SHERLOC: A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC
Sponsor
Elevation Oncology (Industry)
Overall Status
Terminated
CT.gov ID
NCT02387216
Collaborator
Merrimack Pharmaceuticals (Industry)
153
35
2
47
4.4
0.1
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether the combination of MM-121 plus docetaxel is more effective than docetaxel alone in regards to PFS in patients with heregulin-positive NSCLC.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
This study is a randomized, open-label, international, multi-center, phase 2 study in patients with Heregulin-positive NSCLC histologically classified as adenocarcinoma that have progressed following no more than two systemic therapies for locally advanced or metastatic disease, one of which must have been a platinum containing regimen. All patients will initially be screened for heregulin status. Eligible patients will be randomized to receive MM-121 in combination with docetaxel versus docetaxel alone.
Study Design
Study Type:
Interventional
Actual Enrollment
:
153 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Randomized, open-label, international, multi-center, Phase 2 study in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)Randomized, open-label, international, multi-center, Phase 2 study in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
SHERLOC: A Phase 2 Study of MM-121 in Combination With Docetaxel Versus Docetaxel Alone in Patients With Heregulin Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Merrimack Pharmaceuticals Inc.)
Actual Study Start Date
:
Feb 1, 2015
Actual Primary Completion Date
:
Jan 2, 2019
Actual Study Completion Date
:
Jan 2, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm A: Experimental Arm MM-121 in combination with Docetaxel |
Drug: MM-121
Investigational, fully human antibody targeting and inhibiting ErbB3
Other Names:
Drug: Docetaxel
approved chemotherapy treatment for NSCLC
Other Names:
|
| Active Comparator: Arm B: Comparator Arm Docetaxel alone |
Drug: Docetaxel
approved chemotherapy treatment for NSCLC
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Progression Free Survival [Randomization until progression of disease or death due to any cause within 3 years,11 months (the study terminated prematurely)]
Progression Free Survival is defined as the time from randomization to the first documented radiographical progression of disease using RECIST v.1.1, or death from any cause, whichever came first based on investigator assessment. Patients that do not experience progression or death at the time of analysis were to be progression censored at the date of last valid tumor assessment. Progression-free survival time distribution and median survival for each treatment group were analyzed using the Kaplan-Meier method. Tumor response was evaluated by the local radiologist according to RECIST version 1.1 to establish disease progression by CT or MRI.
Secondary Outcome Measures
- Overall Survival [From date of randomization until the date of death from any cause assessed upto 3 years,11 months (the study terminated prematurely)]
Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause
- Objective Response Rate [Randomization through end of study up to 3 years, 11 months (the study terminated prematurely)]
Objective Response Rate (ORR) is defined as the proportion of patients a best overall response characterised as either a Complete Response (CR) or Partial Response (PR), as defined according to RECIST v1.1 guidelines, relative to the total number of evaluable patients. Complete Response (CR) is defined as disappearance of all lesions and pathologic lymph nodes. Partial Response (PR) is defined as >=30% decrease in the sum of the longest diameter of target lesions
- Time to Progression [Randomization to date of objective tumor progression up to 3 years, 11 months (the study terminated prematurely)]
Time to Progression (TTP) is defined as the time from the date of randomization to the date of objective tumor progression. In the actual analysis, duration of response (DOR) was analysed.
- Number of Participants With Treatment-emergent Adverse Events Reported With the Combination of MM-121 With Docetaxel Versus Docetaxel Alone [TEAEs were collected through the study completion (02 Jan 2019), up to 3 years, 11 months]
Treatment-emergent adverse events (TEAEs) are defined as any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration
- Pharmacokinetic (PK) Parameters of MM-121 in Combination With Docetaxel and Docetaxel When Given in Combination With MM-121. [The study terminated prematurely after 3 years, 11 months (02 Jan 2019). PK evaluation were to be performed on samples obtained at Week 1 pre-dose and post-dose and at pre-dose at Cycle 2 and beyond to assess pre-treatment through concentrations of MM-121]
Pharmacokinetic (PK) profile of MM-121 when given in combination with docetaxel, and of docetaxel when given in combination with MM-121. The maximum observed concentration (Cmax) were to be presented and calculated using non-compartmental analysis. Serum levels of MM-121 were to be measured at a central lab using an enzyme-linked immunosorbent assay.
- Percentage of Participants With Treatment-emergent Adverse Events Reported With the Combination of MM-121 With Docetaxel Versus Docetaxel Alone [TEAEs were collected through the study completion (02 Jan 2019), up to 3 years, 11 months]
