Phase II Trial of Natalizumab + Prednisone for Initial Therapy of Acute GI GVHD
Study Details
Study Description
Brief Summary
This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug Natalizumab in treating Acute Graft-Versus-Host Disease (GVHD) in the Gastrointestinal (GI) Tract.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
Natalizumab is a drug that was initially discovered as a treatment for autoimmune conditions. Natalizumab has been approved for use in patients with Multiple Sclerosis and Crohn's disease. In these diseases, the drug works to inhibit dysfunctional immune cells that are responsible for the symptoms seen in these diseases. Acute graft versus host disease is caused by a similar dysfunction of immune cells; Natalizumab is thought to inhibit these immune cells, similarly to how it does in Multiple Sclerosis and Crohn's disease. In this research study,the investigators are looking to see whether Natalizumab provides additional benefit to patients receiving standard treatment for acute graft versus host disease of the gastrointestinal tract.
Participants who fulfill eligibility criteria will be entered into the trial to receive Natalizumab.
-
Participant will receive a dose of the natalizumab through intravenous infusion. Participants may receive a second dose at Day 28 if they experience a partial response or very good partial response.
-
Scheduled Physical Examination at screening, during the week of first dose and at 28 days, 56 days, 100 days, 180 days and one year.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Natalizumab Natalizumab- (Day 0 and 28) Fixed dose Intravenous infusion over one hour. 2 hours observation completion of the infusion At 4 weeks, if there has been less than a complete response participants can be treated with a second dose of natalizumab. If participants have no response after one dose, they will be not be given a second dose. Participants who receive a second dose of natalizumab will be evaluated for response at day 56 after first treatment dose administered. Participants will be assessed for response to therapy with natalizumab at day +28, day +56, day +100, day + 180, and day +365. Commercial supplies of Methylprednisolone (or equivalent steroid) will be utilized. The formulation, preparation and route of administration will be as per package insert |
Drug: Natalizumab
Other Names:
Drug: Methylprednisolone
Other Names:
|
Outcome Measures
Primary Outcome Measures
- GVHD-free Survival Rate [Day 56]
Graft-versus-host disease (GVHD) free survival is defined as achieving complete response without death or relapse or requiring secondary immunosuppressive therapy . Proportions are reported descriptively. GVHD-free survival was assessed using the Kaplan-Meier method.
Secondary Outcome Measures
- Graft-verus-host Disease (GVHD) Response Rate [28 Days, 56 Days]
Complete Response (CR) is defined as resolution of all signs and symptoms of acute GVHD. Very Good Partial Response (VGPR) is defined by no rash or residual erythematous rash involving less than 25% of the body surface, and total serum bilirubin concentration less than 2 mg/dL or less than 25% of baseline at enrollment and tolerating food or enteral feeding, predominantly formed stools, no overt gastrointestinal bleeding or abdominal cramping, and no more than occasional nausea and vomiting. Partial Response (PR) is defined as an improvement of one stage in one or more organs without progression in any other organ. Non-response (NR) is defined as no reduction in any GVHD organ staging. Progression is defined as either new organ involvement on day +8 or thereafter, or increased organ specific symptoms sufficient to increase the organ stage by one or more or the initiation of an additional GVHD agent. Overall Response Rate (ORR) is the sum of CR, VGPR, and PR.
- GI aGVHD Response Rate [Day 28, Day 56]
Gastrointestinal (GI) acute graft-versus-host disease (GVHD) Response is defined by complete response, very good partial response, or partial response in signs and symptoms of GI aGVHD.
- Overall Survival (OS) Rate [2 years]
Overall survival (OS) is defined from the date of natalizumab infusion to death or censored at last clinical evaluation. OS was estimated using the Kaplan-Meier method.
- Rate of GVHD Flares [by Day 28]
Number of subjects who experienced graft-versus-host disease (GVHD) flares requiring therapy after initial complete response (CR) or partial response (PR) by day 28 after the first dose of Natalizumab.
