Ovarian Cancer, Primary Peritoneal CancerPhase 1/2NCT00635193
Efficacy and Safety Study of M200(Volociximab in Combination With Liposomal Doxorubicin)
A Phase 1/2 study testing M200 (Volociximab) and Liposomal Doxorubicin in people with Ovarian Cancer, Primary Peritoneal Cancer, run by AbbVie (prior sponsor, Abbott) at 39 sites in 9 countries.
Trial summary
This is an open-label study of liposomal doxorubicin with or without volociximab for the treatment of subjects with advanced epithelial ovarian cancer or primary peritoneal cancer relapsed after prior therapy with Plat/Taxane-based chemo. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Primary Peritoneal Cancer
- What is being tested?
- M200 (Volociximab) and Liposomal Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 39 sitesin 9 countries
- Study dates
- Jul 2007to Oct 2009
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females aged >= 18 years old at the time of informed consent.
- Advanced (Stage III or IV) histologically documented epithelial ovarian cancer or primary peritoneal cancer (excluding small, round-cell histologies).
- Recurrent or persistent disease.
- Received no more than 2 prior cancer treatment regimens, at least one of which must have included a platinum/taxane based therapy. If the same regimen is given more than once, it will count as one regimen. If components of a regimen are given more than once using the same schedule, it will count as one regimen.
- At least 1 target lesion to assess response by RECIST criteria. (Tumors within a previously irradiated field are designated as non-target)
- Other protocol-defined inclusion criteria apply.
Who cannot join
- Subjects taking immunomodulatory agents including, but not limited to, interferons, interleukins, systemic steroids, cyclosporine, tacrolimus, calcineurin inhibitors, chronic low dose methotrexate, or azathioprine. (Use of inhaled or intranasal steroids or oral steroids 10 mg/day prednisone or its equivalent are permitted.)
- Subjects who require treatment with an anti coagulant with the exception of low dose Aspirin® (81 mg/day), warfarin (1 mg/day), or heparin for IV catheter patency
- Evidence of bleeding diathesis or coagulopathy. (Prior history of DVT will not exclude subjects from participating in this study.)
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1.
- Non-healing wound, ulcer, or bone fracture.
- Evidence of autoimmune disease including, but not limited to, ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, and other disease in which immune function or immune competence is known to be impaired.
- Active infection requiring systemic antibiotics, antivirals, or antifungals including HIV/AIDS, hepatitis B, or hepatitis C infection.
- Other protocol-defined exclusion criteria apply
Trial locations and contacts
39 sites in 9 countries.
39 sites in 9 countries
United States14 sites
Site Reference ID/Investigator# 75281
Anaheim, California, 92801
Site Reference ID/Investigator# 75299
Atlanta, Georgia, 30309
Site Reference ID/Investigator# 75274
Baltimore, Maryland, 21215
Site Reference ID/Investigator# 75295
Corpus Christi, Texas, 78404
Site Reference ID/Investigator# 75280
Dallas, Texas, 75246
Site Reference ID/Investigator# 75297
Danville, Virginia, 23185
Site Reference ID/Investigator# 75278
Green Bay, Wisconsin, 54301
Site Reference ID/Investigator# 75301
Hinsdale, Illinois, 60521
Site Reference ID/Investigator# 75294
Jackson, Missouri, 65109
Site Reference ID/Investigator# 75279
Oklahoma City, Oklahoma, 73104
Site Reference ID/Investigator# 75275
Redondo Beach, California, 90277
Site Reference ID/Investigator# 75300
Savannah, Georgia, 31404
Site Reference ID/Investigator# 75296
Sunrise, Florida, 33323
Site Reference ID/Investigator# 75298
Williamsburg, Virginia, 23185
Poland7 sites
Site Reference ID/Investigator# 75344
Bialystok, 15-027
Site Reference ID/Investigator# 75339
Krakow, 31-531
Site Reference ID/Investigator# 75341
Lublin, 20-090
Site Reference ID/Investigator# 75342
Poznan, 61-001
Site Reference ID/Investigator# 75343