Treatment-emergent adverse events (TEAEs) are defined as any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients with a diagnosis of cytologically or histologically documented adenocarcinoma of the lung with either metastatic disease (stage IV), Stage IIIB or Stage IIIC disease not amenable to surgery with curative intent
-
Not received more than 2 prior systemic therapies- one of which must have been a platinum based regimen- for primary or recurrent disease
-
Tissue submitted for HRG-biomarker testing
-
ECOG performance status (PS) of 0 or 1
Exclusion Criteria:
-
Known ALK mutation
-
Presence of exon 19 deletion or exon 21 (L858R) substitution of the EGFR gene
-
Received >2 prior systemic anti-cancer drug regimen for locally advanced disease
-
Prior treatment with an anti-ErbB3 antibody
-
CTCAE grade 3 or higher peripheral neuropathy
-
Symptomatic CNS metastases or CNS metastases requiring steroids
-
Any other active malignancy requiring systemic therapy
-
Clinically significant cardiac disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tucson | Arizona | United States | 85715 | |
| 2 | Los Angeles | California | United States | 90033 | |
| 3 | Santa Rosa | California | United States | 95403 | |
| 4 | Tampa | Florida | United States | 33612 | |
| 5 | Chicago | Illinois | United States | 60611 | |
| 6 | Lafayette | Indiana | United States | 47905 | |
| 7 | Boston | Massachusetts | United States | 02114 | |
| 8 | Boston | Massachusetts | United States | 02215 | |
| 9 | Danvers | Massachusetts | United States | 01923 | |
| 10 | Bronx | New York | United States | 10461 | |
| 11 | New York | New York | United States | 10016 | |
| 12 | Philadelphia | Pennsylvania | United States | 19111 | |
| 13 | Pittsburgh | Pennsylvania | United States | 15224 | |
| 14 | Nashville | Tennessee | United States | 37203 | |
| 15 | Nashville | Tennessee | United States | 37232 | |
| 16 | Fairfax | Virginia | United States | 22031 | |
| 17 | Seattle | Washington | United States | 98101 | |
| 18 | Toronto | Ontario | Canada | M5G 2M9 | |
| 19 | CHI Creteil | Créteil | Paris | France | 94010 |
| 20 | Centre Léon Bérard | Lyon cedex 08 | Rhône-Alpes | France | 69317 |
| 21 | Munchen | Bayern | Germany | 80336 | |
| 22 | Bad Berka | Germany | 99437 | ||
| 23 | Berlin | Germany | 13353 | ||
| 24 | Frankfurt | Germany | 60488 | ||
| 25 | Oldenburg | Germany | 26121 | ||
| 26 | Budapest | Hungary | H-1121 | ||
| 27 | Miskolc | Hungary | H-3529 | ||
| 28 | Tatabanya | Hungary | H-2800 | ||
| 29 | Badalona | Barcelona | Spain | 08916 | |
| 30 | Majadahonda | Madrid | Spain | 28222 | |
| 31 | Barcelona | Spain | 08035 | ||
| 32 | Madrid | Spain | 28007 | ||
| 33 | Madrid | Spain | 28046 | ||
| 34 | Malaga | Spain | 29010 | ||
| 35 | Zaragoza | Spain | 50009 |
Sponsors and Collaborators
- Elevation Oncology
- Merrimack Pharmaceuticals
Investigators
- Study Director: MM-121 Program Medical Director, MD, Merrimack Pharmaceuticals
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Elevation Oncology
ClinicalTrials.gov Identifier:
NCT02387216
Other Study ID Numbers:
- MM-121-01-02-09
First Posted:
Mar 12, 2015
Last Update Posted:
Oct 12, 2021
Last Verified:
Oct 1, 2021
Keywords provided by Elevation Oncology
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 87 multi-national sites |
|---|---|
| Pre-assignment Detail | One patient was inappropriately enrolled into the sherloc study hence why 152 and not 153 |
| Arm/Group Title | Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone |
|---|---|---|
| Arm/Group Description | MM-121 (Seribantumab, a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): 3000 mg fixed dose intravenous (IV) on Day 1 of each 21-day cycle Docetaxel (approved chemotherapy treatment for non-small cell lung cancer (NSCLC)): 75 mg/m˄2 IV on Day 1 of each 21-day cycle | Docetaxel (approved chemotherapy treatment for NSCLC): 75 mg/m˄2 IV on Day 1 of each 21-day cycle |
| Period Title: Overall Study | ||
| STARTED | 103 | 49 |
| COMPLETED | 3 | 2 |
| NOT COMPLETED | 100 | 47 |
Baseline Characteristics
| Arm/Group Title | Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone | Total |
|---|---|---|---|
| Arm/Group Description | MM-121 (Seribantumab, a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): 3000 mg fixed dose intravenous (IV) on Day 1 of each 21-day cycle Docetaxel (approved chemotherapy treatment for non-small cell lung cancer (NSCLC)): 75 mg/m˄2 IV on Day 1 of each 21-day cycle | Docetaxel (approved chemotherapy treatment for NSCLC): 75 mg/m˄2 IV on Day 1 of each 21-day cycle | Total of all reporting groups |
| Overall Participants | 103 | 49 | 152 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
58
56.3%
|
31
63.3%
|
89
58.6%
|
| >=65 years |
45
43.7%
|
18
36.7%
|
63
41.4%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
62.6
(10.07)
|
62.8
(7.28)
|
62.8
(8.68)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
32
31.1%
|
19
38.8%
|
51
33.6%
|
| Male |
71
68.9%
|
30
61.2%
|
101
66.4%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
6
5.8%
|
4
8.2%
|
10
6.6%
|
| Not Hispanic or Latino |
90
87.4%
|
41
83.7%
|
131
86.2%
|
| Unknown or Not Reported |
7
6.8%
|
4
8.2%
|
11
7.2%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
10
9.7%
|
2
4.1%
|
12
7.9%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
2
1.9%
|
2
4.1%
|
4
2.6%
|
| White |
83
80.6%
|
38
77.6%
|
121
79.6%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
8
7.8%
|
7
14.3%
|
15
9.9%
|
| Region of Enrollment (participants) [Number] | |||
| Australia |
9
8.7%
|
3
6.1%
|
12
7.9%
|
| Canada |
2
1.9%
|
6
12.2%
|
8
5.3%
|
| France |