- Percentage Steroid Dose Was Reduced at Day 28, 56, and 100 in Comparison to Steroid Dose at First Administration of Natalizumab. [Day 28, 56, and 100]
Median percentage steroid dose was reduced at Day 28, Day 56, and Day 100 in comparison to steroid dose at first administration of Natalizumab.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participants must meet the following criteria on screening examination to be eligible to participate in the study:
-
Participants must have acute Graft-Versus-Host Disease (GVHD) of the lower gastrointestinal tract as defined by the clinical impression of the treating physician, requiring systemic treatment. Minimum criteria for GI GVHD includes diarrhea of greater than 500 mL/day. Biopsy of the GI tract is required for study entry and must confirm the diagnosis of acute GVHD. Stool samples to rule out infectious causes of diarrhea, including norovirus, Clostridium difficile and other clinically indicated infections must also be negative. Eligibility includes:
-
Acute GVHD developing after allogeneic hematopoietic stem cell transplantation (HSCT) using bone marrow, peripheral blood stem cells, or umbilical cord blood. Recipients of non-myeloablative, reduced intensity and myeloablative transplants are eligible.
-
Patients who develop acute GVHD after donor lymphocyte infusion (DLI) are eligible.
-
There is no specified time window after day 0 of transplant as acute GVHD is only defined by clinical manifestations.
-
Patients must have experienced neutrophil engraftment after HSCT as defined by absolute neutrophil counts ≥ 500 / µL × 3 consecutive measurements. Absolute neutrophil count (ANC) should be calculated using the standard formula (Neut + Bands)(WBC × 101).
-
The presence of hepatic, upper GI and/or cutaneous acute GVHD is permitted.
-
Steroids can be started up to 7 days prior to the administration of natalizumab.
-
Age ≥ 18
-
Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
-
Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study:
-
Patients with the entity of Acute/Chronic GVHD overlap syndromes.
-
Requiring mechanical ventilation
-
Vasopressor requirement
-
Concurrent hepatic veno-occlusive disease (VOD) based on clinical examination
-
Karnofsky performance status < 30
-
Participants may not be receiving any other study agents for at least 7 days prior to enrollment
-
Prior use of natalizumab for any reason is not allowed
-
Pregnant women are excluded from this study because of the potential teratogenic effects of natalizumab. Because natalizumab enters breast milk, and the effect is unknown in infants, breastfeeding should be discontinued if the mother is treated with natalizumab.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 2 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
Sponsors and Collaborators
- Dana-Farber Cancer Institute
- Biogen
Investigators
- Principal Investigator: Corey Cutler, MD, MPH, Dana-Farber Cancer Institute
Study Documents (Full-Text)
More Information
Publications
None provided.- 14-140
Study Results
Participant Flow
| Recruitment Details | This study enrolled subjects with newly diagnosed acute gastrointestinal (GI) graft-versus-host-disease (GVHD) from 2 academic medical centers in the United States. The last patient completed the study in February 2019. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Natalizumab |
|---|---|
| Arm/Group Description | Natalizumab- (Day 0 and 28) Fixed dose Intravenous infusion over one hour. 2 hours observation completion of the infusion At 4 weeks, if there has been less than a complete response participants can be treated with a second dose of natalizumab. If participants have no response after one dose, they will be not be given a second dose. Participants who receive a second dose of natalizumab will be evaluated for response at day 56 after first treatment dose administered. Participants will be assessed for response to therapy with natalizumab at day +28, day +56, day +100, day + 180, and day +365. Commercial supplies of Methylprednisolone (or equivalent steroid) will be utilized. The formulation, preparation and route of administration will be as per package insert |
| Period Title: Overall Study | |
| STARTED | 21 |
| COMPLETED | 9 |
