Gemcitabine and Bendamustine in Patients With Relapsed or Refractory Hodgkin's Lymphoma
Sponsor
Beth Christian (Other)
Overall Status
Completed
CT.gov ID
NCT01535924
Collaborator
(none)
26
2
1
84.4
13
0.2
Study Details
Study Description
Brief Summary
This phase I/II trial studies the side effects and best dose of bendamustine hydrochloride when given together with gemcitabine hydrochloride and to see how well it works in treating patients with relapsed or refractory Hodgkin lymphoma. Drugs used in chemotherapy, such as gemcitabine hydrochloride and bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug, combination chemotherapy, may kill more cancer cells.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
PRIMARY OBJECTIVES:
-
To evaluate the toxicity and determine the maximum tolerated dose (MTD) of combined bendamustine (bendamustine hydrochloride) and gemcitabine (gemcitabine hydrochloride) in patients with relapsed or refractory Hodgkin's lymphoma.
-
To determine the overall response rate of bendamustine and gemcitabine in patients with relapsed and refractory Hodgkin's lymphoma.
SECONDARY OBJECTIVES:
- To determine whether therapy with bendamustine in the setting of relapsed or refractory Hodgkin's lymphoma will impact future stem cell collection.
OUTLINE: This is a phase I, dose-escalation study of bendamustine hydrochloride followed by a phase II study.
Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1 and 2. Treatment repeats every 21-28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3-6 months for 2 years, then every 6 months for up to 3 years.
Study Design
Study Type:
Interventional
Actual Enrollment
:
26 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I/II Study Of Gemcitabine And Bendamustine In Patients With Relapsed Or Refractory Hodgkin's Lymphoma
Actual Study Start Date
:
Feb 9, 2012
Actual Primary Completion Date
:
Feb 20, 2019
Actual Study Completion Date
:
Feb 20, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment (combination chemotherapy) Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1 and 2. Treatment repeats every 21-28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
Drug: gemcitabine hydrochloride
Given IV
Other Names:
Drug: bendamustine hydrochloride
Given IV
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Adverse Events in Terms of Dose-limiting Toxicity (DLT) and MTD of Bendamustine Hydrochloride (Phase I) [up to 5 years]
Dose limiting toxicity will be defined during cycle 1 only of the phase I trial. Hematologic and Infectious Dose Limiting Toxicities include: Grade 3 febrile neutropenia persisting> 7 days, Grade 4 infection or febrile neutropenia. Treatment delay>14 days due to grade 3-4 neutropenia or thrombocytopenia. Non-Hematological Dose Limiting Toxicities include: any Grade 3 or 4 non-hematologic toxicity related to study treatment with the exception of nausea or vomiting, alopecia, or electrolyte/glucose abnormalities that are correctable within 72 hours.
Secondary Outcome Measures
- Overall Response Rate (ORR) of Bendamustine Hydrochloride and Gemcitabine Hydrochloride in Patients With Relapsed or Refractory Hodgkin Lymphoma (Phase II) [up to 5 years]
Tested using Simon's two-stage Minimax design. Descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data) and graphical analyses will be used for all correlative laboratory parameters. The associations between correlative laboratory parameters and clinical response will be evaluated using two sample t test or Fisher's exact test, whichever is appropriate.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Histologically documented Classical Hodgkin's lymphoma that is recurrent or refractory after standard chemotherapy; core biopsies are acceptable if they contain adequate tissue for primary diagnosis and immunophenotyping; bone marrow biopsies as the sole means of diagnosis are not acceptable
-
Patients with Hodgkin's lymphoma may have one of the following World Health
Organization subtypes:
-
Nodular sclerosis Hodgkin's lymphoma
-
Lymphocyte-rich Hodgkin's lymphoma
-
Mixed cellularity Hodgkin's lymphoma
-
Lymphocyte depletion Hodgkin's lymphoma
-
Nodular lymphocyte predominant Hodgkin's lymphoma
-
Patients must have relapsed or progressed after at least one prior therapy
-
Patients with relapsed or refractory disease following stem cell transplantation are permitted
-
No prior treatment with bendamustine; prior therapy with gemcitabine is permitted
-
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
-
Measurable disease must be present either on physical examination or imaging studies; non-measurable disease alone is not acceptable