11
10.7%
|
6
12.2%
|
17
11.2%
|
| Germany |
7
6.8%
|
4
8.2%
|
11
7.2%
|
| Hungary |
1
1%
|
1
2%
|
2
1.3%
|
| Poland |
2
1.9%
|
2
4.1%
|
4
2.6%
|
| South Korea |
0
0%
|
1
2%
|
1
0.7%
|
| Spain |
28
27.2%
|
10
20.4%
|
38
25%
|
| Taiwan |
2
1.9%
|
1
2%
|
3
2%
|
| Thailand |
3
2.9%
|
0
0%
|
3
2%
|
| United States |
38
36.9%
|
15
30.6%
|
54
35.5%
|
| Metastatic burden (TNM Stage at Initial Diagnosis) (Count of Participants) | |||
| Stage IIA |
5
4.9%
|
3
6.1%
|
8
5.3%
|
| Stage IIB |
1
1%
|
1
2%
|
2
1.3%
|
| Stage IIIA |
7
6.8%
|
4
8.2%
|
11
7.2%
|
| Stage IIIB |
13
12.6%
|
8
16.3%
|
21
13.8%
|
| Stage IV |
77
74.8%
|
33
67.3%
|
110
72.4%
|
| Heregulin positive status and staining in archival tissue (Count of Participants) | |||
| Count of Participants [Participants] |
103
100%
|
49
100%
|
152
100%
|
Outcome Measures
| Title | Progression Free Survival |
|---|---|
| Description | Progression Free Survival is defined as the time from randomization to the first documented radiographical progression of disease using RECIST v.1.1, or death from any cause, whichever came first based on investigator assessment. Patients that do not experience progression or death at the time of analysis were to be progression censored at the date of last valid tumor assessment. Progression-free survival time distribution and median survival for each treatment group were analyzed using the Kaplan-Meier method. Tumor response was evaluated by the local radiologist according to RECIST version 1.1 to establish disease progression by CT or MRI. |
| Time Frame | Randomization until progression of disease or death due to any cause within 3 years,11 months (the study terminated prematurely) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Modified Intent-to-Treat (mITT) Population consisted of all randomized patients who received at least 1 dose of assigned therapy |
| Arm/Group Title | Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone |
|---|---|---|
| Arm/Group Description | MM-121 (Seribantumab, a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): 3000 mg fixed dose intravenous (IV) on Day 1 of each 21-day cycle Docetaxel (approved chemotherapy treatment for non-small cell lung cancer (NSCLC)): 75 mg/m˄2 IV on Day 1 of each 21-day cycle | Docetaxel (approved chemotherapy treatment for NSCLC): 75 mg/m˄2 IV on Day 1 of each 21-day cycle |
| Measure Participants | 71 | 38 |
| Median (Inter-Quartile Range) [months] |
3.4
|
4.1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm A (Experimental): MM-121 in Combination With Docetaxel, Arm B (Comparator): Docetaxel Alone |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2302 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.382 | |
| Confidence Interval |
(2-Sided) 95% 0.813 to 2.350 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Overall Survival |
|---|---|
| Description | Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause |
| Time Frame | From date of randomization until the date of death from any cause assessed upto 3 years,11 months (the study terminated prematurely) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified Intent-to-Treat (ITT) population |
| Arm/Group Title | Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone |
|---|---|---|
| Arm/Group Description | MM-121 (Seribantumab, a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): 3000 mg fixed dose intravenous (IV) on Day 1 of each 21-day cycle Docetaxel (approved chemotherapy treatment for non-small cell lung cancer (NSCLC)): 75 mg/m˄2 IV on Day 1 of each 21-day cycle | Docetaxel (approved chemotherapy treatment for NSCLC): 75 mg/m˄2 IV on Day 1 of each 21-day cycle |
| Measure Participants | 71 | 38 |
| Median (Inter-Quartile Range) [months] |
7.7
|
8.4
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm A (Experimental): MM-121 in Combination With Docetaxel, Arm B (Comparator): Docetaxel Alone |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5436 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.195 | |
| Confidence Interval |
(2-Sided) 95% 0.673 to 2.122 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Objective Response Rate |
|---|---|
| Description | Objective Response Rate (ORR) is defined as the proportion of patients a best overall response characterised as either a Complete Response (CR) or Partial Response (PR), as defined according to RECIST v1.1 guidelines, relative to the total number of evaluable patients. Complete Response (CR) is defined as disappearance of all lesions and pathologic lymph nodes. Partial Response (PR) is defined as >=30% decrease in the sum of the longest diameter of target lesions |
| Time Frame | Randomization through end of study up to 3 years, 11 months (the study terminated prematurely) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified Intent-to-Treat (ITT) population |
| Arm/Group Title | Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone |
|---|---|---|
| Arm/Group Description | MM-121 (Seribantumab, a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): 3000 mg fixed dose intravenous (IV) on Day 1 of each 21-day cycle Docetaxel (approved chemotherapy treatment for non-small cell lung cancer (NSCLC)): 75 mg/m˄2 IV on Day 1 of each 21-day cycle | Docetaxel (approved chemotherapy treatment for NSCLC): 75 mg/m˄2 IV on Day 1 of each 21-day cycle |
| Measure Participants | 71 | 38 |
| Objective Response |
14
13.6%
|
2
4.1%
|
| Partial Response (PR) |
14
13.6%
|
2
4.1%
|
| Stable Disease (SD) |
39
37.9%
|
26
53.1%
|