| NOT COMPLETED | 12 |
Baseline Characteristics
| Arm/Group Title | Natalizumab |
|---|---|
| Arm/Group Description | Natalizumab- (Day 0 and 28) Fixed dose Intravenous infusion over one hour. 2 hours observation completion of the infusion At 4 weeks, if there has been less than a complete response participants can be treated with a second dose of natalizumab. If participants have no response after one dose, they will be not be given a second dose. Participants who receive a second dose of natalizumab will be evaluated for response at day 56 after first treatment dose administered. Participants will be assessed for response to therapy with natalizumab at day +28, day +56, day +100, day + 180, and day +365. Commercial supplies of Methylprednisolone (or equivalent steroid) will be utilized. The formulation, preparation and route of administration will be as per package insert |
| Overall Participants | 21 |
| Age (Years) [Median (Full Range) ] | |
| Median (Full Range) [Years] |
63
|
| Sex: Female, Male (Count of Participants) | |
| Female |
6
28.6%
|
| Male |
15
71.4%
|
| Race and Ethnicity Not Collected (Count of Participants) | |
| Region of Enrollment (Count of Participants) | |
| United States |
21
100%
|
| Acute GVHD Staging (Adapted from Glucksberg, H. et al. Transplantation 1974; 18:295) (Count of Participants) | |
| Gastrointestinal Stage 1 |
4
19%
|
| Gastrointestinal Stage 2 |
5
23.8%
|
| Gastrointestinal Stage 3 |
4
19%
|
| Gastrointestinal Stage 4 |
8
38.1%
|
| No liver involvement |
20
95.2%
|
| Liver Stage 2 |
1
4.8%
|
| No skin involvement |
17
81%
|
| Skin Stage 2 |
4
19%
|
| Disease Status of Underlying Malignancy at time of Hematopoietic Stem Cell Transplantation (HSCT) (Count of Participants) | |
| First Complete Remission |
9
42.9%
|
| Second Complete Remission |
5
23.8%
|
| Relapsed Disease |
2
9.5%
|
| Progressive Disease |
2
9.5%
|
| Treatment Failure |
3
14.3%
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status at HSCT (Count of Participants) | |
| 00 - Fully Active |
2
9.5%
|
| 01 - Restricted |
9
42.9%
|
| 02 - Self Care |
7
33.3%
|
| 03 - Capable of Limited Self Care |
3
14.3%
|
| Conditioning Regimen (Count of Participants) | |
| Myeloablative |
3
14.3%
|
| Non-myeloablative |
18
85.7%
|
| Donor type (Count of Participants) | |
| Matched Unrelated |
15
71.4%
|
| Matched Related |
5
23.8%
|
| Mismatch Unrelated |
1
4.8%
|
| Donor source (Count of Participants) | |
| Bone marrow and Peripheral Blood Stem Cells |
1
4.8%
|
| Peripheral Blood Stem Cells |
20
95.2%
|
| Acute GVHD Grading (Adapted from Glucksberg, H. et al. Transplantation 1974; 18:295) (Count of Participants) | |
| Overall Grade II |
9
42.9%
|
| Overall Grade III |
12
57.1%
|
Outcome Measures
| Title | GVHD-free Survival Rate |
|---|---|
| Description | Graft-versus-host disease (GVHD) free survival is defined as achieving complete response without death or relapse or requiring secondary immunosuppressive therapy . Proportions are reported descriptively. GVHD-free survival was assessed using the Kaplan-Meier method. |
| Time Frame | Day 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Natalizumab |
|---|---|
| Arm/Group Description | Natalizumab- (Day 0 and 28) Fixed dose Intravenous infusion over one hour. 2 hours observation completion of the infusion At 4 weeks, if there has been less than a complete response participants can be treated with a second dose of natalizumab. If participants have no response after one dose, they will be not be given a second dose. Participants who receive a second dose of natalizumab will be evaluated for response at day 56 after first treatment dose administered. Participants will be assessed for response to therapy with natalizumab at day +28, day +56, day +100, day + 180, and day +365. Commercial supplies of Methylprednisolone (or equivalent steroid) will be utilized. The formulation, preparation and route of administration will be as per package insert. |
| Measure Participants | 21 |
| Number [percentage of patients] |
33.3
|
| Title | Graft-verus-host Disease (GVHD) Response Rate |
|---|---|