-
Measurable disease: lesions that can be accurately measured in at least two dimensions as >= 1.0 x 1.0 cm by computerized tomography (CT), PET/CT (positron emission tomography/CT), or magnetic resonance imaging (MRI)
-
Non-measurable disease: all other lesions, including small lesions (less than 1.0 x 1.0 cm) and truly non-measurable lesions; lesions that are considered non-measurable include the following:
-
Bone lesions (lesions if present should be noted)
-
Ascites
-
Pleural/pericardial effusion
-
Lymphangitis cutis/pulmonis
-
Bone marrow (involvement by Hodgkin's lymphoma should be noted)
-
Non-pregnant and non-nursing; due to the teratogenic potential of these agents, pregnant or nursing patients may not be enrolled; women and men of reproductive potential should agree to use an effective means of birth control
-
Patients with human immunodeficiency virus (HIV) infection are eligible; patients with HIV infection must meet the following: No evidence of co-infection with hepatitis B or C; cluster of differentiation (CD)4+ count >= 400/mm; no evidence of resistant strains of HIV; on anti-HIV therapy with an HIV viral load < 50 copies HIV ribonucleic acid (RNA)/mL; no history of acquired immune deficiency syndrome (AIDS) defining conditions
-
Granulocytes >= 1000/μl
-
Platelet count >= 75,000/μl
-
Creatinine =< 20 mg/dL
-
Bilirubin =< 2.0 mg/dL
-
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.0 x upper limits of normal
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Emory University | Atlanta | Georgia | United States | 30322 |
| 2 | Ohio State University Medical Center | Columbus | Ohio | United States | 43210 |
Sponsors and Collaborators
- Beth Christian
Investigators
- Principal Investigator: Beth Christian, MD, Ohio State University
Study Documents (Full-Text)
More Information
Additional Information:
Publications
Responsible Party:
Beth Christian,
Principal Investigator,
Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01535924
Other Study ID Numbers:
- OSU-11015
- NCI-2012-00022
First Posted:
Feb 20, 2012
Last Update Posted:
Nov 19, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Beth Christian,
Principal Investigator,
Ohio State University Comprehensive Cancer Center
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The current study was conducted at the Ohio State University in Columbus, Ohio, and Emory University in Atlanta, Georgia. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Phase 1 (Dose Level 1) | Phase 1 (Dose Level 2) | Phase 1 (Dose Level 3) | Phase 1 (Dose Level 4) | Phase 2 (Dose Level 5) | Phase 2 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Dose Level 1: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 60 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. | Dose Level 2: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. | Dose Level 3: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 120 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. | Dose Level 4: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. | Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle. | Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle. |
| Period Title: Overall Study | ||||||
| STARTED | 3 | 3 | 3 | 4 | 6 | 7 |
| COMPLETED | 3 | 3 | 3 | 4 | 6 | 7 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Phase 1 (Dose Levels 1) | Phase 1 (Dose Levels 2) | Phase 1 (Dose Levels 3) | Phase 1 (Dose Levels 4) | Phase 2 (Dose Levels 5) | Phase 2 | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Dose Level 1: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 60 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV bendamustine hydrochloride: Given IV | Dose Level 2: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. | Dose Level 3: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 120 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. | Dose Level 4: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. | Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle. | Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle. | Total of all reporting groups |
| Overall Participants | 3 | 3 | 3 | 4 | 6 | 7 | 26 |
| Age (years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [years] |
38
(17.34)
|
38
(9.16)
|
35
(11.63)
|
50
(7.78)
|
33.33
(16.05)
|
37.14
(12.03)
|
38.19
(12.82)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
1
33.3%
|
1
33.3%
|
2
66.7%
|
1
25%
|
3
50%
|
2
28.6%
|
10
38.5%
|
| Male |
2
66.7%
|
2
66.7%
|
1
33.3%
|
3
75%
|
3
50%
|
5
71.4%
|
16
61.5%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
14.3%
|
1
