Bortezomib and Vorinostat in Treating Patients With Recurrent Mantle Cell Lymphoma or Recurrent and/or Refractory Diffuse Large B-Cell Lymphoma
Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00703664
Collaborator
(none)
65
12
1
112.8
5.4
0
Study Details
Study Description
Brief Summary
This phase II trial studies how well bortezomib and vorinostat work in treating patients with recurrent mantle cell lymphoma or recurrent and/or refractory diffuse large B-cell lymphoma. Bortezomib and vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This was a multicenter, non-randomized phase 2 trial using a Simon two-stage design with 3 cohorts.
PRIMARY OBJECTIVES:
- Estimate the response rates of mantle cell and diffuse large B-cell lymphomas to bortezomib and vorinostat combination therapy.
SECONDARY OBJECTIVES:
- Assess the safety and tolerability of the study regimen. II. Observe progression-free survival and response durations. III. Observe the relationship between pretreatment lymphoma cell nuclear v-rel reticuloendotheliosis viral oncogene homolog A (relA) and response.
OUTLINE:
Patients receive vorinostat orally (PO) once daily (QD) on days 1-5 and 8-12. Patients also receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Study Design
Study Type:
Interventional
Actual Enrollment
:
65 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Trial of Bortezomib and Vorinostat in Mantle Cell and Diffuse Large B-Cell Lymphomas
Actual Study Start Date
:
Jul 9, 2008
Actual Primary Completion Date
:
Dec 1, 2017
Actual Study Completion Date
:
Dec 1, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment (vorinostat, bortezomib) Participants receive vorinostat orally (PO) once daily (QD) on days 1-5 and 8-12. Participants also receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Vorinostat precedes bortezomib on days of concurrent administration. Courses repeat every 3 weeks in the absence of disease progression - or unacceptable toxicity. After completion of study therapy, participants are followed periodically. Treatment arm consists of 3 cohorts, all receiving the same treatment: A: Mantle Cell Lymphoma (MCL) - with no prior bortezomib. B: Mantle Cell Lymphoma (MCL) - with no prior bortezomib. C: Diffuse Large B-Cell Lymphoma (DLBCL) - with no prior bortezomib. |
Drug: Bortezomib
Bortezomib: 1.3 mg/m^2/d IV days 1, 4, 8, and 11.
Other Names:
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Vorinostat
Vorinostat: 400 mg (total daily dose as a single dose) days 1-5 and 8-12.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Response Rate (ORR) [Up to 9 years]
ORR: Complete Response (CR) + Partial Response (PR) assessed according to the Revised Response Criteria for Malignant Lymphoma.
Secondary Outcome Measures
- Best Response [Up to 9 years]
Number of participants per category: Partial Response (PR), Stable Disease (SD), Progressive Disease (PD). PR: Regression of measurable disease and no new sites. SD: Failure to attain Complete Response (CR), /PR or PD. Relapsed or Progressive Disease: Any new lesion or increase by ≥ 50% of previously involved sites from nadir.
- Progression-free Survival (PFS) [Up to 9 years]
Median progression-free survival in months per cohort.
- Duration of Partial Response [Up to 9 years]
Median duration of response per cohort.
