CancerPhase 1NCT00770536
AMG386 Comb w. Either Pegylated Liposomal Doxorubicin or Topotecan Subjects w. Advanced Recurrent Epithelial Ovarian CR
A Phase 1 study testing A1: AMG 386 10 mg/kg + Liposomal doxorubicin, A3: AMG 386 15mg/kg + Liposomal doxorubicin and B1: AMG 386 10 mg/kg + Topotecan in people with Cancer and Carcinoma, run by Amgen at 16 sites in 3 countries.
Trial summary
This study is a 2 part, 2 cohort, open-label, dose escalation/de escalation study of AMG 386 in combination with either pegylated liposomal doxorubicin or topotecan in subjects with recurrent ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer, Carcinoma, Fallopian Tube Cancer
- What is being tested?
- A1: AMG 386 10 mg/kg + Liposomal doxorubicin, A3: AMG 386 15mg/kg + Liposomal doxorubicin and B1: AMG 386 10 mg/kg + Topotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 16 sitesin 3 countries
- Study dates
- Jan 2009to Jun 2015
- 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
- Histologically or cytologically documented recurrent invasive epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Subjects must have received at least one platinum containing regimen
- Radiographically documented progression per RECIST criteria with modifications or progression of CA 125 as adopted by GCIG during or subsequent to the last chemotherapy regimen
- Subjects may include those with measurable or non measurable disease
- All scans and x-rays used to document measurable or non measurable disease must be done within 28 days prior to enrollment
- Female 18 years of age or older at the time the written informed consent is obtained
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- GOG Performance Status of 0 or 1
- Left Ventricular Ejection Fraction (LVEF) >= institutional lower limit of normal for subjects assigned to cohort A only
- Adequate organ function as assessed by laboratory studies (hematological and chemistries)
- Life expectancy >= 3 months (per investigator opinion)
- Subjects of child bearing potential who have not undergone a bilateral salpingo oophorectomy and are sexually active must consent to use an accepted and effective double barrier non hormonal method of contraception from signing the informed consent through 6 months after last dose of study drug
Who cannot join
- Subjects believed to be a higher than average risk of bowel perforation. This includes symptoms of partial or complete bowel obstruction, recent (within 6 months) history of fistula or bowel perforation, subjects requiring total parenteral nutrition and continuous hydration
- Previous abdominal /or pelvic external beam radiotherapy
- Known history of central nervous system metastases
- Subjects with a history of prior malignancy, except:
- Malignancy treated with curative intent and with no known active disease present for >= 3 years before study day 1 and felt to be at low risk for recurrence by treating physician
- Adequately treated non melanomatous skin cancer or lentigo maligna without evidence of disease
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- Adequately treated cervical carcinoma in situ without evidence of disease
- Prior myeloablative high dose chemotherapy with allogeneic or autologous stem cell (or bone marrow) transplant
- History of arterial or deep venous thromboembolism within 12 months prior to enrollment
- Clinically significant cardiac disease within 12 months prior to enrollment
- Prior treatment with doxorubicin or pegylated liposomal doxorubicin (cohort A subjects) and topotecan (cohort B subjects)
- Current or within 30 days prior to enrollment treatment with immune modulators such as systemic cyclosporine and tacrolimus
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
United States9 sites
Research Site
Bismarck, North Dakota, 58501
Research Site
Columbus, Ohio, 43219
Research Site
Orlando, Florida, 32806
Research Site
Philadelphia, Pennsylvania, 19111
Research Site
Sacramento, California, 95817
Research Site
Saint Louis Park, Minnesota, 55426
Research Site
Tampa, Florida, 33612
Research Site
Tucson, Arizona, 85724-5024
Research Site
Winston-Salem, North Carolina, 27103
Belgium4 sites
Research Site
Leuven, 3000
Research Site
Liège, 4000
Research Site
Liège, 4000
Research Site
Wilrijk, 2610
Australia3 sites
Research Site
Adelaide, South Australia, 5000
Research Site
Footscray, Victoria, 3011
Research Site
Parkville, Victoria, 3050
About this study
Official title: A Phase 1b Study of AMG 386 in Combination With Either Pegylated Liposomal Doxorubicin or Topotecan in Subjects With Advanced Recurrent Epithelial Ovarian Cancer
This study is a 2 part, 2 cohort, open-label, dose escalation/de escalation study of AMG 386 in combination with either pegylated liposomal doxorubicin or topotecan in subjects with recurrent ovarian cancer. Up to 100 subjects will be enrolled to receive AMG 386 in combination with either pegylated liposomal doxorubicin every 4 weeks (cohort A) or topotecan weekly on days 1, 8, and 15 of a 28 day dosing schedule (cohort B). Subject enrollment and assignment to either cohort will be based on eligibility and the investigator's discretion.