| Description | Complete Response (CR) is defined as resolution of all signs and symptoms of acute GVHD. Very Good Partial Response (VGPR) is defined by no rash or residual erythematous rash involving less than 25% of the body surface, and total serum bilirubin concentration less than 2 mg/dL or less than 25% of baseline at enrollment and tolerating food or enteral feeding, predominantly formed stools, no overt gastrointestinal bleeding or abdominal cramping, and no more than occasional nausea and vomiting. Partial Response (PR) is defined as an improvement of one stage in one or more organs without progression in any other organ. Non-response (NR) is defined as no reduction in any GVHD organ staging. Progression is defined as either new organ involvement on day +8 or thereafter, or increased organ specific symptoms sufficient to increase the organ stage by one or more or the initiation of an additional GVHD agent. Overall Response Rate (ORR) is the sum of CR, VGPR, and PR. |
| Time Frame | 28 Days, 56 Days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Natalizumab |
|---|---|
| Arm/Group Description | Natalizumab- (Day 0 and 28) Fixed dose Intravenous infusion over one hour. 2 hours observation completion of the infusion At 4 weeks, if there has been less than a complete response participants can be treated with a second dose of natalizumab. If participants have no response after one dose, they will be not be given a second dose. Participants who receive a second dose of natalizumab will be evaluated for response at day 56 after first treatment dose administered. Participants will be assessed for response to therapy with natalizumab at day +28, day +56, day +100, day + 180, and day +365. Commercial supplies of Methylprednisolone (or equivalent steroid) will be utilized. The formulation, preparation and route of administration will be as per package insert. |
| Measure Participants | 21 |
| Overall Response at Day 28 |
12
57.1%
|
| Complete Response at Day 28 |
7
33.3%
|
| Very Good Partial Response at Day 28 |
2
9.5%
|
| Partial Response at Day 28 |
3
14.3%
|
| Non-response/Progression of GVHD at Day 28 |
7
33.3%
|
| Overall Response at Day 56 |
11
52.4%
|
| Complete Response at Day 56 |
7
33.3%
|
| Very Good Partial Response at Day 56 |
2
9.5%
|
| Partial Response at Day 56 |
2
9.5%
|
| Non-response/Progression of GVHD at Day 56 |
6
28.6%
|
| Title | GI aGVHD Response Rate |
|---|---|
| Description | Gastrointestinal (GI) acute graft-versus-host disease (GVHD) Response is defined by complete response, very good partial response, or partial response in signs and symptoms of GI aGVHD. |
| Time Frame | Day 28, Day 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Natalizumab |
|---|---|
| Arm/Group Description | Natalizumab- (Day 0 and 28) Fixed dose Intravenous infusion over one hour. 2 hours observation completion of the infusion At 4 weeks, if there has been less than a complete response participants can be treated with a second dose of natalizumab. If participants have no response after one dose, they will be not be given a second dose. Participants who receive a second dose of natalizumab will be evaluated for response at day 56 after first treatment dose administered. Participants will be assessed for response to therapy with natalizumab at day +28, day +56, day +100, day + 180, and day +365. Commercial supplies of Methylprednisolone (or equivalent steroid) will be utilized. The formulation, preparation and route of administration will be as per package insert. |
| Measure Participants | 21 |
| Overall response rate for GI GVHD at Day 28 |
57
|
| Overall response rate for GI GVHD at Day 56 |
52
|
| Title | Overall Survival (OS) Rate |
|---|---|
| Description | Overall survival (OS) is defined from the date of natalizumab infusion to death or censored at last clinical evaluation. OS was estimated using the Kaplan-Meier method. |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Natalizumab |
|---|---|
| Arm/Group Description | Natalizumab- (Day 0 and 28) Fixed dose Intravenous infusion over one hour. 2 hours observation completion of the infusion At 4 weeks, if there has been less than a complete response participants can be treated with a second dose of natalizumab. If participants have no response after one dose, they will be not be given a second dose. Participants who receive a second dose of natalizumab will be evaluated for response at day 56 after first treatment dose administered. Participants will be assessed for response to therapy with natalizumab at day +28, day +56, day +100, day + 180, and day +365. Commercial supplies of Methylprednisolone (or equivalent steroid) will be utilized. The formulation, preparation and route of administration will be as per package insert. |