- Duration of Stable Disease [Up to 9 years]
Median duration of stable disease per cohort.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Histologically confirmed mantle cell or diffuse large B-cell lymphoma; histological material must be available for central pathological review; unstained histological material -- slides or blocks -- must be available for correlative studies; archived material from previous biopsies is acceptable, unless a patient's lymphoma has been known to undergo histological transformation in the past, in which case a repeat biopsy to confirm histology prior to enrollment is required; availability of material must be confirmed at the time of registration, but material may be submitted subsequent to registration and initiation of study treatment
-
Measurable disease according to the Revised Response Criteria for Malignant Lymphoma; this requires at least one lesion greater than 1.0 cm in diameter in both the long and short axis as measured by spiral computed tomography (CT) scan or physical exam
-
Prior allogeneic stem cell transplant is allowed provided that all of the following conditions are met:
-
= 6 months have elapsed since allogeneic transplant
-
No graft vs. host disease (GVHD) is present
-
Not currently on immunosuppressive therapy
-
Prior therapy:
-
Mantle cell lymphoma:
-
Previously treated or untreated
-
No prior bortezomib
-
Diffuse large B-cell lymphoma:
-
At least one prior systemic therapy
-
No prior bortezomib
-
Note: Not intended for patients in first relapse who are candidates for high dose therapy with stem cell support
-
Life expectancy of greater than 3 months
-
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
-
Able to tolerate loperamide or other anti-diarrheal medications
-
Absolute neutrophil count >= 1.5 x 10^9/L
-
Platelets >= 75 x 10^9/L
-
Total bilirubin =< 1.5 x upper limit of normal (ULN)
-
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transferase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
-
Creatinine within normal institutional limits or calculated creatinine clearance >= 60 mL/min according to the Cockcroft-Gault formula
-
For patients with known human immunodeficiency virus (HIV) infection, a cluster of differentiation (CD)4 count >= 0.5 x 10^9/L
-
For patients whose last treatment included bendamustine or fludarabine, a CD4 count >= 0.4 x 10^9/L
-
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and to report pregnancy or suspected pregnancy while participating in the study
-
Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
-
Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study
-
Prior histone deacetylase inhibitor as cancer treatment
-
Concurrent treatment with other investigational agents
-
Plans for other concurrent cancer treatment; if steroids for cancer control have been used, patients must be off these agents for >= 1 week before starting treatment; exception: maintenance therapy for non-malignant disease with prednisone or steroid equivalent dose < 10 mg/day is permitted
-
History of brain metastasis including leptomeningeal metastasis
-
Grade >= 2 neuropathy, regardless of cause
-
Unable to take oral medications
-
History of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib or vorinostat
-
Not sufficiently recovered from previous treatment
-
Medical or other condition (for example: uncontrolled infection; potentially life threatening changes on electrocardiogram [EKG]) or concurrent treatment (for example, marrow suppressive agents such as zidovudine) that represents an inappropriate risk to the patient or likely would compromise achievement of the primary study objective; patients should be closely monitored when given bortezomib in combination with the cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors and inducers
-
Pregnant women are excluded from this study; breastfeeding should be discontinued
-
Active concurrent malignancy, except adequately treated non-melanoma skin cancer
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Moffitt Cancer Center | Tampa | Florida | United States | 33612 |
| 2 | Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | United States | 30322 |
| 3 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 4 | University of Chicago Comprehensive Cancer Center | Chicago | Illinois | United States | 60637 |
| 5 | University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | United States | 21201 |
| 6 | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | United States | 08903 |
| 7 | Montefiore Medical Center-Weiler Hospital | Bronx | New York | United States | 10461 |
