Trial · NCT01209195
A Study of MM-121 in Combination With Paclitaxel in Patients With Advanced Gynecologic and Breast Cancers
NCT01209195, Phase 1, Completed, Merrimack Pharmaceuticals; results first posted 2016-09-08
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of MM-121 in Combination With Paclitaxel in Patients With Advanced Gynecologic and Breast Cancers. Trials, record NCT01209195. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01209195
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of MM-121 in Combination With Paclitaxel in Patients With Advanced Gynecologic and Breast Cancers
- NCT number
- NCT01209195
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 41 participants, actual
- Lead sponsor
- Merrimack Pharmaceuticals
- Conditions
- Locally Advanced/Metastatic or Recurrent Ovarian Cancer, Fallopian Tube Cancer,, Primary Peritoneal Cancer or Endometrial Cancer, Locally Advanced/Metastatic Her2 Non Overexpressing Breast Cancer
- Interventions
- MM-121, Paclitaxel
- First posted
- 2010-09-27
- Last updated
- 2016-09-08
- Results first posted
- 2016-09-08
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Paclitaxel Combination Via Reporting of Dose-limiting Toxicity (DLT) | From date of first dose to 30 days after termination, the longest 163 weeks | To establish the safety of escalating doses of MM-121 in combination with paclitaxel in order to determine the recommended phase 2 dose. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD. |
| Primary | To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Paclitaxel: MM-121 Dose Level | From date of first dose to 30 days after termination, the longest 163 weeks | Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort. Part 1 Cohort 1: MM-121: 20 mg/kg loading dose followed by 12 mg/kg QW IV )20/12) + Paclitaxel: 80mg/m2 IV QW Part 1 Cohort 2: MM-121: 40 mg/kg loading dose followed by 20 mg/kg QW IV (40/20) + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 1: MM-121: 40/20 mg/kg IV + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 2: MM-121 20 /12 mg/kg IV QW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 3: MM-121 40mg/kg IV QOW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 4: MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest + Paclitaxel: 80mg/m2 weekly IV for 3 weeks, followed by one week of rest |
| Primary | To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Paclitaxel: Paclitaxel Dose Level | From date of first dose to 30 days after termination, the longest 163 weeks | Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort. Part 1 Cohort 1: MM-121: 20 mg/kg loading dose followed by 12 mg/kg QW IV )20/12) + Paclitaxel: 80mg/m2 IV QW Part 1 Cohort 2: MM-121: 40 mg/kg loading dose followed by 20 mg/kg QW IV (40/20) + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 1: MM-121: 40/20 mg/kg IV + Paclitaxel: 80mg/m2 QW IV Part 2 Cohort 2: MM-121 20 /12 mg/kg IV QW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 3: MM-121 40mg/kg IV QOW + Paclitaxel: 80 mg/m2 QW IV Part 2 Cohort 4: MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest + Paclitaxel: 80mg/m2 weekly IV for 3 weeks, followed by one week of rest |
| Secondary | To Characterize the Efficacy of the Combination of MM-121 and Paclitaxel Using Objective Response Rate | patients were assessed for response during their time on study, the longest of which was 163 weeks | To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response (PR) is defined as \>20% decrease in tumor burden from baseline and a Complete Response (CR) is defined as complete disappearance from tumor burden from baseline. Objective Response is presented as the total # patients with PR or CR. |
| Secondary | To Determine the Pharmacokinetics (PK) of MM-121 When Administered in Combination With Paclitaxel | Collections taken at for all patients at Cycle 1, Week 1 (pre-treatment/pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121) and pre-treatment at Cycle 1, Week 3 and Cycle 2, Week 1 | Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the maximum observed concentration (Cmax). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (20/12 mg/kg weekly, 40/20 mg/kg weekly, 40 mg/kg Q2W, or 40/20 mg/kg QW x 7 plus a rest week). |
| Secondary | Pharmacokinetic Parameters (AUClast) | Collections taken at for all patients at Cycle 1, Week 1 (pre-treatment/pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121) and pre-treatment at Cycle 1, Week 3 and Cycle 2, Week 1 | Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the maximum observed concentration (Cmax). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (20/12 mg/kg weekly, 40/20 mg/kg weekly, 40 mg/kg Q2W, or 40/20 mg/kg QW x 7 plus a rest week). Immunogenicity data is not available. |
| Secondary | Immunogenicity | Samples were collected for all patients pre-dose on all cycles for duration of treatment, the longest of which was 163 weeks, and a collection was made post-infusion in any case of infusion reaction | Samples were collected to determine the presence of an immunologic reaction to MM-121 (i.e. human anti-human antibodies). |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Paclitaxel Combination Via Reporting of Dose-limiting Toxicity (DLT) | From date of first dose to 30 days after termination, the longest 163 weeks | participants reporting DLTs | NUMBER | |
| PRIMARY | To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Paclitaxel: MM-121 Dose Level | From date of first dose to 30 days after termination, the longest 163 weeks | NOTE: MTD of paclitaxel when administered with MM-121 provided in separate endpoint entry | mg/kg | NUMBER |
| PRIMARY | To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Paclitaxel: Paclitaxel Dose Level | From date of first dose to 30 days after termination, the longest 163 weeks | note: MTD of MM-121 when administered in combination with paclitaxel provided in separate endpoint entry | mg/m2 | NUMBER |