| Measure Participants | 21 |
| Number [percentage of patients] |
43
|
| Title | Rate of GVHD Flares |
|---|---|
| Description | Number of subjects who experienced graft-versus-host disease (GVHD) flares requiring therapy after initial complete response (CR) or partial response (PR) by day 28 after the first dose of Natalizumab. |
| Time Frame | by Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Natalizumab |
|---|---|
| Arm/Group Description | Natalizumab- (Day 0 and 28) Fixed dose Intravenous infusion over one hour. 2 hours observation completion of the infusion At 4 weeks, if there has been less than a complete response participants can be treated with a second dose of natalizumab. If participants have no response after one dose, they will be not be given a second dose. Participants who receive a second dose of natalizumab will be evaluated for response at day 56 after first treatment dose administered. Participants will be assessed for response to therapy with natalizumab at day +28, day +56, day +100, day + 180, and day +365. Commercial supplies of Methylprednisolone (or equivalent steroid) will be utilized. The formulation, preparation and route of administration will be as per package insert Natalizumab Methylprednisolone |
| Measure Participants | 21 |
| Count of Participants [Participants] |
0
0%
|
| Title | Percentage Steroid Dose Was Reduced at Day 28, 56, and 100 in Comparison to Steroid Dose at First Administration of Natalizumab. |
|---|---|
| Description | Median percentage steroid dose was reduced at Day 28, Day 56, and Day 100 in comparison to steroid dose at first administration of Natalizumab. |
| Time Frame | Day 28, 56, and 100 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Natalizumab |
|---|---|
| Arm/Group Description | Natalizumab- (Day 0 and 28) Fixed dose Intravenous infusion over one hour. 2 hours observation completion of the infusion At 4 weeks, if there has been less than a complete response participants can be treated with a second dose of natalizumab. If participants have no response after one dose, they will be not be given a second dose. Participants who receive a second dose of natalizumab will be evaluated for response at day 56 after first treatment dose administered. Participants will be assessed for response to therapy with natalizumab at day +28, day +56, day +100, day + 180, and day +365. Commercial supplies of Methylprednisolone (or equivalent steroid) will be utilized. The formulation, preparation and route of administration will be as per package insert. |
| Measure Participants | 21 |
| Median reduction in steroid dose at day 28 |
42
|
| Median reduction in steroid dose at day 56 |
71
|
| Median reduction in steroid dose at day 100 |
85
|
Adverse Events
| Time Frame | 1 year | |
|---|---|---|
| Adverse Event Reporting Description | All grade 2 related and unexpected and all grade 3 and higher adverse events experienced by participants were collected from the time of the first dose of study treatment, through the study and until the final study visit. Grade 4 skin rash, diarrhea and increased bilirubin were expected adverse events as a result of acute graft-versus-host disease (aGVHD) and did not require reporting. All positive John Cunningham (JC) viral loads required reporting regardless of grade. | |
| Arm/Group Title | Natalizumab | |
| Arm/Group Description | Natalizumab- (Day 0 and 28) Fixed dose Intravenous infusion over one hour. 2 hours observation completion of the infusion At 4 weeks, if there has been less than a complete response participants can be treated with a second dose of natalizumab. If participants have no response after one dose, they will be not be given a second dose. Participants who receive a second dose of natalizumab will be evaluated for response at day 56 after first treatment dose administered. Participants will be assessed for response to therapy with natalizumab at day +28, day +56, day +100, day + 180, and day +365. Commercial supplies of Methylprednisolone (or equivalent steroid) will be utilized. The formulation, preparation and route of administration will be as per package insert. | |