| 8 | Montefiore Medical Center - Moses Campus | Bronx | New York | United States | 10467 |
| 9 | Weill Medical College of Cornell University | New York | New York | United States | 10065 |
| 10 | UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | United States | 27599 |
| 11 | Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | United States | 37232 |
| 12 | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | United States | 23298 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Beata Holkova, Massey Cancer Center
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00703664
Other Study ID Numbers:
- NCI-2009-00275
- NCI-2009-00275
- CDR0000598308
- MCC-15428
- 8064
- N01CM00071
- N01CM00100
- N01CM62201
- N01CM62204
- N01CM62208
- P30CA076292
First Posted:
Jun 23, 2008
Last Update Posted:
Aug 7, 2018
Last Verified:
Jul 1, 2018
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were enrolled at 12 participating cancer center sites in the United States, from July 2008 through December 2013. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Treatment: Cohort A - MCL; No Prior Bortezomib | Treatment: Cohort B - MCL; Prior Bortezomib | Treatment: Cohort C - DLBCL; No Prior Bortezomib |
|---|---|---|---|
| Arm/Group Description | Mantle Cell Lymphoma (MCL): Treatment (vorinostat, bortezomib). Participants receive vorinostat orally (PO) once daily (QD) on days 1-5 and 8-12. Participants also receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Vorinostat precedes bortezomib on days of concurrent administration. Courses repeat every 3 weeks in the absence of disease progression - or unacceptable toxicity. After completion of study therapy, participants are followed periodically. | Mantle Cell Lymphoma MCL: Treatment (vorinostat, bortezomib). Participants receive vorinostat orally (PO) once daily (QD) on days 1-5 and 8-12. Participants also receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Vorinostat precedes bortezomib on days of concurrent administration. Courses repeat every 3 weeks in the absence of disease progression - or unacceptable toxicity. After completion of study therapy, participants are followed periodically. | Diffuse Large B-Cell Lymphoma (DLBCL): Treatment (vorinostat, bortezomib). Participants receive vorinostat orally (PO) once daily (QD) on days 1-5 and 8-12. Participants also receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Vorinostat precedes bortezomib on days of concurrent administration. Courses repeat every 3 weeks in the absence of disease progression - or unacceptable toxicity. After completion of study therapy, participants are followed periodically. |
| Period Title: Overall Study | |||
| STARTED | 22 | 4 | 39 |
| COMPLETED | 22 | 4 | 39 |
| NOT COMPLETED | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Treatment: Cohort A - MCL; No Prior Bortezomib | Treatment: Cohort B - MCL; Prior Bortezomib | Treatment: Cohort C - DLBCL; No Prior Bortezomib | Total |
|---|---|---|---|---|
| Arm/Group Description | Mantle Cell Lymphoma (MCL): Treatment (vorinostat, bortezomib). Participants receive vorinostat orally (PO) once daily (QD) on days 1-5 and 8-12. Participants also receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Vorinostat precedes bortezomib on days of concurrent administration. Courses repeat every 3 weeks in the absence of disease progression - or unacceptable toxicity. After completion of study therapy, participants are followed periodically. | Mantle Cell Lymphoma MCL: Treatment (vorinostat, bortezomib). Participants receive vorinostat orally (PO) once daily (QD) on days 1-5 and 8-12. Participants also receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Vorinostat precedes bortezomib on days of concurrent administration. Courses repeat every 3 weeks in the absence of disease progression - or unacceptable toxicity. After completion of study therapy, participants are followed periodically. | Diffuse Large B-Cell Lymphoma (DLBCL): Treatment (vorinostat, bortezomib). Participants receive vorinostat orally (PO) once daily (QD) on days 1-5 and 8-12. Participants also receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Vorinostat precedes bortezomib on days of concurrent administration. Courses repeat every 3 weeks in the absence of disease progression - or unacceptable toxicity. After completion of study therapy, participants are followed periodically. | Total of all reporting groups |
| Overall Participants | 22 | 4 | 39 | 65 |
| Age (years) [Median (Full Range) ] | ||||
| Median (Full Range) [years] |
64
|
63
|
57
|
60
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
