Epithelial Ovarian CancerPhase 2NCT01447706
A Study of MM-121 With Paclitaxel in Platinum Resistant/ Refractory Advanced Ovarian Cancers
A Phase 2 study testing MM-121 and Paclitaxel in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Merrimack Pharmaceuticals at 10 sites in United States.
Trial summary
To determine whether the combination of MM-121 plus paclitaxel is more effective than paclitaxel alone Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- What is being tested?
- MM-121 and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2011to Jun 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Locally advanced/metastatic or recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
- Received at least one prior platinum based chemotherapy regimen
- Platinum-resistant or refractory
- Eligible for weekly paclitaxel
- Adequate liver and kidney function
- 18 years of age or above
Who cannot join
- Evidence of any other active malignancy
- History of severe allergic reactions to paclitaxel or other drugs formulated in Cremophor®EL
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
Carolinas Medical Center/Blumenthal Cancer Center
Charlotte, North Carolina, 28203
Chattanooga GYN Oncology
Chattanooga, Tennessee, 37403
Wilshire Oncology Medical Group
Corona, California, 92879
Arizona Center for Cancer Care
Glendale, Arizona, 85306
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202
North County Oncology
Oceanside, California, 92056
Central Coast Medical Oncology
Santa Maria, California, 93454
Pinnacle Oncology
Scottsdale, Arizona, 85258
ProMedica Health System, Inc.
Toledo, Ohio, 43606
About this study
Official title: A Phase II Randomized Open Label Study of MM-121 in Combination With Paclitaxel Versus Paclitaxel Alone in Patients With Platinum Resistant/ Refractory Advanced Ovarian Cancers
To determine whether the combination of MM-121 plus paclitaxel is more effective than paclitaxel alone
Read the detailed description
This is a multicenter, open-label, randomized, Phase II study of MM-121 in patients with platinum resistant or refractory recurrent/advanced ovarian cancers. Up to 210 patients will be randomized (2:1) to receive MM-121 plus paclitaxel or paclitaxel alone.
- Being tested
- MM-121, Paclitaxel
- Keywords
- Ovarian Cancer, Platinum-resistant, Platinum-refractory, Fallopian tube cancer, Peritoneal Cancer, Paclitaxel, ErbB3, Phase II, locally advanced/metastatic or recurrent
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Ovarian Neoplasms, Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MM-121Drug
Also called SAR256212
MM-121 (SAR256212) (IV)
PaclitaxelDrug
Standard dosing Paclitaxel (IV)
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel | Active comparator | Standard dosing paclitaxel: 80 mg/m2 QW intravenously) Receives: Drug: Paclitaxel |
| MM-121 (SAR256212) + Paclitaxel | Experimental | administered intravenously at 40 mg/kg loading dose on Cycle 1, Week 1 followed by 20 mg/kg QW for all subsequent doses Receives: Drug: MM-121; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
To determine whether MM-121 + paclitaxel was more effective than paclitaxel alone in prolonging progression-free survival in advanced ovarian cancers resistant or refractory to platinum agents. PFS was a time to event measure, and progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), "as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions". Progression free survival was defined as the number of months from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD).
Measured: Time from first dose to date of progression, the longest time frame of 3.9 years
Secondary outcomes (1)
Overall Survival
To determine whether MM-121 + paclitaxel is more effective than paclitaxel alone in prolonging overall survival. This was a time-to-event analysis of time from first dose to date of death.
Measured: Time from first dose to date of death, with a median of approximately 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionSep 2013
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epithelial Ovarian 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merrimack Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Victor Moyo, MD, Study director, Merrimack Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447706
- Sponsor's protocol ID
- MM-121-04-02-08 (ARD11586)
- Status last verified
- Apr 2016
- First submitted
- 3 Oct 2011
- Last updated
- 12 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Liu JF, Ray-Coquard I, Selle F, Poveda AM, Cibula D, Hirte H, Hilpert F, Raspagliesi F, Gladieff L, Harter P, Siena S, Del Campo JM, Tabah-Fisch I, Pearlberg J, Moyo V, Riahi K, Nering R, Kubasek W, Adiwijaya B, Czibere A, Naumann RW, Coleman RL, Vergote I, MacBeath G, Pujade-Lauraine E. Randomized Phase II Trial of Seribantumab in Combination With Paclitaxel in Patients With Advanced Platinum-Resistant or -Refractory Ovarian Cancer. J Clin Oncol. 2016 Dec 20;34(36):4345-4353. doi: 10.1200/JCO.2016.67.1891. Epub 2016 Oct 23.