Poznan, 61-848
Site Reference ID/Investigator# 75345
Szczecin, 70-111
Site Reference ID/Investigator# 75340
Wroclaw, 50-367
Spain5 sites
Site Reference ID/Investigator# 75349
Barcelona, 08035
Site Reference ID/Investigator# 75351
Barcelona, 08036
Site Reference ID/Investigator# 75352
Barcelona, 08208
Site Reference ID/Investigator# 75350
Girona, 17007
Site Reference ID/Investigator# 75353
Madrid, 28040
Belgium3 sites
Site Reference ID/Investigator# 75337
Antwerp, 2020
Site Reference ID/Investigator# 75336
Brussels, 1200
Site Reference ID/Investigator# 75338
Leuven, 3000
Russia3 sites
Site Reference ID/Investigator# 75346
Moscow, 129128
Site Reference ID/Investigator# 75348
Moscow, 143423
Site Reference ID/Investigator# 75347
Saint Petersburg, 198255
Australia2 sites
Site Reference ID/Investigator# 75334
Toorak Gardens, 5065
Site Reference ID/Investigator# 75335
Woodville South, 5011
Italy2 sites
Site Reference ID/Investigator# 75415
Milan, 20133
Site Reference ID/Investigator# 75333
Milan, 20141
Sweden2 sites
Site Reference ID/Investigator# 75354
Stockholm, 17176
Site Reference ID/Investigator# 75355
Umeå, 901 85
About this study
Official title: A Phase 1/2, Open-Label, Adaptive, Randomized Study of Liposomal Doxorubicin With or Without M200 (Volociximab) for the Treatment of Subjects With Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer That Have Relapsed After Prior Therapy With a Platinum/Taxane-Based Chemotherapy
This is an open-label study of liposomal doxorubicin with or without volociximab for the treatment of subjects with advanced epithelial ovarian cancer or primary peritoneal cancer relapsed after prior therapy with Plat/Taxane-based chemo. Volociximab is an anti-angiogenic integrin inhibitor being developed for the treatment of solid tumors. Preclinical data with a surrogate volociximab antibody administered as monotherapy indicate encouraging efficacy in terms of tumor reduction and anti-angiogenic effects in mouse ovarian cancer xenograft models. In clinical studies, volociximab has been evaluated in several solid tumor types, including pancreatic, renal, and melanoma, with many subjects who entered the studies with progressive disease remaining progression-free for several months. In all studies in solid tumors, volociximab has shown a favorable safety profile when administered at 10 mg/kg q2wks and more recently at 15 mg/kg qwk. A study of volociximab in combination with liposomal doxorubicin in subjects with ovarian cancer or primary peritoneal cancer who have relapsed after prior platin/taxane therapies is warranted to further evaluate the drug's efficacy and safety. The investigators have thus far activated stage 2 of this study at 11/25 sites. Worldwide, the study aims to enroll 150 subjects.
Read the detailed description
This is an open-label study of liposomal doxorubicin with or without volociximab for the treatment of subjects with advanced epithelial ovarian cancer or primary peritoneal cancer relapsed after prior therapy with Plat/Taxane-based chemo. Volociximab is an anti-angiogenic integrin inhibitor being developed for the treatment of solid tumors. Preclinical data with a surrogate volociximab antibody administered as monotherapy indicate encouraging efficacy in terms of tumor reduction and anti-angiogenic effects in mouse ovarian cancer xenograft models. In clinical studies, volociximab has been evaluated in several solid tumor types, including pancreatic, renal, and melanoma, with many subjects who entered the studies with progressive disease remaining progression-free for several months.
- Being tested
- M200 (Volociximab), Liposomal Doxorubicin
- Keywords
- Ovarian neoplasms, Angiogenesis inhibitors, Angiogenesis, Volociximab, Ovarian cancer, Antibody, Monoclonals
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M200 (Volociximab)Drug
7.5 mg/kg, IV infusion every week until disease progression
Liposomal DoxorubicinDrug
40 mg/m2, IV infustions every 4 weeks until disease progression, the maxium number of doses a subject can receive is 12.