5
22.7%
|
0
0%
|
13
33.3%
|
18
27.7%
|
| Male |
17
77.3%
|
4
100%
|
26
66.7%
|
47
72.3%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
2
9.1%
|
0
0%
|
5
12.8%
|
7
10.8%
|
| White |
19
86.4%
|
4
100%
|
30
76.9%
|
53
81.5%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
4.5%
|
0
0%
|
4
10.3%
|
5
7.7%
|
| Region of Enrollment (Count of Participants) | ||||
| United States |
22
100%
|
4
100%
|
39
100%
|
65
100%
|
| Eastern Cooperative Oncology Group (ECOG) Status (Count of Participants) | ||||
| Status: 0 |
13
59.1%
|
3
75%
|
11
28.2%
|
27
41.5%
|
| Status: 1 |
9
40.9%
|
1
25%
|
19
48.7%
|
29
44.6%
|
| Status: 2 |
0
0%
|
0
0%
|
9
23.1%
|
9
13.8%
|
Outcome Measures
| Title | Overall Response Rate (ORR) |
|---|---|
| Description | ORR: Complete Response (CR) + Partial Response (PR) assessed according to the Revised Response Criteria for Malignant Lymphoma. |
| Time Frame | Up to 9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants. |
| Arm/Group Title | Cohort A - MCL | Cohort B - MCL | Cohort C - DLBCL |
|---|---|---|---|
| Arm/Group Description | Mantle Cell Lymphoma (MCL): Treatment (vorinostat, bortezomib). | Mantle Cell Lymphoma MCL: Treatment (vorinostat, bortezomib). | Diffuse Large B-Cell Lymphoma (DLBCL): Treatment (vorinostat, bortezomib). |
| Measure Participants | 22 | 4 | 39 |
| Number [percentage of participants] |
31.8
144.5%
|
0
0%
|
7.7
19.7%
|
| Title | Best Response |
|---|---|
| Description | Number of participants per category: Partial Response (PR), Stable Disease (SD), Progressive Disease (PD). PR: Regression of measurable disease and no new sites. SD: Failure to attain Complete Response (CR), /PR or PD. Relapsed or Progressive Disease: Any new lesion or increase by ≥ 50% of previously involved sites from nadir. |
| Time Frame | Up to 9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants evaluable and available at time of assessment. |
| Arm/Group Title | Cohort A - MCL | Cohort B - MCL | Cohort C - DLBCL |
|---|---|---|---|
| Arm/Group Description | Mantle Cell Lymphoma (MCL): Treatment (vorinostat, bortezomib). | Mantle Cell Lymphoma MCL: Treatment (vorinostat, bortezomib). | Diffuse Large B-Cell Lymphoma (DLBCL): Treatment (vorinostat, bortezomib). |
| Measure Participants | 19 | 4 | 34 |
| Partial Response |
7
31.8%
|
0
0%
|
3
7.7%
|
| Stable Disease |
5
22.7%
|
2
50%
|
8
20.5%
|
| Progressive Disease |
7
31.8%
|
2
50%
|
23
59%
|
| Title | Progression-free Survival (PFS) |
|---|---|
| Description | Median progression-free survival in months per cohort. |
| Time Frame | Up to 9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| All evaluable participants at time of analysis. Cohort B was closed early due to lack of accrual. |
| Arm/Group Title | Cohort A - MCL | Cohort B - MCL | Cohort C - DLBCL |
|---|---|---|---|
| Arm/Group Description | Mantle Cell Lymphoma (MCL): Treatment (vorinostat, bortezomib). | Mantle Cell Lymphoma MCL: Treatment (vorinostat, bortezomib). | Diffuse Large B-Cell Lymphoma (DLBCL): Treatment (vorinostat, bortezomib). |
| Measure Participants | 22 | 0 | 39 |
| Median (95% Confidence Interval) [months] |
7.6
|
1.8
|
| Title | Duration of Partial Response |
|---|---|
| Description | Median duration of response per cohort. |
| Time Frame | Up to 9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants with Partial Response. |
| Arm/Group Title | Cohort A - MCL | Cohort B - MCL | Cohort C - DLBCL |
|---|---|---|---|
| Arm/Group Description | Mantle Cell Lymphoma (MCL): Treatment (vorinostat, bortezomib). | Mantle Cell Lymphoma MCL: Treatment (vorinostat, bortezomib). | Diffuse Large B-Cell Lymphoma (DLBCL): Treatment (vorinostat, bortezomib). |
| Measure Participants | 7 | 0 | 3 |
| Median (Full Range) [months] |
4.2
|
2.1
|
| Title | Duration of Stable Disease |
|---|---|
| Description | Median duration of stable disease per cohort. |
| Time Frame | Up to 9 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants with stable disease. |
| Arm/Group Title | Cohort A - MCL | Cohort B - MCL | Cohort C - DLBCL |
|---|---|---|---|
| Arm/Group Description | Mantle Cell Lymphoma (MCL): Treatment (vorinostat, bortezomib). | Mantle Cell Lymphoma MCL: Treatment (vorinostat, bortezomib). | Diffuse Large B-Cell Lymphoma (DLBCL): Treatment (vorinostat, bortezomib). |
| Measure Participants | 5 | 2 | 8 |
| Median (Full Range) [months] |
3.8
|
3.8
|
1.3
|
Adverse Events
| Time Frame | 5 years | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was used for reporting adverse events until April 1, 2011, when mandatory conversion to CTCAE v4.0 supervened. Response was assessed using the Revised Response Criteria for Malignant Lymphoma. | |||||