3.8%
|
| Not Hispanic or Latino |
3
100%
|
3
100%
|
3
100%
|
4
100%
|
6
100%
|
6
85.7%
|
25
96.2%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
1
33.3%
|
1
33.3%
|
0
0%
|
0
0%
|
0
0%
|
2
7.7%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
1
33.3%
|
0
0%
|
1
16.7%
|
1
14.3%
|
3
11.5%
|
| White |
3
100%
|
2
66.7%
|
1
33.3%
|
4
100%
|
5
83.3%
|
6
85.7%
|
21
80.8%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (patients) [Number] | |||||||
| United States |
3
|
3
|
3
|
4
|
6
|
7
|
26
|
Outcome Measures
| Title | Adverse Events in Terms of Dose-limiting Toxicity (DLT) and MTD of Bendamustine Hydrochloride (Phase I) |
|---|---|
| Description | Dose limiting toxicity will be defined during cycle 1 only of the phase I trial. Hematologic and Infectious Dose Limiting Toxicities include: Grade 3 febrile neutropenia persisting> 7 days, Grade 4 infection or febrile neutropenia. Treatment delay>14 days due to grade 3-4 neutropenia or thrombocytopenia. Non-Hematological Dose Limiting Toxicities include: any Grade 3 or 4 non-hematologic toxicity related to study treatment with the exception of nausea or vomiting, alopecia, or electrolyte/glucose abnormalities that are correctable within 72 hours. |
| Time Frame | up to 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only patients in Phase I analyzed |
| Arm/Group Title | Phase 1 (Dose Levels 1) | Phase 1 (Dose Levels 2) | Phase 1 (Dose Levels 3) | Phase 1 (Dose Levels 4) | Phase 2 (Dose Levels 5) | Phase 2 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Dose Level 1: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 60 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV bendamustine hydrochloride: Given IV | Dose Level 2: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. | Dose Level 3: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 120 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. | Dose Level 4: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. | Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle. | Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle. |
| Measure Participants | 3 | 3 | 3 | 4 | 0 | 0 |
| Number [number of patients] |
0
|
0
|
0
|
0
|
| Title | Overall Response Rate (ORR) of Bendamustine Hydrochloride and Gemcitabine Hydrochloride in Patients With Relapsed or Refractory Hodgkin Lymphoma (Phase II) |
|---|---|
| Description | Tested using Simon's two-stage Minimax design. Descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data) and graphical analyses will be used for all correlative laboratory parameters. The associations between correlative laboratory parameters and clinical response will be evaluated using two sample t test or Fisher's exact test, whichever is appropriate. |
| Time Frame | up to 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only patients in Phase II analyzed |
| Arm/Group Title | Phase 1 (Dose Levels 1) | Phase 1 (Dose Levels 2) | Phase 1 (Dose Levels 3) | Phase 1 (Dose Levels 4) | Phase 2 (Dose Levels 5) | Phase 2 |
|---|---|---|---|---|---|---|
| Arm/Group Description | Dose Level 1: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 60 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV bendamustine hydrochloride: Given IV | Dose Level 2: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. | Dose Level 3: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 120 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. | Dose Level 4: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. | Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle. | Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle |
| Measure Participants | 0 | 0 | 0 | 0 | 6 | 7 |
| Number [percentage of patients] |
67
|
71
|
Adverse Events
| Time Frame | The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | |||||||||||
| Arm/Group Title | Phase 1 (Dose Levels 1) | Phase 1 (Dose Levels 2) | Phase 1 (Dose Levels 3) | Phase 1 (Dose Levels 4) | Phase 2 (Dose Levels 5) | Phase 2 | ||||||
| Arm/Group Description | Dose Level 1: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 60 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV bendamustine hydrochloride: Given IV | Dose Level 2: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. | Dose Level 3: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 120 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. | Dose Level 4: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. | Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle. | Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle. | ||||||
All Cause Mortality |
||||||||||||