| Progressive Disease |
12
11.7%
|
5
10.2%
|
| Not Evaluable |
1
1%
|
1
2%
|
| No Evaluation |
5
4.9%
|
4
8.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm A (Experimental): MM-121 in Combination With Docetaxel, Arm B (Comparator): Docetaxel Alone |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0455 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 4.3 | |
| Confidence Interval |
(2-Sided) 95% to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Time to Progression |
|---|---|
| Description | Time to Progression (TTP) is defined as the time from the date of randomization to the date of objective tumor progression. In the actual analysis, duration of response (DOR) was analysed. |
| Time Frame | Randomization to date of objective tumor progression up to 3 years, 11 months (the study terminated prematurely) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified Intent-to-Treat Population |
| Arm/Group Title | Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone |
|---|---|---|
| Arm/Group Description | MM-121 (Seribantumab, a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): 3000 mg fixed dose intravenous (IV) on Day 1 of each 21-day cycle Docetaxel (approved chemotherapy treatment for non-small cell lung cancer (NSCLC)): 75 mg/m˄2 IV on Day 1 of each 21-day cycle | Docetaxel (approved chemotherapy treatment for NSCLC): 75 mg/m˄2 IV on Day 1 of each 21-day cycle |
| Measure Participants | 71 | 38 |
| Median (Inter-Quartile Range) [months] |
3.0
|
NA
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm A (Experimental): MM-121 in Combination With Docetaxel, Arm B (Comparator): Docetaxel Alone |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2726 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Title | Number of Participants With Treatment-emergent Adverse Events Reported With the Combination of MM-121 With Docetaxel Versus Docetaxel Alone |
|---|---|
| Description | Treatment-emergent adverse events (TEAEs) are defined as any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration |
| Time Frame | TEAEs were collected through the study completion (02 Jan 2019), up to 3 years, 11 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone |
|---|---|---|
| Arm/Group Description | MM-121 (Seribantumab, a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): 3000 mg fixed dose intravenous (IV) on Day 1 of each 21-day cycle Docetaxel (approved chemotherapy treatment for non-small cell lung cancer (NSCLC)): 75 mg/m˄2 IV on Day 1 of each 21-day cycle | Docetaxel (approved chemotherapy treatment for NSCLC): 75 mg/m˄2 IV on Day 1 of each 21-day cycle |
| Measure Participants | 103 | 49 |
| Patients with any TEAE-Related |
99
96.1%
|
45
91.8%
|
| Patients with any TEAE-Serious Adverse event |
40
38.8%
|
15
30.6%
|
| Patients with any NCI-CTCAE Grade 3 or Higher |
76
73.8%
|
31
63.3%
|
| Title | Pharmacokinetic (PK) Parameters of MM-121 in Combination With Docetaxel and Docetaxel When Given in Combination With MM-121. |
|---|---|
| Description | Pharmacokinetic (PK) profile of MM-121 when given in combination with docetaxel, and of docetaxel when given in combination with MM-121. The maximum observed concentration (Cmax) were to be presented and calculated using non-compartmental analysis. Serum levels of MM-121 were to be measured at a central lab using an enzyme-linked immunosorbent assay. |
| Time Frame | The study terminated prematurely after 3 years, 11 months (02 Jan 2019). PK evaluation were to be performed on samples obtained at Week 1 pre-dose and post-dose and at pre-dose at Cycle 2 and beyond to assess pre-treatment through concentrations of MM-121 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The PK data were not collected for this abbreviated report. There was no pharmacokinetic data feasible for the analysis, and as such, no related analyses were performed. Hence, data could not be reported in the data table. |
| Arm/Group Title | Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone |
|---|---|---|
| Arm/Group Description | MM-121 (Seribantumab, a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): 3000 mg fixed dose intravenous (IV) on Day 1 of each 21-day cycle Docetaxel (approved chemotherapy treatment for non-small cell lung cancer (NSCLC)): 75 mg/m˄2 IV on Day 1 of each 21-day cycle | Docetaxel (approved chemotherapy treatment for NSCLC): 75 mg/m˄2 IV on Day 1 of each 21-day cycle |
| Measure Participants | 0 | 0 |
| Title | Percentage of Participants With Treatment-emergent Adverse Events Reported With the Combination of MM-121 With Docetaxel Versus Docetaxel Alone |
|---|---|
| Description | Treatment-emergent adverse events (TEAEs) are defined as any event that occurred after the first dose of study drug and was not present prior to study drug administration or worsened in severity after study drug administration |
| Time Frame | TEAEs were collected through the study completion (02 Jan 2019), up to 3 years, 11 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone |
|---|---|---|
| Arm/Group Description | MM-121 (Seribantumab, a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): 3000 mg fixed dose intravenous (IV) on Day 1 of each 21-day cycle Docetaxel (approved chemotherapy treatment for non-small cell lung cancer (NSCLC)): 75 mg/m˄2 IV on Day 1 of each 21-day cycle | Docetaxel (approved chemotherapy treatment for NSCLC): 75 mg/m˄2 IV on Day 1 of each 21-day cycle |
| Measure Participants | 103 | 49 |
| TEAE-Related |
96.1
93.3%
|
91.8
187.3%
|