| Arm/Group Title | Cohort A - MCL | Cohort B - MCL | Cohort C - DLBCL | |||
| Arm/Group Description | Mantle Cell Lymphoma (MCL): Treatment (vorinostat, bortezomib). | Mantle Cell Lymphoma MCL: Treatment (vorinostat, bortezomib). | Diffuse Large B-Cell Lymphoma (DLBCL): Treatment (vorinostat, bortezomib). | |||
All Cause Mortality |
||||||
| Cohort A - MCL | Cohort B - MCL | Cohort C - DLBCL | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/22 (0%) | 0/4 (0%) | 4/39 (10.3%) | |||
Serious Adverse Events |
||||||
| Cohort A - MCL | Cohort B - MCL | Cohort C - DLBCL | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/22 (40.9%) | 1/4 (25%) | 22/39 (56.4%) | |||
| Blood and lymphatic system disorders | ||||||
| Anemia | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Cardiac disorders | ||||||
| Myocardial infarction | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Sinus bradycardia | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Sinus tachycardia | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Ventricular arrhythmia | 0/22 (0%) | 0 | 1/4 (25%) | 1 | 0/39 (0%) | 0 |
| Eye disorders | ||||||
| Dry Eye | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Eye disorders - Other, Chalazion | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Abdominal pain | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 2 |
| Diarrhea | 3/22 (13.6%) | 3 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Gastritis | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Gastrointestinal disorders - Other, Duodenitis | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Gastrointestinal disorders - Other, Cramping | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Lower gastrointestinal hemorrhage | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Nausea | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 2/39 (5.1%) | 2 |
| Vomiting | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 3/39 (7.7%) | 3 |
| General disorders | ||||||
| Multi-organ failure - Death | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Multi-organ failure | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Chills | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Edema limbs | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Fatigue | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Fever | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Non-cardiac chest pain | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Pain | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 2/39 (5.1%) | 2 |
| Infections and infestations | ||||||
| Appendicitis | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Infectionsand infestations - Other | 2/22 (9.1%) | 2 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Skin infection | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Wound infection | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Investigations | ||||||
| Creatinine increased | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Ejection fraction decreased | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Electrocardiogram QT corrected interval prolonged | 0/22 (0%) | 0 | 1/4 (25%) | 1 | 1/39 (2.6%) | 2 |
| Neutrophil count decreased | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Platelet count decreased | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 6/39 (15.4%) | 7 |
| Metabolism and nutrition disorders | ||||||
| Dehydration | 2/22 (9.1%) | 3 | 0/4 (0%) | 0 | 3/39 (7.7%) | 3 |
| Hypercalcemia | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 2/39 (5.1%) | 3 |
| Hypokalemia | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Hyponatremia | 2/22 (9.1%) | 2 | 0/4 (0%) | 0 | 1/39 (2.6%) | 2 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Neoplasms benign, malignant and unspecified - Death | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Tumor pain | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 2/39 (5.1%) | 2 |
| Nervous system disorders | ||||||
| Dizziness | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Headache | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 2/39 (5.1%) | 2 |
| Nervous system disorders - Other | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Peripheral sensory neuropathy | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Syncope | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Psychiatric disorders | ||||||
| Confusion | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 2/39 (5.1%) | 2 |
| Renal and urinary disorders | ||||||