PubMed 27998236
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Open Label Study of MM-121 in Combination With Paclitaxel Versus Paclitaxel Alone in Patients With Platinum Resistant/ Refractory Advanced Ovarian Cancers
- ClinicalTrials.gov ID
- NCT01447706
- Acronym / sponsor ID
- MM-121-04-02-08 (ARD11586)
- Keywords
- Ovarian Cancer, Platinum-resistant, Platinum-refractory, Fallopian tube cancer, Peritoneal Cancer, Paclitaxel, ErbB3, Phase II
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Merrimack PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Oct 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 6 Oct 2011 (estimated)
- Results
- Posted 12 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine whether the combination of MM-121 plus paclitaxel is more effective than paclitaxel alone
Detailed description
This is a multicenter, open-label, randomized, Phase II study of MM-121 in patients with platinum resistant or refractory recurrent/advanced ovarian cancers. Up to 210 patients will be randomized (2:1) to receive MM-121 plus paclitaxel or paclitaxel alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel | Active comparator | Drug: PaclitaxelStandard dosing paclitaxel: 80 mg/m2 QW intravenously) |
| MM-121 (SAR256212) + Paclitaxel | Experimental | Drug: MM-121, Drug: Paclitaxeladministered intravenously at 40 mg/kg loading dose on Cycle 1, Week 1 followed by 20 mg/kg QW for all subsequent doses |
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)
- Locally advanced/metastatic or recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
- Received at least one prior platinum based chemotherapy regimen
- Platinum-resistant or refractory
- Eligible for weekly paclitaxel
- Adequate liver and kidney function
Key exclusion criteria (2 listed)
- Evidence of any other active malignancy
- History of severe allergic reactions to paclitaxel or other drugs formulated in Cremophor®EL
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 |
|---|---|---|
| MM-121Also: SAR256212MM-121 (SAR256212) (IV) | Drug | MM-121 (SAR256212) + Paclitaxel |
| PaclitaxelStandard dosing Paclitaxel (IV) | Drug | MM-121 (SAR256212) + Paclitaxel, Paclitaxel |
Primary outcome
Progression Free Survival
Time frame: Time from first dose to date of progression, the longest time frame of 3.9 years
To determine whether MM-121 + paclitaxel was more effective than paclitaxel alone in prolonging progression-free survival in advanced ovarian cancers resistant or refractory to platinum agents. PFS was a time to event measure, and progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), "as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions". Progression free survival was defined as the number of months from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD).
1 secondary outcome
Overall Survival
Time frame: Time from first dose to date of death, with a median of approximately 13 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27998236Liu JF, Ray-Coquard I, Selle F, Poveda AM, Cibula D, Hirte H, Hilpert F, Raspagliesi F, Gladieff L, Harter P, Siena S, Del Campo JM, Tabah-Fisch I, Pearlberg J, Moyo V, Riahi K, Nering R, Kubasek W, Adiwijaya B, Czibere A, Naumann RW, Coleman RL, Vergote I, MacBeath G, Pujade-Lauraine E. Randomized Phase II Trial of Seribantumab in Combination With Paclitaxel in Patients With Advanced Platinum-Resistant or -Refractory Ovarian Cancer. J Clin Oncol. 2016 Dec 20;34(36):4345-4353. doi: 10.1200/JCO.2016.67.1891. Epub 2016 Oct 23.
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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.
Victor Moyo, MD study director
Merrimack Pharmaceuticals
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MM-121 and Paclitaxel in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Merrimack Pharmaceuticals at 10 sites 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 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 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 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?
Yes. Results are posted in the registry (first posted 12 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: Time from first dose to date of progression, the longest time frame of 3.9 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 NCT01447706, 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 12 May 2016.