| TEAE-Serious Adverse event |
38.8
37.7%
|
30.6
62.4%
|
| NCI-CTCAE Grade 3 or Higher |
73.8
71.7%
|
63.3
129.2%
|
Adverse Events
| Time Frame | From Baseline through to premature study completion up to 3 years, 11 months (02 Jan 2019) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | The safety population includes patients receiving at least one dose of study medication. All safety analyses were be performed on this population. Safety analyses (adverse events and laboratory analyses) were performed using the safety population. Adverse events were coded using the latest MedDRA dictionary (MedDRA 21.0). Severity of adverse events was graded according to the NCI CTCAE version 4.03. | |||
| Arm/Group Title | Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone | ||
| Arm/Group Description | MM-121 (Seribantumab, a human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner): 3000 mg fixed dose intravenous (IV) on Day 1 of each 21-day cycle Docetaxel (approved chemotherapy treatment for non-small cell lung cancer (NSCLC)): 75 mg/m˄2 IV on Day 1 of each 21-day cycle | Docetaxel (approved chemotherapy treatment for NSCLC): 75 mg/m˄2 IV on Day 1 of each 21-day cycle | ||
All Cause Mortality |
||||
| Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 64/103 (62.1%) | 25/49 (51%) | ||
Serious Adverse Events |
||||
| Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 40/103 (38.8%) | 15/49 (30.6%) | ||
| Blood and lymphatic system disorders | ||||
| Febrile neutropenia | 7/103 (6.8%) | 4/49 (8.2%) | ||
| Anaemia | 2/103 (1.9%) | 1/49 (2%) | ||
| Neutropenia | 1/103 (1%) | 1/49 (2%) | ||
| Cardiac disorders | ||||
| Atrial flutter | 1/103 (1%) | 0/49 (0%) | ||
| Cardio pulmonary failure | 1/103 (1%) | 0/49 (0%) | ||
| Tachycardia | 1/103 (1%) | 0/49 (0%) | ||
| Atrial fibrillation | 0/103 (0%) | 1/49 (2%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 6/103 (5.8%) | 0/49 (0%) | ||
| Colitis | 3/103 (2.9%) | 0/49 (0%) | ||
| Gastrointestinal haemorrhage | 1/103 (1%) | 0/49 (0%) | ||
| Small intestinal obstruction | 1/103 (1%) | 0/49 (0%) | ||
| Neutropenic colitis | 0/103 (0%) | 1/49 (2%) | ||
| General disorders | ||||
| Pyrexia | 3/103 (2.9%) | 0/49 (0%) | ||
| Chest pain | 1/103 (1%) | 0/49 (0%) | ||
| Fatigue | 1/103 (1%) | 0/49 (0%) | ||
| Mucosal inflammation | 1/103 (1%) | 0/49 (0%) | ||
| General physical health deterioration | 0/103 (0%) | 1/49 (2%) | ||
| Hepatobiliary disorders | ||||
| Cholecystitis | 0/103 (0%) | 1/49 (2%) | ||
| Cholecystitis acute | 0/103 (0%) | 1/49 (2%) | ||
| Infections and infestations | ||||
| Pneumonia | 8/103 (7.8%) | 1/49 (2%) | ||
| Sepsis | 1/103 (1%) | 2/49 (4.1%) | ||
| Appendicitis | 1/103 (1%) | 0/49 (0%) | ||
| Bronchitis | 1/103 (1%) | 0/49 (0%) | ||
| Clostridium difficile infection | 1/103 (1%) | 0/49 (0%) | ||
| Diverticulitis | 1/103 (1%) | 0/49 (0%) | ||
| Listeriosis | 1/103 (1%) | 0/49 (0%) | ||
| Lower respiratory tract infection | 1/103 (1%) | 0/49 (0%) | ||
| Lung abscess | 1/103 (1%) | 0/49 (0%) | ||
| Pneumocystis jirovecii pneumonia | 1/103 (1%) | 0/49 (0%) | ||
| Septic shock | 1/103 (1%) | 0/49 (0%) | ||
| Device related infection | 0/103 (0%) | 1/49 (2%) | ||
| Influenza | 0/103 (0%) | 1/49 (2%) | ||
| Respiratory tract infection | 0/103 (0%) | 1/49 (2%) | ||
| Investigations | ||||
| Lipase increased | 1/103 (1%) | 0/49 (0%) | ||
| Neutrophil count decreased | 1/103 (1%) | 0/49 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 1/103 (1%) | 0/49 (0%) | ||
| Starvation | 1/103 (1%) | 0/49 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Pathological fracture | 1/103 (1%) | 0/49 (0%) | ||
| Psychiatric disorders | ||||
| Delirium | 1/103 (1%) | 0/49 (0%) | ||
| Depression | 1/103 (1%) | 0/49 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Respiratory failure | 2/103 (1.9%) | 0/49 (0%) | ||
| Pleural effusion | 1/103 (1%) | 1/49 (2%) | ||
| Acute respiratory failure | 1/103 (1%) | 0/49 (0%) | ||
| Hypoxia | 1/103 (1%) | 0/49 (0%) | ||
| Chronic obstructive pulmonary disease | 0/103 (0%) | 1/49 (2%) | ||
| Pneumonitis | 0/103 (0%) | 1/49 (2%) | ||
| Vascular disorders | ||||
| Deep vein thrombosis | 1/103 (1%) | 0/49 (0%) | ||
| Orthostatic hypotension | 1/103 (1%) | 0/49 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Arm A (Experimental): MM-121 in Combination With Docetaxel | Arm B (Comparator): Docetaxel Alone | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 103/103 (100%) | 47/49 (95.9%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 29/103 (28.2%) | 11/49 (22.4%) | ||
| Neutropenia | 29/103 (28.2%) | 11/49 (22.4%) | ||
| Febrile neutropenia | 8/103 (7.8%) | 6/49 (12.2%) | ||
| Leukopenia | 6/103 (5.8%) | 4/49 (8.2%) | ||
| Lymphopenia | 1/103 (1%) | 0/49 (0%) | ||
| Thrombocytopenia | 1/103 (1%) | 2/49 (4.1%) | ||
| Leukocytosis | 0/103 (0%) | 2/49 (4.1%) | ||
| Cardiac disorders | ||||
| Tachycardia | 4/103 (3.9%) | 0/49 (0%) | ||
| Sinus tachycardia | 3/103 (2.9%) | 2/49 (4.1%) | ||
| Atrial flutter | 2/103 (1.9%) | 0/49 (0%) | ||
| Cardio pulmonary failure | 1/103 (1%) | 0/49 (0%) | ||
| Myocardial infarction | 1/103 (1%) | 0/49 (0%) | ||
| Supraventricular tachycardia | 1/103 (1%) | 0/49 (0%) | ||
| Atrial fibrillation | 0/103 (0%) | 1/49 (2%) | ||
| Cardiac failure | 0/103 (0%) | 1/49 (2%) | ||
| Ear and labyrinth disorders | ||||
| Ear pain | 2/103 (1.9%) | 0/49 (0%) | ||
| Tinnitus | 2/103 (1.9%) | 0/49 (0%) | ||
| Hypoacusis | 1/103 (1%) | 0/49 (0%) | ||
| Vertigo | 0/103 (0%) | 1/49 (2%) | ||
| Endocrine disorders | ||||