| Acute kidney injury | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 2/39 (5.1%) | 2 |
| Urinary incontinence | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Adult respiratory distress syndrome | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 2/39 (5.1%) | 2 |
| Dyspnea | 0/22 (0%) | 0 | 1/4 (25%) | 1 | 6/39 (15.4%) | 6 |
| Hypoxia | 1/22 (4.5%) | 2 | 1/4 (25%) | 1 | 0/39 (0%) | 0 |
| Pneumonitis | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Pulmonary fibrosis | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Vascular disorders | ||||||
| Hypotension | 2/22 (9.1%) | 2 | 0/4 (0%) | 0 | 3/39 (7.7%) | 3 |
| Thromboembolic event | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 2/39 (5.1%) | 2 |
Other (Not Including Serious) Adverse Events |
||||||
| Cohort A - MCL | Cohort B - MCL | Cohort C - DLBCL | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 22/22 (100%) | 4/4 (100%) | 39/39 (100%) | |||
| Blood and lymphatic system disorders | ||||||
| Anemia | 7/22 (31.8%) | 26 | 1/4 (25%) | 1 | 20/39 (51.3%) | 70 |
| Blood and lymphatic system disorders - Other, specify | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Hemolysis | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 2 |
| Thrombotic thrombocytopenic purpura | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Cardiac disorders | ||||||
| Sinus tachycardia | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 3/39 (7.7%) | 4 |
| Sinus bradycardia | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Atrial fibrillation | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Ear and labyrinth disorders | ||||||
| Hearing impaired | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Vertigo | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Eye disorders | ||||||
| Dry eye | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Blurred vision | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Conjunctivitis | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Eye disorders - Other, specify | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Eyelid function disorder | 0/22 (0%) | 0 | 1/4 (25%) | 1 | 0/39 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Diarrhea | 20/22 (90.9%) | 54 | 2/4 (50%) | 2 | 24/39 (61.5%) | 46 |
| Nausea | 14/22 (63.6%) | 33 | 2/4 (50%) | 2 | 20/39 (51.3%) | 47 |
| Vomiting | 10/22 (45.5%) | 16 | 0/4 (0%) | 0 | 14/39 (35.9%) | 24 |
| Constipation | 7/22 (31.8%) | 8 | 1/4 (25%) | 1 | 12/39 (30.8%) | 15 |
| Abdominal pain | 5/22 (22.7%) | 6 | 1/4 (25%) | 1 | 10/39 (25.6%) | 12 |
| Dyspepsia | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 5/39 (12.8%) | 5 |
| Flatulence | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 3/39 (7.7%) | 3 |
| Stomach pain | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 2/39 (5.1%) | 2 |
| Abdominal distension | 2/22 (9.1%) | 2 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Dry mouth | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Gastrointestinal disorders - Other, specify | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Lower gastrointestinal hemorrhage | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Dysphagia | 0/22 (0%) | 0 | 1/4 (25%) | 1 | 0/39 (0%) | 0 |
| Gastrointestinal pain | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Gastroparesis | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Ileus | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Mucositis oral | 0/22 (0%) | 0 | 1/4 (25%) | 1 | 0/39 (0%) | 0 |
| Oral pain | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| General disorders | ||||||
| Fatigue | 18/22 (81.8%) | 39 | 1/4 (25%) | 4 | 22/39 (56.4%) | 48 |
| Chills | 7/22 (31.8%) | 10 | 0/4 (0%) | 0 | 2/39 (5.1%) | 3 |
| Edema limbs | 2/22 (9.1%) | 2 | 0/4 (0%) | 0 | 5/39 (12.8%) | 6 |
| Fever | 2/22 (9.1%) | 3 | 0/4 (0%) | 0 | 6/39 (15.4%) | 9 |
| Pain | 2/22 (9.1%) | 2 | 0/4 (0%) | 0 | 6/39 (15.4%) | 7 |
| Malaise | 2/22 (9.1%) | 3 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Non-cardiac chest pain | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Edema trunk | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Facial pain | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Irritability | 0/22 (0%) | 0 | 1/4 (25%) | 1 | 0/39 (0%) | 0 |
| Hepatobiliary disorders | ||||||
| Gallbladder fistula | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Immune system disorders | ||||||
| Allergic reaction | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Autoimmune disorder | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Infections and infestations | ||||||
