A Phase 2 interventional study of MM-121 and Paclitaxel in Epithelial Ovarian Cancer, Fallopian Tube Cancer and Peritoneal Cancer, sponsored by Merrimack Pharmaceuticals. Completed at 10 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-12.
Sponsored by Merrimack Pharmaceuticals · Phase 2, Interventional, and Treatment
To determine whether the combination of MM-121 plus paclitaxel is more effective than paclitaxel alone
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 223 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Merrimack Pharmaceuticals is the lead sponsor of 24 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard dosing paclitaxel: 80 mg/m2 QW intravenously)
Drug: Paclitaxel
administered intravenously at 40 mg/kg loading dose on Cycle 1, Week 1 followed by 20 mg/kg QW for all subsequent doses
Drug: MM-121 · Drug: Paclitaxel
MM-121 (SAR256212) (IV)
Also known as: SAR256212
Standard dosing Paclitaxel (IV)
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).
Time frame: Time from first dose to date of progression, the longest time frame of 3.9 years
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.
Time frame: Time from first dose to date of death, with a median of approximately 13 months
| Milestone | MM-121 + Paclitaxel | Paclitaxel |
|---|---|---|
| Started | 140 | 83 |
| Completed | 140 | 80 |
| Not completed | 0 | 3 |
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).
| months | MM-121 + Paclitaxel | Paclitaxel |
|---|---|---|
| Progression Free Survival | 3.75 (3.48 to 4.63) | 3.68 (2.56 to 5.52) |
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.
| months | MM-121 + Paclitaxel | Paclitaxel |
|---|---|---|
| Overall Survival | 13.70 (8.77 to NA) | 10.12 (8.77 to NA) |
Fresh tumor samples were obtained from patients prior to enrollment and formalin-fixed for analysis. Samples were analyzed using RNA-ISH for the expression of the biomarker, heregulin. Progression-free survival was assessed using RECIST v 1.1 to determine whether patients whose tumors express HRG have a lower PFS than those whose tumors do not express HRG, and to assess whether the addition of MM-121 to Paclitaxel can increase PFS in HRG-high patients.
| months PFS | HRG High: MM-121 + Paclitaxel | HRG High: Paclitaxel | HRG Low: Paclitaxel | HRG Low: MM-121 + Paclitaxel |
|---|---|---|---|---|
| To Explore the Utility of an EGFR Family Receptor-ligand (Heregulin, HRG) as a Predictor of Response to MM-121 and /or Paclitaxel in Formalin Fixed (FFPE) Tumor Samples | 5.7 (3.7 to 7.4) | 3.5 (1.8 to NA) | 5.4 (3.6 to NA) | 3.5 (2.2 to 3.9) |
Collected over AEs were collected from a patient's first dose until 30 days after treatment termination. SAEs were collected from time of informed consent until 30 days after termination. If related, events could be reported at any time after termination.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MM-121 + Paclitaxel | — | 59/140 (42.1%) | 140/140 (100%) |
| Paclitaxel | — | 25/80 (31.3%) | 79/80 (98.8%) |
| Event | MM-121 + Paclitaxel | Paclitaxel |
|---|---|---|
| Disease ProgressionGeneral disorders | 8/140 | 1/80 |
| Intestinal ObstructionGastrointestinal disorders | 7/140 | 4/80 |
| PyrexiaGeneral disorders | 3/140 | 4/80 |
| Small Intestinal ObstructionGastrointestinal disorders | 3/140 | 3/80 |
| SubileusGastrointestinal disorders | 3/140 | 2/80 |
| Pleural EffusionRespiratory, thoracic and mediastinal disorders | 0/140 | 2/80 |
| Abdominal PainGastrointestinal disorders | 3/140 | 0/80 |
| AscitesGastrointestinal disorders | 3/140 | 0/80 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 3/140 | 1/80 |
| Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders | 3/140 | 0/80 |
| Event | MM-121 + Paclitaxel | Paclitaxel |
|---|---|---|
| DiarrheaGastrointestinal disorders | 103/140 | 34/80 |
| NauseaGastrointestinal disorders | 60/140 | 39/80 |
| FatigueGeneral disorders | 63/140 | 30/80 |
| AlopeciaSkin and subcutaneous tissue disorders | 53/140 | 26/80 |
| VomitingGastrointestinal disorders | 44/140 | 15/80 |
| AnemiaBlood and lymphatic system disorders | 39/140 | 24/80 |
| Abdominal painGastrointestinal disorders | 41/140 | 20/80 |
| ConstipationGastrointestinal disorders | 26/140 | 21/80 |
| PyrexiaGeneral disorders | 25/140 | 21/80 |
| Decreased appetiteMetabolism and nutrition disorders | 35/140 | 20/80 |
| Age, Continuous(years) | MM-121 + Paclitaxel | Paclitaxel | Total |
|---|---|---|---|
| Mean | 58.5 ± 10.53 | 60.6 ± 11.85 | 59.6 ± 11.19 |
| Sex: Female, Male(Participants) | MM-121 + Paclitaxel | Paclitaxel | Total |
|---|---|---|---|
| Female | 140 | 83 | 223 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | MM-121 + Paclitaxel | Paclitaxel | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 5 | 15 |
| Not Hispanic or Latino | 107 | 62 | 169 |
| Unknown or Not Reported | 23 | 16 | 39 |
| Race/Ethnicity, Customized(participants) | MM-121 + Paclitaxel | Paclitaxel | Total |
|---|---|---|---|
| White/Caucasian | 111 | 66 | 177 |
| Black or African American | 2 | 1 | 3 |
| Alaska Native or American Indian | 0 | 0 | 0 |
| Asian/Oriental | 1 | 2 | 3 |
| Native Hawaiian or Pacific Islander | 0 | 0 | 0 |
| Other | 18 | 8 | 26 |
| Data Not Reported | 8 | 6 | 14 |
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Merrimack Pharmaceuticals