| Hypothyroidism | 1/103 (1%) | 0/49 (0%) | ||
| Cushingoid | 0/103 (0%) | 1/49 (2%) | ||
| Eye disorders | ||||
| Lacrimation increased | 7/103 (6.8%) | 4/49 (8.2%) | ||
| Dry eye | 3/103 (2.9%) | 0/49 (0%) | ||
| Blepharospasm | 2/103 (1.9%) | 0/49 (0%) | ||
| Eye irritation | 2/103 (1.9%) | 0/49 (0%) | ||
| Vision blurred | 2/103 (1.9%) | 0/49 (0%) | ||
| Eye pruritus | 1/103 (1%) | 0/49 (0%) | ||
| Ocular hyperaemia | 0/103 (0%) | 1/49 (2%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 52/103 (50.5%) | 11/49 (22.4%) | ||
| Nausea | 30/103 (29.1%) | 14/49 (28.6%) | ||
| Stomatitis | 19/103 (18.4%) | 2/49 (4.1%) | ||
| Vomiting | 13/103 (12.6%) | 4/49 (8.2%) | ||
| Constipation | 7/103 (6.8%) | 7/49 (14.3%) | ||
| Dyspepsia | 6/103 (5.8%) | 2/49 (4.1%) | ||
| Dry mouth | 5/103 (4.9%) | 0/49 (0%) | ||
| Abdominal pain | 4/103 (3.9%) | 2/49 (4.1%) | ||
| Gastrooesophageal reflux disease | 3/103 (2.9%) | 3/49 (6.1%) | ||
| Haemorrhoids | 3/103 (2.9%) | 1/49 (2%) | ||
| Abdominal discomfort | 3/103 (2.9%) | 0/49 (0%) | ||
| Colitis | 3/103 (2.9%) | 3/49 (6.1%) | ||
| Flatulence | 3/103 (2.9%) | 0/49 (0%) | ||
| Abdominal pain lower | 2/103 (1.9%) | 3/49 (6.1%) | ||
| Gastrointestinal haemorrhage | 2/103 (1.9%) | 0/49 (0%) | ||
| Odynophagia | 2/103 (1.9%) | 0/49 (0%) | ||
| Oesophagitis | 2/103 (1.9%) | 0/49 (0%) | ||
| Aphthous stomatitis | 1/103 (1%) | 0/49 (0%) | ||
| Abdominal pain upper | 1/103 (1%) | 2/49 (4.1%) | ||
| Dysphagia | 1/103 (1%) | 1/49 (2%) | ||
| Oral pain | 1/103 (1%) | 1/49 (2%) | ||
| Small intestinal obstruction | 1/103 (1%) | 1/49 (2%) | ||
| Anal fissure | 1/103 (1%) | 0/49 (0%) | ||
| Anal haemorrhage | 1/103 (1%) | 0/49 (0%) | ||
| Anal inflammation | 1/103 (1%) | 0/49 (0%) | ||
| Duodenitis | 1/103 (1%) | 0/49 (0%) | ||
| Faeces discoloured | 1/103 (1%) | 0/49 (0%) | ||
| Gastritis | 1/103 (1%) | 0/49 (0%) | ||
| Glossodynia | 1/103 (1%) | 0/49 (0%) | ||
| Pancreatitis | 1/103 (1%) | 0/49 (0%) | ||
| Glossitis | 1/103 (1%) | 0/49 (0%) | ||
| Oral dysaesthesia | 1/103 (1%) | 0/49 (0%) | ||
| Rectal haemorrhage | 0/103 (0%) | 2/49 (4.1%) | ||
| Neutropenic colitis | 0/103 (0%) | 1/49 (2%) | ||
| Rectal tenesmus | 0/103 (0%) | 1/49 (2%) | ||
| Mucosal inflammation | 15/103 (14.6%) | 5/49 (10.2%) | ||
| General disorders | ||||
| Fatigue | 45/103 (43.7%) | 16/49 (32.7%) | ||
| Asthenia | 28/103 (27.2%) | 11/49 (22.4%) | ||
| Pyrexia | 13/103 (12.6%) | 9/49 (18.4%) | ||
| Pain | 8/103 (7.8%) | 6/49 (12.2%) | ||
| Oedema peripheral | 5/103 (4.9%) | 3/49 (6.1%) | ||
| Chills | 4/103 (3.9%) | 0/49 (0%) | ||
| Chest pain | 3/103 (2.9%) | 1/49 (2%) | ||
| General physical health deterioration | 3/103 (2.9%) | 1/49 (2%) | ||
| Oedema | 2/103 (1.9%) | 5/49 (10.2%) | ||
| Non-cardiac chest pain | 2/103 (1.9%) | 0/49 (0%) | ||
| Xerosis | 2/103 (1.9%) | 0/49 (0%) | ||
| Ulcer | 1/103 (1%) | 1/49 (2%) | ||
| Cyst | 1/103 (1%) | 0/49 (0%) | ||
| Extravasation | 1/103 (1%) | 0/49 (0%) | ||
| Hernia pain | 1/103 (1%) | 0/49 (0%) | ||
| Hyperthermia | 1/103 (1%) | 0/49 (0%) | ||
| Influenza like illness | 1/103 (1%) | 0/49 (0%) | ||
| Infusion site reaction | 1/103 (1%) | 0/49 (0%) | ||
| Gait disturbance | 1/103 (1%) | 0/49 (0%) | ||
| Discomfort | 0/103 (0%) | 1/49 (2%) | ||
| Local swelling | 0/103 (0%) | 1/49 (2%) | ||
| Secretion discharge | 0/103 (0%) | 1/49 (2%) | ||
| Hepatobiliary disorders | ||||
| Cholecystitis | 1/103 (1%) | 0/49 (0%) | ||
| Cholecystitis acute | 0/103 (0%) | 1/49 (2%) | ||
| Cholelithiasis | 0/103 (0%) | 1/49 (2%) | ||
| Immune system disorders | ||||
| Seasonal allergy | 1/103 (1%) | 0/49 (0%) | ||
| Infections and infestations | ||||
| Pneumonia | 12/103 (11.7%) | 6/49 (12.2%) | ||
| Upper respiratory tract infection | 8/103 (7.8%) | 0/49 (0%) | ||
| Respiratory tract infection | 6/103 (5.8%) | 3/49 (6.1%) | ||
| Urinary tract infection | 4/103 (3.9%) | 0/49 (0%) | ||
| Lower respiratory tract infection | 3/103 (2.9%) | 1/49 (2%) | ||
| Oral candidiasis | 3/103 (2.9%) | 3/49 (6.1%) | ||
| Sepsis | 2/103 (1.9%) | 2/49 (4.1%) | ||
| Bronchitis | 2/103 (1.9%) | 1/49 (2%) | ||
| Candida infection | 2/103 (1.9%) | 1/49 (2%) | ||
| Conjunctivitis | 2/103 (1.9%) | 0/49 (0%) | ||
| Herpes zoster | 2/103 (1.9%) | 0/49 (0%) | ||
| Paronychia | 2/103 (1.9%) | 1/49 (2%) | ||
| Oral herpes | 2/103 (1.9%) | 0/49 (0%) | ||
| Clostridium difficile infection | 1/103 (1%) | 1/49 (2%) | ||
| Fungal infection | 1/103 (1%) | 1/49 (2%) | ||
| Influenza | 1/103 (1%) | 1/49 (2%) | ||
| Rhinitis | 1/103 (1%) | 1/49 (2%) | ||
| Appendicitis | 1/103 (1%) | 0/49 (0%) | ||
| Diverticulitis | 1/103 (1%) | 0/49 (0%) | ||
| Furuncle | 1/103 (1%) | 0/49 (0%) | ||
| Infection | 1/103 (1%) | 0/49 (0%) | ||
| Listeriosis | 1/103 (1%) | 0/49 (0%) | ||
| Lung abscess | 1/103 (1%) | 0/49 (0%) | ||
| Mucosal infection | 1/103 (1%) | 0/49 (0%) | ||
| Otitis media | 1/103 (1%) | 0/49 (0%) | ||
| Pneumocystis jirovecii pneumonia | 1/103 (1%) | 0/49 (0%) | ||
| Septic shock | 1/103 (1%) | 0/49 (0%) | ||
| Streptococcal bacteraemia | 1/103 (1%) | 0/49 (0%) | ||
| Tracheitis | 1/103 (1%) | 0/49 (0%) | ||
| Vaginal infection | 1/103 (1%) | 0/49 (0%) | ||
| Wound infection | 1/103 (1%) | 0/49 (0%) | ||
| Nasopharyngitis | 1/103 (1%) | 0/49 (0%) | ||
| Pharyngitis | 1/103 (1%) | 0/49 (0%) | ||
| Sinusitis | 1/103 (1%) | 0/49 (0%) | ||
| Device related infection | 0/103 (0%) | 1/49 (2%) | ||
| Ear infection | 0/103 (0%) | 1/49 (2%) | ||
| Laryngitis | 0/103 (0%) | 1/49 (2%) | ||
| Lymphangitis | 0/103 (0%) | 1/49 (2%) | ||