It is hypothesized that AMG 386, in combination with each of the chemotherapy regimens: either pegylated liposomal doxorubicin or topotecan will be safe and well tolerated in subjects with recurrent ovarian cancer.
Read the detailed description
The purpose of this study is to evaluate the effectiveness and safety of AMG 386 when used with pegylated liposomal doxorubicin or topotecan in subjects with advanced recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Conditions
- Cancer, Carcinoma, Fallopian Tube Cancer, Gynecological Malignancies, Metastases, Oncology
- Being tested
- A1: AMG 386 10 mg/kg + Liposomal doxorubicin, A3: AMG 386 15mg/kg + Liposomal doxorubicin, B1: AMG 386 10 mg/kg + Topotecan, B3: AMG 386 15mg/kg + Topotecan
- Keywords
- fallopian tube cancer, Gynecological Malignancy, primary peritoneal cancer of predominantly epithelial origin, Stage II to IV ovarian cancer
- Medical subject headings
- Neoplasms, Carcinoma, Fallopian Tube Neoplasms, Neoplasm Metastasis, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A1: AMG 386 10 mg/kg + Liposomal doxorubicinDrug
Also called Liposomal doxorubicin, AMG 386
Liposomal doxorubicin 50 mg/m2 IV Q4W in combination with AMG 386 10 mg/kg IV QW
A3: AMG 386 15mg/kg + Liposomal doxorubicinDrug
Also called AMG 386, Liposomal doxorubicin
A3: AMG 386 15 mg/kg IV QW + Liposomal doxorubicin 50 mg/m2 IV Q4W
B1: AMG 386 10 mg/kg + TopotecanDrug
Also called Topotecan, AMG 386
B1: AMG 386 10 mg/kg IV QW + Topotecan 4 mg/m2 IV days 1, 8, 15, of a 28 day dosing schedule
B3: AMG 386 15mg/kg + TopotecanDrug
Also called AMG 386, Topotecan
AMG 386 15mg/kg IV QW + Topotecan 4mg/m2 IV days 1, 8, 15 of a 28 day dosing schedule
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | In part 1, six subjects will be assigned to each cohort A or B. This is a dose escalation/de escalation study with a 6 + 3 design based on the incidence of DLTs (dose limiting toxicities) during the first 4 weeks of combined therapy [(cohort A: AMG 386 and pegylated liposomal doxorubicin) or (cohort B: AMG 386 and topotecan)]. Receives: Drug: A1: AMG 386 10 mg/kg + Liposomal doxorubicin; Drug: A3: AMG 386 15mg/kg + Liposomal doxorubicin; Drug: B1: AMG 386 10 mg/kg + Topotecan; Drug: B3: AMG 386 15mg/kg + Topotecan |
| Part 2 | Experimental | The decision on declaration of a safe and tolerable dose during part 1 will lead to part 2 (cohort A: liposomal doxorubicin + AMG 386 MTD (max tolerated dose) of part 1, cohort B: Topotecan + AMG 386 MTD (max tolerated dose) of part 1 Receives: Drug: A1: AMG 386 10 mg/kg + Liposomal doxorubicin; Drug: A3: AMG 386 15mg/kg + Liposomal doxorubicin; Drug: B1: AMG 386 10 mg/kg + Topotecan; Drug: B3: AMG 386 15mg/kg + Topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to identify the incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicity in subjects treated with AMG 386 + pegylated liposomal doxorubicin (cohort A) and with AMG 386 + topotecan
Measured: first 4 weeks of treatment
Secondary outcomes (4)
To evaluate the treatment effect as measured by: objective response rate (ORR), duration of response (DOR), PFS, change in tumor burden, CA 125 Response and Progression by GCIG and CA-125 duration of response
Measured: Treatment and follow-up phase of study
To evaluate the incidence of adverse events and clinical laboratory abnormalities not defined as DLTs.