| Phase 1 (Dose Levels 1) | Phase 1 (Dose Levels 2) | Phase 1 (Dose Levels 3) | Phase 1 (Dose Levels 4) | Phase 2 (Dose Levels 5) | Phase 2 | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/7 (0%) | ||||||
Serious Adverse Events |
||||||||||||
| Phase 1 (Dose Levels 1) | Phase 1 (Dose Levels 2) | Phase 1 (Dose Levels 3) | Phase 1 (Dose Levels 4) | Phase 2 (Dose Levels 5) | Phase 2 | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/3 (0%) | 3/3 (100%) | 0/3 (0%) | 4/4 (100%) | 1/6 (16.7%) | 1/7 (14.3%) | ||||||
| Eye disorders | ||||||||||||
| Eye Pain | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/7 (14.3%) | 1 |
| General disorders | ||||||||||||
| Fever | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/7 (14.3%) | 1 |
| Immune system disorders | ||||||||||||
| Immune Systems Disorder | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/7 (0%) | 0 |
| Infections and infestations | ||||||||||||
| Infection and Infestations | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/7 (0%) | 0 |
| Lung infection | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 1/6 (16.7%) | 1 | 0/7 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||
| Dehydration | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/7 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||
| Chronic Kidney Disease | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/7 (0%) | 0 |
| Intraoperative urinary injury | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/7 (14.3%) | 1 |
| Vascular disorders | ||||||||||||
| Hypotension | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/7 (0%) | 0 |
| Thromboembolic event | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/7 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||
| Phase 1 (Dose Levels 1) | Phase 1 (Dose Levels 2) | Phase 1 (Dose Levels 3) | Phase 1 (Dose Levels 4) | Phase 2 (Dose Levels 5) | Phase 2 | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/3 (100%) | 3/3 (100%) | 3/3 (100%) | 4/4 (100%) | 6/6 (100%) | 7/7 (100%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| Anemia | 2/3 (66.7%) | 3 | 2/3 (66.7%) | 4 | 3/3 (100%) | 3 | 2/4 (50%) | 2 | 6/6 (100%) | 7 | 7/7 (100%) | 9 |
| Platelet count decreased | 2/3 (66.7%) | 3 | 1/3 (33.3%) | 4 | 2/3 (66.7%) | 3 | 4/4 (100%) | 5 | 3/6 (50%) | 6 | 4/7 (57.1%) | 5 |
| Cardiac disorders | ||||||||||||
| Atrial fibrillation | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/7 (0%) | 0 |
| Palpitations | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/7 (0%) | 0 |
| Eye disorders | ||||||||||||
| Eye disorders - Other, specify | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/7 (0%) | 0 |
| Blurred vision | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/7 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||
| Abdominal Pain | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 2/7 (28.6%) | 2 |
| Constipation | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 2/7 (28.6%) | 2 |
| Diarrhea | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 2/4 (50%) | 2 | 1/6 (16.7%) | 2 | 0/7 (0%) | 0 |
| Gastroesophageal reflux disease | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/7 (14.3%) | 1 |
| Hemorrhoids | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/7 (14.3%) | 1 |
| Nausea | 2/3 (66.7%) | 2 | 3/3 (100%) | 11 | 2/3 (66.7%) | 4 | 4/4 (100%) | 6 | 4/6 (66.7%) | 5 | 5/7 (71.4%) | 5 |
| Vomiting | 1/3 (33.3%) | 1 | 2/3 (66.7%) | 4 | 2/3 (66.7%) | 2 | 2/4 (50%) | 5 | 3/6 (50%) | 6 | 2/7 (28.6%) | 2 |
| General disorders | ||||||||||||
| Chills | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/7 (14.3%) | 1 |
| Edema face | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/7 (0%) | 0 |
| Edema limbs | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/7 (14.3%) | 1 |
| Fatigue | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 4/7 (57.1%) | 4 |
| Fever | 3/3 (100%) | 3 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 3/4 (75%) | 3 | 1/6 (16.7%) | 1 | 0/7 (0%) | 0 |
| Immune system disorders | ||||||||||||
| Cytokine release syndrome | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/7 (0%) | 0 |
| Infections and infestations | ||||||||||||
| Bronchial infection | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/7 (0%) | 0 |
| Lung infection | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 2 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/7 (0%) | 0 |
| Sinusitis | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/7 (0%) | 0 |
| Upper respiratory infection | 0/3 (0%) | 0 | 2/3 (66.7%) | 2 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/7 (14.3%) | 1 |