| Injury, poisoning and procedural complications | ||||
| Fall | 1/103 (1%) | 2/49 (4.1%) | ||
| Arthropod bite | 1/103 (1%) | 0/49 (0%) | ||
| Contusion | 1/103 (1%) | 0/49 (0%) | ||
| Incision site erythema | 1/103 (1%) | 0/49 (0%) | ||
| Pelvic fracture | 1/103 (1%) | 0/49 (0%) | ||
| Radiation pneumonitis | 1/103 (1%) | 0/49 (0%) | ||
| Radiation skin injury | 1/103 (1%) | 0/49 (0%) | ||
| Skin abrasion | 1/103 (1%) | 0/49 (0%) | ||
| Spinal fracture | 1/103 (1%) | 0/49 (0%) | ||
| Thermal burn | 1/103 (1%) | 0/49 (0%) | ||
| Investigations | ||||
| Neutrophil count decreased | 14/103 (13.6%) | 3/49 (6.1%) | ||
| White blood cell count decreased | 8/103 (7.8%) | 1/49 (2%) | ||
| Weight decreased | 7/103 (6.8%) | 4/49 (8.2%) | ||
| Blood creatinine increased | 3/103 (2.9%) | 1/49 (2%) | ||
| Alanine aminotransferase increased | 3/103 (2.9%) | 1/49 (2%) | ||
| Electrocardiogram QT prolonged | 3/103 (2.9%) | 0/49 (0%) | ||
| Haemoglobin decreased | 2/103 (1.9%) | 1/49 (2%) | ||
| Activated partial thromboplastin time prolonged | 2/103 (1.9%) | 1/49 (2%) | ||
| Aspartate aminotransferase increased | 2/103 (1.9%) | 0/49 (0%) | ||
| Blood alkaline phosphatase increased | 2/103 (1.9%) | 0/49 (0%) | ||
| Blood magnesium decreased | 2/103 (1.9%) | 0/49 (0%) | ||
| Lymphocyte count decreased | 2/103 (1.9%) | 0/49 (0%) | ||
| Platelet count decreased | 2/103 (1.9%) | 0/49 (0%) | ||
| Gamma-glutamyltransferase increased | 1/103 (1%) | 1/49 (2%) | ||
| Blood albumin decreased | 1/103 (1%) | 0/49 (0%) | ||
| Blood bilirubin increased | 1/103 (1%) | 0/49 (0%) | ||
| Blood glucose increased | 1/103 (1%) | 0/49 (0%) | ||
| Blood iron decreased | 1/103 (1%) | 0/49 (0%) | ||
| Blood phosphorus decreased | 1/103 (1%) | 0/49 (0%) | ||
| Blood sodium decreased | 1/103 (1%) | 0/49 (0%) | ||
| Breath sounds abnormal | 1/103 (1%) | 0/49 (0%) | ||
| International normalised ratio increased | 1/103 (1%) | 0/49 (0%) | ||
| Lipase increased | 1/103 (1%) | 0/49 (0%) | ||
| Transaminases increased | 1/103 (1%) | 0/49 (0%) | ||
| Urine analysis abnormal | 1/103 (1%) | 0/49 (0%) | ||
| Weight increased | 1/103 (1%) | 0/49 (0%) | ||
| Blood creatine increased | 0/103 (0%) | 1/49 (2%) | ||
| White blood cell count increased | 0/103 (0%) | 1/49 (2%) | ||
| Blood lactate dehydrogenase increased | 0/103 (0%) | 1/49 (2%) | ||
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 34/103 (33%) | 8/49 (16.3%) | ||
| Dehydration | 9/103 (8.7%) | 3/49 (6.1%) | ||
| Hypokalaemia | 7/103 (6.8%) | 5/49 (10.2%) | ||
| Hyponatraemia | 4/103 (3.9%) | 4/49 (8.2%) | ||
| Hypoalbuminaemia | 4/103 (3.9%) | 2/49 (4.1%) | ||
| Hypophosphataemia | 4/103 (3.9%) | 2/49 (4.1%) | ||
| Hypomagnesaemia | 4/103 (3.9%) | 0/49 (0%) | ||
| Hyperglycaemia | 3/103 (2.9%) | 3/49 (6.1%) | ||
| Hypocalcaemia | 2/103 (1.9%) | 1/49 (2%) | ||
| Hyperkalaemia | 1/103 (1%) | 1/49 (2%) | ||
| Gout | 1/103 (1%) | 0/49 (0%) | ||
| Hypernatraemia | 1/103 (1%) | 0/49 (0%) | ||
| Hypovitaminosis | 1/103 (1%) | 0/49 (0%) | ||
| Hypovolaemia | 1/103 (1%) | 0/49 (0%) | ||
| Starvation | 1/103 (1%) | 0/49 (0%) | ||
| Hypercalcaemia | 0/103 (0%) | 1/49 (2%) | ||
| Hypoglycaemia | 0/103 (0%) | 1/49 (2%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Myalgia | 8/103 (7.8%) | 3/49 (6.1%) | ||
| Back pain | 9/103 (8.7%) | 1/49 (2%) | ||
| Bone pain | 6/103 (5.8%) | 2/49 (4.1%) | ||
| Arthralgia | 6/103 (5.8%) | 2/49 (4.1%) | ||
| Musculoskeletal chest pain | 4/103 (3.9%) | 1/49 (2%) | ||
| Musculoskeletal pain | 3/103 (2.9%) | 2/49 (4.1%) | ||
| Muscular weakness | 3/103 (2.9%) | 0/49 (0%) | ||
| Pain in extremity | 2/103 (1.9%) | 4/49 (8.2%) | ||
| Neck pain | 1/103 (1%) | 2/49 (4.1%) | ||
| Muscle spasms | 1/103 (1%) | 1/49 (2%) | ||
| Limb discomfort | 1/103 (1%) | 0/49 (0%) | ||
| Pathological fracture | 1/103 (1%) | 0/49 (0%) | ||
| Spinal pain | 1/103 (1%) | 0/49 (0%) | ||
| Neck mass | 1/103 (1%) | 0/49 (0%) | ||
| Arthritis | 0/103 (0%) | 1/49 (2%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Seborrhoeic keratosis | 1/103 (1%) | 0/49 (0%) | ||
| Tumour pain | 1/103 (1%) | 0/49 (0%) | ||
| Tumour haemorrhage | 0/103 (0%) | 1/49 (2%) | ||
| Nervous system disorders | ||||
| Dizziness | 12/103 (11.7%) | 1/49 (2%) | ||
| Dysgeusia | 9/103 (8.7%) | 3/49 (6.1%) | ||
| Headache | 7/103 (6.8%) | 2/49 (4.1%) | ||
| Paraesthesia | 6/103 (5.8%) | 1/49 (2%) | ||
| Neuropathy peripheral | 4/103 (3.9%) | 3/49 (6.1%) | ||
| Peripheral sensory neuropathy | 3/103 (2.9%) | 0/49 (0%) | ||
| Syncope | 2/103 (1.9%) | 1/49 (2%) | ||
| Hemiparesis | 2/103 (1.9%) | 0/49 (0%) | ||
| Hypoaesthesia | 2/103 (1.9%) | 0/49 (0%) | ||
| Memory impairment | 2/103 (1.9%) | 0/49 (0%) | ||
| Polyneuropathy | 2/103 (1.9%) | 0/49 (0%) | ||
| Neurotoxicity | 1/103 (1%) | 1/49 (2%) | ||
| Presyncope | 1/103 (1%) | 1/49 (2%) | ||
| Somnolence | 1/103 (1%) | 1/49 (2%) | ||
| Amnesia | 1/103 (1%) | 0/49 (0%) | ||
| Lethargy | 1/103 (1%) | 0/49 (0%) | ||
| Paresis | 1/103 (1%) | 0/49 (0%) | ||
| Restless legs syndrome | 1/103 (1%) | 0/49 (0%) | ||
| Sciatica | 1/103 (1%) | 0/49 (0%) | ||
| Sinus headache | 1/103 (1%) | 0/49 (0%) | ||
| Spinal cord compression | 1/103 (1%) | 0/49 (0%) | ||
| Vocal cord paralysis | 1/103 (1%) | 0/49 (0%) | ||
| Ataxia | 1/103 (1%) | 1/49 (2%) | ||
| Cognitive disorder | 1/103 (1%) | 0/49 (0%) | ||
| Motor dysfunction | 1/103 (1%) | 0/49 (0%) | ||
| Encephalopathy | 0/103 (0%) | 1/49 (2%) | ||
| Psychiatric disorders | ||||
| Confusional state | 5/103 (4.9%) | 0/49 (0%) | ||