Measured: first 4 weeks of treatment
To determine the pharmacokinetics of pegylated liposomal doxorubicin (and its metabolite, doxorubicinol), topotecan and AMG 386 (Cmax, AUC, and Cmin for intensive assessment; Cmax and Cmin for sparse assessment).
Measured: Treatment and follow-up phase of study
To estimate the incidence of anti AMG 386 antibody formation.
Measured: Treatment and follow-up phase of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2008 (estimated)
- Study startJan 2009
- Primary completionJan 2012
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 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
- NCT00770536
- Sponsor's protocol ID
- 20070182
- Status last verified
- Sep 2015
- First submitted
- 9 Oct 2008
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of AMG 386 in Combination With Either Pegylated Liposomal Doxorubicin or Topotecan in Subjects With Advanced Recurrent Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00770536
- Acronym / sponsor ID
- 20070182
- Conditions
- Cancer, Carcinoma, Fallopian Tube Cancer, Gynecological Malignancies, Metastases, Oncology
- Keywords
- fallopian tube cancer, Gynecological Malignancy, primary peritoneal cancer of predominantly epithelial origin, Stage II to IV ovarian cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Oct 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 study is a 2 part, 2 cohort, open-label, dose escalation/de escalation study of AMG 386 in combination with either pegylated liposomal doxorubicin or topotecan in subjects with recurrent ovarian cancer. Up to 100 subjects will be enrolled to receive AMG 386 in combination with either pegylated liposomal doxorubicin every 4 weeks (cohort A) or topotecan weekly on days 1, 8, and 15 of a 28 day dosing schedule (cohort B). Subject enrollment and assignment to either cohort will be based on eligibility and the investigator's discretion.
It is hypothesized that AMG 386, in combination with each of the chemotherapy regimens: either pegylated liposomal doxorubicin or topotecan will be safe and well tolerated in subjects with recurrent ovarian cancer.
Detailed description
The purpose of this study is to evaluate the effectiveness and safety of AMG 386 when used with pegylated liposomal doxorubicin or topotecan in subjects with advanced recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: A1: AMG 386 10 mg/kg + Liposomal doxorubicin, Drug: A3: AMG 386 15mg/kg + Liposomal doxorubicin, Drug: B1: AMG 386 10 mg/kg + Topotecan, Drug: B3: AMG 386 15mg/kg + TopotecanIn part 1, six subjects will be assigned to each cohort A or B. This is a dose escalation/de escalation study with a 6 + 3 design based on the incidence of DLTs (dose limiting toxicities) during the first 4 weeks of combined therapy [(cohort A: AMG 386 and pegylated liposomal doxorubicin) or (cohort B: AMG 386 and topotecan)]. |
| Part 2 | Experimental | Drug: A1: AMG 386 10 mg/kg + Liposomal doxorubicin, Drug: A3: AMG 386 15mg/kg + Liposomal doxorubicin, Drug: B1: AMG 386 10 mg/kg + Topotecan, Drug: B3: AMG 386 15mg/kg + TopotecanThe decision on declaration of a safe and tolerable dose during part 1 will lead to part 2 (cohort A: liposomal doxorubicin + AMG 386 MTD (max tolerated dose) of part 1, cohort B: Topotecan + AMG 386 MTD (max tolerated dose) of part 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically or cytologically documented recurrent invasive epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Subjects must have received at least one platinum containing regimen
- Radiographically documented progression per RECIST criteria with modifications or progression of CA 125 as adopted by GCIG during or subsequent to the last chemotherapy regimen