| SECONDARY | To Characterize the Efficacy of the Combination of MM-121 and Paclitaxel Using Objective Response Rate | patients were assessed for response during their time on study, the longest of which was 163 weeks | participants with objective response | NUMBER | |
| SECONDARY | To Determine the Pharmacokinetics (PK) of MM-121 When Administered in Combination With Paclitaxel | Collections taken at for all patients at Cycle 1, Week 1 (pre-treatment/pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121) and pre-treatment at Cycle 1, Week 3 and Cycle 2, Week 1 | All patients. Data presented per dose level of MM-121 and not per cohort. The same dose was used in multiple cohorts, and those data were combined.~NOTE: two patients are not included in the analysis due to incorrectly collected or processed samples. | ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetic Parameters (AUClast) | Collections taken at for all patients at Cycle 1, Week 1 (pre-treatment/pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121) and pre-treatment at Cycle 1, Week 3 and Cycle 2, Week 1 | All patients. Data presented per dose level of MM-121 and not per cohort. The same dose was used in multiple cohorts, and those data were combined.~NOTE: two patients are not included in the analysis due to incorrectly collected or processed samples. | hr* ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Immunogenicity | Samples were collected for all patients pre-dose on all cycles for duration of treatment, the longest of which was 163 weeks, and a collection was made post-infusion in any case of infusion reaction | NUMBER |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Paclitaxel Combination Via Reporting of Dose-limiting Toxicity (DLT) | Part 1: Dose Escalation: Cohort 1 | 0 | participants reporting DLTs | ||
| Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Paclitaxel Combination Via Reporting of Dose-limiting Toxicity (DLT) | Part 1: Dose Escalation: Cohort 2 | 1 | participants reporting DLTs | ||
| Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Paclitaxel Combination Via Reporting of Dose-limiting Toxicity (DLT) | Part 2: Expansion Cohort 1 | 0 | participants reporting DLTs | ||
| Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Paclitaxel Combination Via Reporting of Dose-limiting Toxicity (DLT) | Part 2: Expansion Cohort 2 | 0 | participants reporting DLTs | ||
| Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Paclitaxel Combination Via Reporting of Dose-limiting Toxicity (DLT) | Part 2: Cohort 3 | 0 | participants reporting DLTs | ||
| Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Paclitaxel Combination Via Reporting of Dose-limiting Toxicity (DLT) | Part 2: Cohort 4 | 0 | participants reporting DLTs | ||
| To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Paclitaxel: MM-121 Dose Level | Part 1: Dose Escalation | one-time loading dose | 40 | mg/kg | |
| To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Paclitaxel: MM-121 Dose Level | Part 2: Expansion Cohorts | one-time loading dose | 40 | mg/kg | |
| To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Paclitaxel: MM-121 Dose Level | Part 1: Dose Escalation | maintenance dose | 20 | mg/kg | |
| To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Paclitaxel: MM-121 Dose Level | Part 2: Expansion Cohorts | maintenance dose | 20 | mg/kg |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1: Dose Escalation: Cohort 1 | 7 | |
| Overall Study | STARTED | Part 1: Dose Escalation: Cohort 2 | 3 | |
| Overall Study | STARTED | Part 2: Expansion Cohort 1 | 6 | |
| Overall Study | STARTED | Part 2: Expansion Cohort 2 | 6 | |
| Overall Study | STARTED | Part 2: Cohort 3 | 6 | |
| Overall Study | STARTED | Part 2: Cohort 4 | 13 | |
| Overall Study | COMPLETED | Part 1: Dose Escalation: Cohort 1 | 7 | |
| Overall Study | COMPLETED | Part 1: Dose Escalation: Cohort 2 | 3 | |
| Overall Study | COMPLETED | Part 2: Expansion Cohort 1 | 6 | |
| Overall Study | COMPLETED | Part 2: Expansion Cohort 2 | 6 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events362
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ABDOMINAL PAIN | Gastrointestinal disorders | MM-121 + Paclitaxel: Dose Escalation | 9 | 10 | |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | MM-121 + Paclitaxel: Expansion Cohort | 7 | 31 | |
| other | DIARRHOEA | Gastrointestinal disorders | MM-121 + Paclitaxel: Dose Escalation | 5 | 10 | |
| other | DIARRHOEA | Gastrointestinal disorders | MM-121 + Paclitaxel: Expansion Cohort | 18 | 31 | |
| other | STOMATITIS | Gastrointestinal disorders | MM-121 + Paclitaxel: Dose Escalation | 5 | 10 | |
| other | STOMATITIS | Gastrointestinal disorders | MM-121 + Paclitaxel: Expansion Cohort | 9 | 31 | |
| other | NAUSEA | Gastrointestinal disorders | MM-121 + Paclitaxel: Dose Escalation | 4 | 10 | |
| other | NAUSEA | Gastrointestinal disorders | MM-121 + Paclitaxel: Expansion Cohort | 13 | 31 | |
| other | SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MM-121 + Paclitaxel: Dose Escalation | 3 | 10 | |
| other | SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MM-121 + Paclitaxel: Expansion Cohort | 0 | 31 |
1 to 10 of 362Source ClinicalTrials.gov
See all 362 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MM-121 + Paclitaxel: Dose Escalation | ||
| Total, all-cause mortality | MM-121 + Paclitaxel: Expansion Cohort | ||
| Total, other adverse events | MM-121 + Paclitaxel: Dose Escalation | 10 | 10 |
| Total, other adverse events | MM-121 + Paclitaxel: Expansion Cohort | 31 | 31 |
| Total, serious adverse events | MM-121 + Paclitaxel: Dose Escalation | 4 | 10 |
| Total, serious adverse events | MM-121 + Paclitaxel: Expansion Cohort | 12 | 31 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| MM-121 + Paclitaxel: Dose Escalation vs MM-121 + Paclitaxel: Expansion Cohort: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01209195
GET https://conductscience.org/api/trials/v1/NCT01209195/results?page=2