M200 (Volociximab)Drug
15 mg/kg, IV infusions every week until disease progression
M200 (Volociximab)Drug
15 mg/kg, IV infustions every other week until disease progression
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | Three subjects will be treated with liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab, 7.5 mg/kg qwk Receives: Drug: M200 (Volociximab); Drug: Liposomal Doxorubicin |
| Cohort 2 | Other | liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg qwk Receives: Drug: Liposomal Doxorubicin; Drug: M200 (Volociximab) |
| Group A | Other | liposomal doxorubicin, 40 mg/m2 q4wk Receives: Drug: Liposomal Doxorubicin |
| Group B | Other | liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg q2wk (or other dose and schedule) Receives: Drug: Liposomal Doxorubicin; Drug: M200 (Volociximab) |
| Group C | Other | liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg qwk (or other dose and schedule) Receives: Drug: Liposomal Doxorubicin; Drug: M200 (Volociximab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of volociximab in combination with liposomal doxorubicin in advanced epithelial ovarian cancer or primary peritoneal cancer. To evaluate the safety and tolerability of volociximab in combination with liposomal doxorubicin.
Measured: 50-57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startJul 2007
- Primary completionOct 2008
- Study completionOct 2009
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 Ovarian Cancer, Primary Peritoneal CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biogen
- Responsible party
- Sponsor
- Investigators
- Mihail Obrocea, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635193
- Sponsor's protocol ID
- 206OC202
- Other IDs
- 2007-000509-31
- Status last verified
- Jan 2013
- First submitted
- 5 Mar 2008
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.
PubMed 37407274
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-Label, Adaptive, Randomized Study of Liposomal Doxorubicin With or Without M200 (Volociximab) for the Treatment of Subjects With Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer That Have Relapsed After Prior Therapy With a Platinum/Taxane-Based Chemotherapy
- ClinicalTrials.gov ID
- NCT00635193
- Acronym / sponsor ID
- 206OC202
- Keywords
- Ovarian neoplasms, Angiogenesis inhibitors, Angiogenesis, Volociximab, Ovarian cancer, Antibody, Monoclonals
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Collaborators
- Biogen
- Study start
- Jul 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 13 Mar 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 is an open-label study of liposomal doxorubicin with or without volociximab for the treatment of subjects with advanced epithelial ovarian cancer or primary peritoneal cancer relapsed after prior therapy with Plat/Taxane-based chemo. Volociximab is an anti-angiogenic integrin inhibitor being developed for the treatment of solid tumors. Preclinical data with a surrogate volociximab antibody administered as monotherapy indicate encouraging efficacy in terms of tumor reduction and anti-angiogenic effects in mouse ovarian cancer xenograft models. In clinical studies, volociximab has been evaluated in several solid tumor types, including pancreatic, renal, and melanoma, with many subjects who entered the studies with progressive disease remaining progression-free for several months. In all studies in solid tumors, volociximab has shown a favorable safety profile when administered at 10 mg/kg q2wks and more recently at 15 mg/kg qwk. A study of volociximab in combination with liposomal doxorubicin in subjects with ovarian cancer or primary peritoneal cancer who have relapsed after prior platin/taxane therapies is warranted to further evaluate the drug's efficacy and safety. The investigators have thus far activated stage 2 of this study at 11/25 sites. Worldwide, the study aims to enroll 150 subjects.