| Investigations | ||||||||||||
| Alanine aminotransferase increased | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 2 | 1/3 (33.3%) | 2 | 2/4 (50%) | 2 | 3/6 (50%) | 5 | 2/7 (28.6%) | 4 |
| Alkaline phosphatase increased | 2/3 (66.7%) | 2 | 2/3 (66.7%) | 2 | 0/3 (0%) | 0 | 2/4 (50%) | 2 | 4/6 (66.7%) | 5 | 5/7 (71.4%) | 5 |
| Aspartate aminotransferase increased | 1/3 (33.3%) | 1 | 2/3 (66.7%) | 5 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 3/7 (42.9%) | 4 |
| Creatinine increased | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 1/7 (14.3%) | 1 |
| Lymphocyte count decreased | 3/3 (100%) | 3 | 3/3 (100%) | 9 | 3/3 (100%) | 4 | 4/4 (100%) | 4 | 6/6 (100%) | 7 | 7/7 (100%) | 10 |
| Neutrophil count decreased | 0/3 (0%) | 0 | 2/3 (66.7%) | 2 | 2/3 (66.7%) | 3 | 2/4 (50%) | 2 | 0/6 (0%) | 0 | 0/7 (0%) | 0 |
| White blood cell decreased | 2/3 (66.7%) | 2 | 1/3 (33.3%) | 1 | 3/3 (100%) | 5 | 1/4 (25%) | 1 | 1/6 (16.7%) | 1 | 3/7 (42.9%) | 3 |
| Metabolism and nutrition disorders | ||||||||||||
| Anorexia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 1/7 (14.3%) | 1 |
| Hyperglycemia | 2/3 (66.7%) | 2 | 2/3 (66.7%) | 3 | 2/3 (66.7%) | 3 | 3/4 (75%) | 3 | 2/6 (33.3%) | 2 | 3/7 (42.9%) | 4 |
| Hypokalemia | 1/3 (33.3%) | 2 | 1/3 (33.3%) | 3 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 3/6 (50%) | 5 | 1/7 (14.3%) | 1 |
| Hypomagnesemia | 0/3 (0%) | 0 | 1/3 (33.3%) | 2 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/7 (0%) | 0 |
| Hyponatremia | 0/3 (0%) | 0 | 2/3 (66.7%) | 3 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 3/6 (50%) | 3 | 3/7 (42.9%) | 4 |
| Hypoalbuminemia | 1/3 (33.3%) | 2 | 2/3 (66.7%) | 3 | 0/3 (0%) | 0 | 2/4 (50%) | 4 | 2/6 (33.3%) | 2 | 2/7 (28.6%) | 2 |
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Arthralgia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/7 (14.3%) | 1 |
| Back pain | 0/3 (0%) | 0 | 1/3 (33.3%) | 4 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 1/6 (16.7%) | 1 | 2/7 (28.6%) | 2 |
| Fall | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/7 (14.3%) | 1 |
| Nervous system disorders | ||||||||||||
| Dizziness | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 1/7 (14.3%) | 2 |
| Dysgeusia | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 0/7 (0%) | 0 |
| Headache | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/4 (50%) | 2 | 2/6 (33.3%) | 4 | 3/7 (42.9%) | 3 |
| Psychiatric disorders | ||||||||||||
| Anxiety | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 0/7 (0%) | 0 |
| Depression | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/7 (0%) | 0 |
| Insomnia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 4/7 (57.1%) | 4 |
| Renal and urinary disorders | ||||||||||||
| Chronic kidney disease | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/7 (0%) | 0 |
| Urinary tract pain | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/7 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Cough | 0/3 (0%) | 0 | 2/3 (66.7%) | 2 | 0/3 (0%) | 0 | 0/4 (0%) | 0 | 2/6 (33.3%) | 2 | 3/7 (42.9%) | 3 |
| Dyspnea | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 1/6 (16.7%) | 1 | 1/7 (14.3%) | 1 |
| Nasal congestion | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 1/6 (16.7%) | 1 | 0/7 (0%) | 0 |
| Productive cough | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 3 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/7 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||
| Pruritus | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 2/6 (33.3%) | 2 | 1/7 (14.3%) | 1 |
| Rash maculo-papular | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 3/7 (42.9%) | 3 |
| Hyperhidrosis | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/7 (0%) | 0 |
| Vascular disorders | ||||||||||||
| Flushing | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 1/7 (14.3%) | 1 |
| Hematoma | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 2 | 0/4 (0%) | 0 | 0/6 (0%) | 0 | 0/7 (0%) | 0 |
| Vascular disorders - Other, specify | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/4 (25%) | 1 | 0/6 (0%) | 0 | 3/7 (42.9%) | 3 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE 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. Beth Christian |
|---|---|
| Organization | The Ohio State University |
| Phone | 614-293-7807 |
| Beth.Christian@osumc.edu |
Responsible Party:
Beth Christian,
Principal Investigator,
Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01535924
Other Study ID Numbers:
- OSU-11015
- NCI-2012-00022
First Posted:
Feb 20, 2012
Last Update Posted:
Nov 19, 2021
Last Verified:
Oct 1, 2021