All Cause Mortality |
||
| Natalizumab | ||
| Affected / at Risk (%) | # Events | |
| Total | 12/21 (57.1%) | |
Serious Adverse Events |
||
| Natalizumab | ||
| Affected / at Risk (%) | # Events | |
| Total | 8/21 (38.1%) | |
| Blood and lymphatic system disorders | ||
| Thrombocytopenia | 1/21 (4.8%) | 1 |
| Thrombotic microangiopathy | 1/21 (4.8%) | 1 |
| Cardiac disorders | ||
| Hypotension | 1/21 (4.8%) | 1 |
| Paroxysmal atrial tachycardia | 1/21 (4.8%) | 1 |
| Hepatobiliary disorders | ||
| Hepatic failure | 1/21 (4.8%) | 1 |
| Infections and infestations | ||
| Stenotrophomonas bacteremia | 1/21 (4.8%) | 1 |
| Klebsiella infection | 1/21 (4.8%) | 1 |
| Sepsis | 2/21 (9.5%) | 2 |
| CMV viremia | 1/21 (4.8%) | 1 |
| C. diff colitis | 1/21 (4.8%) | 1 |
| Nervous system disorders | ||
| Subarachnoid hemorrhage | 1/21 (4.8%) | 1 |
| Intraparenchymal hemorrhage | 1/21 (4.8%) | 1 |
| Renal and urinary disorders | ||
| Acute kidney injury | 2/21 (9.5%) | 2 |
| Respiratory, thoracic and mediastinal disorders | ||
| Hypoxia | 1/21 (4.8%) | 1 |
| Adult respiratory distress syndrome | 2/21 (9.5%) | 2 |
| Bronchopneumonia | 1/21 (4.8%) | 1 |
| Diffuse alveolar hemorrhage | 1/21 (4.8%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Natalizumab | ||
| Affected / at Risk (%) | # Events | |
| Total | 19/21 (90.5%) | |
| Blood and lymphatic system disorders | ||
| Anemia | 2/21 (9.5%) | 2 |
| Blood and lymphatic system disorders - other | 4/21 (19%) | 4 |
| Thrombotic thrombocytopenic purpura | 1/21 (4.8%) | 1 |
| Eye disorders | ||
| Blurred vision | 1/21 (4.8%) | 1 |
| Gastrointestinal disorders | ||
| Abdominal pain | 3/21 (14.3%) | 3 |
| Cecal infection | 1/21 (4.8%) | 1 |
| Colitis | 1/21 (4.8%) | 1 |
| Diarrhea | 6/21 (28.6%) | 6 |
| Duodenal ulcer | 1/21 (4.8%) | 1 |
| Dyspepsia | 1/21 (4.8%) | 1 |
| Gastrointestinal disorders - other | 4/21 (19%) | 4 |
| Gastroparesis | 1/21 (4.8%) | 1 |
| Nausea | 1/21 (4.8%) | 1 |
| General disorders | ||
| Edema limbs | 2/21 (9.5%) | 2 |
| Localized edema | 1/21 (4.8%) | 1 |
| Multi-organ failure | 2/21 (9.5%) | 2 |
| Hepatobiliary disorders | ||
| Hepatobiliary disorders - other | 1/21 (4.8%) | 1 |
| Portal hypertension | 1/21 (4.8%) | 1 |
| Infections and infestations | ||
| Enterocolitis infectious | 3/21 (14.3%) | 3 |
| Infections and infestations - other | 2/21 (9.5%) | 2 |
| Small intestine infection | 2/21 (9.5%) | 2 |
| Urinary tract infection | 1/21 (4.8%) | 1 |
| Investigations | ||
| Weight loss | 2/21 (9.5%) | 2 |
| Alanine aminotransferase increased | 1/21 (4.8%) | 1 |
| Aspartate aminotransferase increased | 1/21 (4.8%) | 1 |
| Blood bilirubin increased | 2/21 (9.5%) | 2 |
| Investigations - other | 1/21 (4.8%) | 1 |
| Platelet count decreased | 3/21 (14.3%) | 3 |
| Metabolism and nutrition disorders | ||
| Hyperglycemia | 6/21 (28.6%) | 6 |
| Hypertriglyceridemia | 1/21 (4.8%) | 1 |
| Hypokalemia | 1/21 (4.8%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 1/21 (4.8%) | 1 |
| Musculoskeletal and connective tissue disorder - other | 1/21 (4.8%) | 1 |
| Myositis | 1/21 (4.8%) | 1 |
| Pain in extremity | 1/21 (4.8%) | 1 |
| Trismus | 1/21 (4.8%) | 1 |
| Nervous system disorders | ||
| Encephalopathy | 1/21 (4.8%) | 1 |
| Headache | 1/21 (4.8%) | 1 |
| Nervous system disorders - other | 1/21 (4.8%) | 1 |
| Renal and urinary disorders | ||
| Acute kidney injury | 2/21 (9.5%) | 2 |
| Hoarseness | 1/21 (4.8%) | 1 |
| Reproductive system and breast disorders | ||
| Genital edema | 1/21 (4.8%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Respiratory failure | 1/21 (4.8%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Dry skin | 1/21 (4.8%) | 1 |
| Vascular disorders | ||
| Hypertension | 2/21 (9.5%) | 2 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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 | Dr. Corey Cutler |
|---|---|
| Organization | Dana-Farber Cancer Institute |
| Phone | 617-632-3470 |
| CSCUTLER@PARTNERS.ORG |
- 14-140