| Infections and infestations - Other, specify | 2/22 (9.1%) | 2 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Papulopustular rash | 2/22 (9.1%) | 2 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Sinusitis | 1/22 (4.5%) | 3 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Hepatitis viral | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Lung infection | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Mucosal infection | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Pharyngitis | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Sepsis | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Upper respiratory infection | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Urinary tract infection | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Wound infection | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Injury, poisoning and procedural complications | ||||||
| Bruising | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Injury, poisoning and procedural complications - Other, specify | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Vascular access complication | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Wound dehiscence | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Investigations | ||||||
| Platelet count decreased | 18/22 (81.8%) | 126 | 3/4 (75%) | 5 | 26/39 (66.7%) | 141 |
| Lymphocyte count decreased | 11/22 (50%) | 30 | 1/4 (25%) | 1 | 20/39 (51.3%) | 65 |
| White blood cell decreased | 13/22 (59.1%) | 32 | 1/4 (25%) | 1 | 14/39 (35.9%) | 65 |
| Neutrophil count decreased | 10/22 (45.5%) | 19 | 0/4 (0%) | 0 | 12/39 (30.8%) | 32 |
| Creatinine increased | 7/22 (31.8%) | 19 | 1/4 (25%) | 3 | 12/39 (30.8%) | 42 |
| Aspartate aminotransferase increased | 3/22 (13.6%) | 6 | 0/4 (0%) | 0 | 7/39 (17.9%) | 10 |
| Alanine aminotransferase increased | 3/22 (13.6%) | 5 | 0/4 (0%) | 0 | 5/39 (12.8%) | 9 |
| Alkaline phosphatase increased | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 6/39 (15.4%) | 8 |
| Electrocardiogram QT corrected interval prolonged | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Weight loss | 3/22 (13.6%) | 3 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Investigations - Other, specify | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 2/39 (5.1%) | 6 |
| INR increased | 0/22 (0%) | 0 | 1/4 (25%) | 1 | 1/39 (2.6%) | 1 |
| Weight gain | 0/22 (0%) | 0 | 1/4 (25%) | 1 | 1/39 (2.6%) | 1 |
| Activated partial thromboplastin time prolonged | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Blood bilirubin increased | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Cardiac troponin T increased | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 3 |
| Cholesterol high | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| CPK increased | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 2 |
| Metabolism and nutrition disorders | ||||||
| Anorexia | 11/22 (50%) | 11 | 0/4 (0%) | 0 | 15/39 (38.5%) | 23 |
| Hyperglycemia | 5/22 (22.7%) | 7 | 3/4 (75%) | 6 | 14/39 (35.9%) | 25 |
| Hyponatremia | 5/22 (22.7%) | 14 | 0/4 (0%) | 0 | 11/39 (28.2%) | 15 |
| Hypocalcemia | 5/22 (22.7%) | 11 | 0/4 (0%) | 0 | 10/39 (25.6%) | 17 |
| Dehydration | 2/22 (9.1%) | 2 | 0/4 (0%) | 0 | 4/39 (10.3%) | 4 |
| Hypoalbuminemia | 2/22 (9.1%) | 2 | 0/4 (0%) | 0 | 9/39 (23.1%) | 12 |
| Hypokalemia | 3/22 (13.6%) | 5 | 0/4 (0%) | 0 | 6/39 (15.4%) | 17 |
| Hypoglycemia | 2/22 (9.1%) | 4 | 0/4 (0%) | 0 | 6/39 (15.4%) | 15 |
| Hypomagnesemia | 2/22 (9.1%) | 3 | 0/4 (0%) | 0 | 6/39 (15.4%) | 9 |
| Hypercalcemia | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 3/39 (7.7%) | 4 |
| Hyperkalemia | 3/22 (13.6%) | 3 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Hypophosphatemia | 1/22 (4.5%) | 3 | 0/4 (0%) | 0 | 3/39 (7.7%) | 4 |
| Acidosis | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 1/39 (2.6%) | 4 |
| Hyperuricemia | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 2/39 (5.1%) | 2 |
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 3/22 (13.6%) | 3 | 1/4 (25%) | 1 | 6/39 (15.4%) | 6 |
| Pain in extremity | 5/22 (22.7%) | 8 | 0/4 (0%) | 0 | 3/39 (7.7%) | 6 |
| Generalized muscle weakness | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 4/39 (10.3%) | 4 |
| Myalgia | 2/22 (9.1%) | 2 | 0/4 (0%) | 0 | 2/39 (5.1%) | 2 |
| Neck pain | 3/22 (13.6%) | 5 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Arthralgia | 1/22 (4.5%) | 2 | 1/4 (25%) | 4 | 0/39 (0%) | 0 |
| Flank pain | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Bone pain | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Joint range of motion decreased | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Muscle weakness lower limb | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Muscle weakness upper limb | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Nervous system disorders | ||||||
