study director
Agensys, 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 AGS-8M4, Pegylated liposomal doxorubicin (PLD) and gemcitabine in people with Carcinoma and Ovarian Cancer, run by Astellas Pharma Inc at 1 site 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 5 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: stopped early, as of the sponsor's last update on 27 Feb 2013. 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 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 was stopped early (reason given: Trial was terminated to allow sponsors to evaluate the future development of the drug program). Results are not available in the source record.
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?
Incidence of adverse events (time frame: Throughout the treatment). 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 27 Feb 2013.