Detailed description
This is an open-label study of liposomal doxorubicin with or without volociximab for the treatment of subjects with advanced epithelial ovarian cancer or primary peritoneal cancer relapsed after prior therapy with Plat/Taxane-based chemo. Volociximab is an anti-angiogenic integrin inhibitor being developed for the treatment of solid tumors. Preclinical data with a surrogate volociximab antibody administered as monotherapy indicate encouraging efficacy in terms of tumor reduction and anti-angiogenic effects in mouse ovarian cancer xenograft models. In clinical studies, volociximab has been evaluated in several solid tumor types, including pancreatic, renal, and melanoma, with many subjects who entered the studies with progressive disease remaining progression-free for several months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Other | Drug: M200 (Volociximab), Drug: Liposomal DoxorubicinThree subjects will be treated with liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab, 7.5 mg/kg qwk |
| Cohort 2 | Other | Drug: Liposomal Doxorubicin, Drug: M200 (Volociximab)liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg qwk |
| Group A | Other | Drug: Liposomal Doxorubicinliposomal doxorubicin, 40 mg/m2 q4wk |
| Group B | Other | Drug: Liposomal Doxorubicin, Drug: M200 (Volociximab)liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg q2wk (or other dose and schedule) |
| Group C | Other | Drug: Liposomal Doxorubicin, Drug: M200 (Volociximab)liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg qwk (or other dose and schedule) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Females aged >= 18 years old at the time of informed consent.
- Advanced (Stage III or IV) histologically documented epithelial ovarian cancer or primary peritoneal cancer (excluding small, round-cell histologies).
- Recurrent or persistent disease.
- Received no more than 2 prior cancer treatment regimens, at least one of which must have included a platinum/taxane based therapy. If the same regimen is given more than once, it will count as one regimen. If components of a regimen are given more than once using the same schedule, it will count as one regimen.
- At least 1 target lesion to assess response by RECIST criteria. (Tumors within a previously irradiated field are designated as non-target)
Key exclusion criteria (8 listed)
- Subjects taking immunomodulatory agents including, but not limited to, interferons, interleukins, systemic steroids, cyclosporine, tacrolimus, calcineurin inhibitors, chronic low dose methotrexate, or azathioprine. (Use of inhaled or intranasal steroids or oral steroids 10 mg/day prednisone or its equivalent are permitted.)
- Subjects who require treatment with an anti coagulant with the exception of low dose Aspirin® (81 mg/day), warfarin (1 mg/day), or heparin for IV catheter patency
- Evidence of bleeding diathesis or coagulopathy. (Prior history of DVT will not exclude subjects from participating in this study.)
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1.
- Non-healing wound, ulcer, or bone fracture.
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 |
|---|---|---|
| M200 (Volociximab)7.5 mg/kg, IV infusion every week until disease progression | Drug | Cohort 1 |
| Liposomal Doxorubicin40 mg/m2, IV infustions every 4 weeks until disease progression, the maxium number of doses a subject can receive is 12. | Drug | Cohort 1, Cohort 2, Group A, Group B, Group C |
| M200 (Volociximab)15 mg/kg, IV infusions every week until disease progression | Drug | Cohort 2, Group C |
| M200 (Volociximab)15 mg/kg, IV infustions every other week until disease progression | Drug | Group B |
Primary outcome
To evaluate the efficacy of volociximab in combination with liposomal doxorubicin in advanced epithelial ovarian cancer or primary peritoneal cancer. To evaluate the safety and tolerability of volociximab in combination with liposomal doxorubicin.
Time frame: 50-57 days
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 18 Jan 2013.
- Derived from this study: PubMed 37407274Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.
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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.
Mihail Obrocea, MD study director
AbbVie
39 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing M200 (Volociximab) and Liposomal Doxorubicin in people with Ovarian Cancer, Primary Peritoneal Cancer, run by AbbVie (prior sponsor, Abbott) at 39 sites in 9 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 6 inclusion and 8 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 18 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Poland, Spain, Belgium, Russia and 4 more countries. 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 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?
To evaluate the efficacy of volociximab in combination with liposomal doxorubicin in advanced epithelial ovarian cancer or primary peritoneal cancer. To evaluate the safety and tolerability of volociximab in combination with liposomal doxorubicin. (time frame: 50-57 days). 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 NCT00635193, 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 18 Jan 2013.