| Insomnia | 5/103 (4.9%) | 5/49 (10.2%) | ||
| Anxiety | 2/103 (1.9%) | 2/49 (4.1%) | ||
| Delirium | 2/103 (1.9%) | 0/49 (0%) | ||
| Agitation | 1/103 (1%) | 0/49 (0%) | ||
| Depression | 1/103 (1%) | 0/49 (0%) | ||
| Irritability | 1/103 (1%) | 0/49 (0%) | ||
| Sleep disorder | 1/103 (1%) | 0/49 (0%) | ||
| Anorexia nervosa | 0/103 (0%) | 1/49 (2%) | ||
| Renal and urinary disorders | ||||
| Renal failure | 2/103 (1.9%) | 0/49 (0%) | ||
| Haematuria | 1/103 (1%) | 0/49 (0%) | ||
| Incontinence | 1/103 (1%) | 0/49 (0%) | ||
| Renal failure acute | 1/103 (1%) | 0/49 (0%) | ||
| Renal venous congestion | 1/103 (1%) | 0/49 (0%) | ||
| Urinary hesitation | 1/103 (1%) | 0/49 (0%) | ||
| Urinary retention | 1/103 (1%) | 0/49 (0%) | ||
| Hypertonic bladder | 1/103 (1%) | 0/49 (0%) | ||
| Pollakiuria | 1/103 (1%) | 0/49 (0%) | ||
| Reproductive system and breast disorders | ||||
| Bartholin's cyst | 1/103 (1%) | 0/49 (0%) | ||
| Vaginal inflammation | 1/103 (1%) | 0/49 (0%) | ||
| Vulvovaginal pain | 1/103 (1%) | 0/49 (0%) | ||
| Erectile dysfunction | 1/103 (1%) | 0/49 (0%) | ||
| Vaginal haemorrhage | 1/103 (1%) | 0/49 (0%) | ||
| Breast pain | 0/103 (0%) | 1/49 (2%) | ||
| Breast tenderness | 0/103 (0%) | 1/49 (2%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnoea | 20/103 (19.4%) | 9/49 (18.4%) | ||
| Cough | 12/103 (11.7%) | 6/49 (12.2%) | ||
| Rhinorrhoea | 9/103 (8.7%) | 0/49 (0%) | ||
| Epistaxis | 6/103 (5.8%) | 2/49 (4.1%) | ||
| Dysphonia | 5/103 (4.9%) | 1/49 (2%) | ||
| Oropharyngeal pain | 4/103 (3.9%) | 0/49 (0%) | ||
| Nasal congestion | 3/103 (2.9%) | 1/49 (2%) | ||
| Pleural effusion | 3/103 (2.9%) | 1/49 (2%) | ||
| Hypoxia | 4/103 (3.9%) | 0/49 (0%) | ||
| Productive cough | 3/103 (2.9%) | 1/49 (2%) | ||
| Respiratory failure | 3/103 (2.9%) | 0/49 (0%) | ||
| Haemoptysis | 2/103 (1.9%) | 2/49 (4.1%) | ||
| Dyspnoea exertional | 2/103 (1.9%) | 1/49 (2%) | ||
| Hiccups | 2/103 (1.9%) | 1/49 (2%) | ||
| Pneumonitis | 2/103 (1.9%) | 1/49 (2%) | ||
| Upper-airway cough syndrome | 2/103 (1.9%) | 1/49 (2%) | ||
| Acute respiratory failure | 2/103 (1.9%) | 0/49 (0%) | ||
| Nasal dryness | 2/103 (1.9%) | 0/49 (0%) | ||
| Chronic obstructive pulmonary disease | 1/103 (1%) | 1/49 (2%) | ||
| Pulmonary embolism | 1/103 (1%) | 1/49 (2%) | ||
| Rhinitis allergic | 1/103 (1%) | 1/49 (2%) | ||
| Obstructive airways disorder | 1/103 (1%) | 0/49 (0%) | ||
| Paranasal sinus hypersecretion | 1/103 (1%) | 0/49 (0%) | ||
| Pneumothorax | 1/103 (1%) | 0/49 (0%) | ||
| Sinus congestion | 1/103 (1%) | 0/49 (0%) | ||
| Wheezing | 1/103 (1%) | 0/49 (0%) | ||
| Catarrh | 1/103 (1%) | 0/49 (0%) | ||
| Increased bronchial secretion | 1/103 (1%) | 0/49 (0%) | ||
| Rhinalgia | 1/103 (1%) | 0/49 (0%) | ||
| Asthma | 0/103 (0%) | 1/49 (2%) | ||
| Bronchospasm | 0/103 (0%) | 1/49 (2%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 23/103 (22.3%) | 13/49 (26.5%) | ||
| Rash | 10/103 (9.7%) | 6/49 (12.2%) | ||
| Dry skin | 6/103 (5.8%) | 3/49 (6.1%) | ||
| Nail discolouration | 2/103 (1.9%) | 2/49 (4.1%) | ||
| Pruritus | 2/103 (1.9%) | 2/49 (4.1%) | ||
| Nail disorder | 3/103 (2.9%) | 3/49 (6.1%) | ||
| Rash maculo-papular | 2/103 (1.9%) | 2/49 (4.1%) | ||
| Erythema | 1/103 (1%) | 1/49 (2%) | ||
| Onycholysis | 1/103 (1%) | 1/49 (2%) | ||
| Onychomadesis | 1/103 (1%) | 1/49 (2%) | ||
| Rash papular | 1/103 (1%) | 1/49 (2%) | ||
| Dermatitis acneiform | 2/103 (1.9%) | 0/49 (0%) | ||
| Nail toxicity | 2/103 (1.9%) | 0/49 (0%) | ||
| Palmar-plantar erythrodysaesthesia syndrome | 2/103 (1.9%) | 0/49 (0%) | ||
| Nail dystrophy | 2/103 (1.9%) | 0/49 (0%) | ||
| Hyperkeratosis | 1/103 (1%) | 1/49 (2%) | ||
| Nail ridging | 1/103 (1%) | 1/49 (2%) | ||
| Skin exfoliation | 1/103 (1%) | 1/49 (2%) | ||
| Skin hyperpigmentation | 1/103 (1%) | 1/49 (2%) | ||
| Eczema | 1/103 (1%) | 0/49 (0%) | ||
| Erythema multiforme | 1/103 (1%) | 0/49 (0%) | ||
| Ingrowing nail | 1/103 (1%) | 0/49 (0%) | ||
| Plantar erythema | 1/103 (1%) | 0/49 (0%) | ||
| Psoriasis | 1/103 (1%) | 0/49 (0%) | ||
| Rash erythematous | 1/103 (1%) | 0/49 (0%) | ||
| Skin ulcer | 1/103 (1%) | 0/49 (0%) | ||
| Pain of skin | 2/103 (1.9%) | 0/49 (0%) | ||
| Hair colour changes | 1/103 (1%) | 0/49 (0%) | ||
| Hyperhidrosis | 0/103 (0%) | 2/49 (4.1%) | ||
| Dermatosis | 0/103 (0%) | 1/49 (2%) | ||
| Night sweats | 0/103 (0%) | 1/49 (2%) | ||
| Onychalgia | 0/103 (0%) | 1/49 (2%) | ||
| Surgical and medical procedures | ||||
| Pain management | 1/103 (1%) | 0/49 (0%) | ||
| Vascular disorders | ||||
| Hypotension | 7/103 (6.8%) | 2/49 (4.1%) | ||
| Orthostatic hypotension | 3/103 (2.9%) | 0/49 (0%) | ||
| Hypertension | 2/103 (1.9%) | 1/49 (2%) | ||
| Phlebitis | 2/103 (1.9%) | 0/49 (0%) | ||
| Deep vein thrombosis | 1/103 (1%) | 2/49 (4.1%) | ||
| Embolism | 1/103 (1%) | 0/49 (0%) | ||
| Haematoma | 1/103 (1%) | 0/49 (0%) | ||
| Haemorrhage | 1/103 (1%) | 0/49 (0%) | ||
| Hot flush | 1/103 (1%) | 0/49 (0%) | ||
| Ischaemia | 1/103 (1%) | 0/49 (0%) | ||
| Superior vena cava syndrome | 1/103 (1%) | 0/49 (0%) | ||
| Flushing | 1/103 (1%) | 0/49 (0%) | ||
| Hypertensive crisis | 0/103 (0%) | 1/49 (2%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | VP, Clinical Operations |
|---|---|
| Organization | Elevation oncology |
| Phone | +1-716 371 1125 |
| clinical@elevationoncology.com |
Responsible Party:
Elevation Oncology
ClinicalTrials.gov Identifier:
NCT02387216
Other Study ID Numbers:
- MM-121-01-02-09
First Posted:
Mar 12, 2015
Last Update Posted:
Oct 12, 2021
Last Verified:
Oct 1, 2021