| Peripheral sensory neuropathy | 10/22 (45.5%) | 20 | 1/4 (25%) | 2 | 10/39 (25.6%) | 12 |
| Dizziness | 12/22 (54.5%) | 16 | 1/4 (25%) | 1 | 7/39 (17.9%) | 7 |
| Headache | 2/22 (9.1%) | 2 | 1/4 (25%) | 1 | 11/39 (28.2%) | 15 |
| Dysgeusia | 3/22 (13.6%) | 3 | 0/4 (0%) | 0 | 1/39 (2.6%) | 2 |
| Paresthesia | 2/22 (9.1%) | 2 | 0/4 (0%) | 0 | 2/39 (5.1%) | 2 |
| Peripheral motor neuropathy | 1/22 (4.5%) | 2 | 0/4 (0%) | 0 | 2/39 (5.1%) | 2 |
| Nervous system disorders - Other, specify | 1/22 (4.5%) | 3 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Syncope | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Cognitive disturbance | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Psychiatric disorders | ||||||
| Anxiety | 4/22 (18.2%) | 5 | 0/4 (0%) | 0 | 5/39 (12.8%) | 6 |
| Insomnia | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 3/39 (7.7%) | 3 |
| Confusion | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Depression | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 3/39 (7.7%) | 4 |
| Agitation | 0/22 (0%) | 0 | 1/4 (25%) | 2 | 1/39 (2.6%) | 1 |
| Restlessness | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Renal and urinary disorders | ||||||
| Acute kidney injury | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Proteinuria | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 2/39 (5.1%) | 2 |
| Renal and urinary disorders - Other, specify | 0/22 (0%) | 0 | 1/4 (25%) | 1 | 1/39 (2.6%) | 1 |
| Urinary frequency | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Urinary incontinence | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 2/39 (5.1%) | 2 |
| Urinary tract pain | 0/22 (0%) | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 | |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Dyspnea | 3/22 (13.6%) | 6 | 0/4 (0%) | 0 | 12/39 (30.8%) | 15 |
| Cough | 2/22 (9.1%) | 3 | 2/4 (50%) | 2 | 7/39 (17.9%) | 8 |
| Nasal congestion | 1/22 (4.5%) | 2 | 0/4 (0%) | 0 | 2/39 (5.1%) | 2 |
| Productive cough | 1/22 (4.5%) | 2 | 0/4 (0%) | 0 | 1/39 (2.6%) | 2 |
| Allergic rhinitis | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Bronchopulmonary hemorrhage | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Pleural effusion | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Pneumonitis | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Sore throat | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||
| Pruritus | 2/22 (9.1%) | 3 | 0/4 (0%) | 0 | 4/39 (10.3%) | 4 |
| Skin and subcutaneous tissue disorders - Other, specify | 3/22 (13.6%) | 3 | 1/4 (25%) | 1 | 2/39 (5.1%) | 2 |
| Rash maculo-papular | 2/22 (9.1%) | 3 | 0/4 (0%) | 0 | 3/39 (7.7%) | 3 |
| Hyperhidrosis | 2/22 (9.1%) | 2 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Alopecia | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Rash acneiform | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Dry skin | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Palmar-plantar erythrodysesthesia syndrome | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Periorbital edema | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Purpura | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Scalp pain | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
| Skin induration | 0/22 (0%) | 0 | 1/4 (25%) | 1 | 0/39 (0%) | 0 |
| Vascular disorders | ||||||
| Hypotension | 3/22 (13.6%) | 7 | 0/4 (0%) | 0 | 4/39 (10.3%) | 4 |
| Hypertension | 2/22 (9.1%) | 4 | 1/4 (25%) | 1 | 1/39 (2.6%) | 1 |
| Thromboembolic event | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 1/39 (2.6%) | 3 |
| Lymphedema | 0/22 (0%) | 0 | 0/4 (0%) | 0 | 1/39 (2.6%) | 1 |
| Vascular disorders - Other, specify | 1/22 (4.5%) | 1 | 0/4 (0%) | 0 | 0/39 (0%) | 0 |
Limitations/Caveats
Cohort C met the 1st-stage efficacy endpoint to proceed to the 2nd stage but was closed with evidence that the 2nd-stage efficacy endpoint could not be achieved.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Dr. Beata Holkova |
|---|---|
| Organization | Massey Cancer Center, Virginia Commonwealth University |
| Phone | 804-628-2581 |
| bholkova@mcvh-vcu.edu |
Responsible Party:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00703664
Other Study ID Numbers:
- NCI-2009-00275
- NCI-2009-00275
- CDR0000598308
- MCC-15428
- 8064
- N01CM00071
- N01CM00100
- N01CM62201
- N01CM62204
- N01CM62208
- P30CA076292
First Posted:
Jun 23, 2008
Last Update Posted:
Aug 7, 2018
Last Verified:
Jul 1, 2018