- Subjects may include those with measurable or non measurable disease
- All scans and x-rays used to document measurable or non measurable disease must be done within 28 days prior to enrollment
Key exclusion criteria (12 listed)
- Subjects believed to be a higher than average risk of bowel perforation. This includes symptoms of partial or complete bowel obstruction, recent (within 6 months) history of fistula or bowel perforation, subjects requiring total parenteral nutrition and continuous hydration
- Previous abdominal /or pelvic external beam radiotherapy
- Known history of central nervous system metastases
- Subjects with a history of prior malignancy, except:
- Prior myeloablative high dose chemotherapy with allogeneic or autologous stem cell (or bone marrow) transplant
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 |
|---|---|---|
| A1: AMG 386 10 mg/kg + Liposomal doxorubicinAlso: Liposomal doxorubicin, AMG 386Liposomal doxorubicin 50 mg/m2 IV Q4W in combination with AMG 386 10 mg/kg IV QW | Drug | Part 1, Part 2 |
| A3: AMG 386 15mg/kg + Liposomal doxorubicinAlso: AMG 386, Liposomal doxorubicinA3: AMG 386 15 mg/kg IV QW + Liposomal doxorubicin 50 mg/m2 IV Q4W | Drug | Part 1, Part 2 |
| B1: AMG 386 10 mg/kg + TopotecanAlso: Topotecan, AMG 386B1: AMG 386 10 mg/kg IV QW + Topotecan 4 mg/m2 IV days 1, 8, 15, of a 28 day dosing schedule | Drug | Part 1, Part 2 |
| B3: AMG 386 15mg/kg + TopotecanAlso: AMG 386, TopotecanAMG 386 15mg/kg IV QW + Topotecan 4mg/m2 IV days 1, 8, 15 of a 28 day dosing schedule | Drug | Part 1, Part 2 |
Primary outcome
The primary objective is to identify the incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicity in subjects treated with AMG 386 + pegylated liposomal doxorubicin (cohort A) and with AMG 386 + topotecan
Time frame: first 4 weeks of treatment
4 secondary outcomes
To evaluate the treatment effect as measured by: objective response rate (ORR), duration of response (DOR), PFS, change in tumor burden, CA 125 Response and Progression by GCIG and CA-125 duration of response
Time frame: Treatment and follow-up phase of study
To evaluate the incidence of adverse events and clinical laboratory abnormalities not defined as DLTs.
Time frame: first 4 weeks of treatment
To determine the pharmacokinetics of pegylated liposomal doxorubicin (and its metabolite, doxorubicinol), topotecan and AMG 386 (Cmax, AUC, and Cmin for intensive assessment; Cmax and Cmin for sparse assessment).
Time frame: Treatment and follow-up phase of study
To estimate the incidence of anti AMG 386 antibody formation.
Time frame: Treatment and follow-up phase 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 Sep 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
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing A1: AMG 386 10 mg/kg + Liposomal doxorubicin, A3: AMG 386 15mg/kg + Liposomal doxorubicin and B1: AMG 386 10 mg/kg + Topotecan in people with Cancer and Carcinoma, run by Amgen at 16 sites in 3 countries.
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 11 inclusion and 12 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 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Belgium, Australia. 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?
The primary objective is to identify the incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicity in subjects treated with AMG 386 + pegylated liposomal doxorubicin (cohort A) and with AMG 386 + topotecan (time frame: first 4 weeks of 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 29 Sep 2015.