Trial Outcomes & Findings for Veltuzumab and Milatuzumab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (NCT NCT00989586)

NCT ID: NCT00989586

Last Updated: 2017-02-06

Results Overview

Dose-limiting toxicity was assessed during induction therapy for phase I.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 35 participants
• Primary outcome timeframe: up to 2 years
• Results posted on: 2017-02-06

Participant Flow

Participant milestones

Measure	Phase I Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4. milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with	Phase II Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction. veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks
Overall Study STARTED	18	17
Overall Study COMPLETED	18	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Veltuzumab and Milatuzumab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Baseline characteristics by cohort

Measure	Phase I n=18 Participants Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4. milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with	Phase II n=17 Participants Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction. veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks	Total n=35 Participants Total of all reporting groups
Age, Continuous	65 years n=5 Participants	63 years n=7 Participants	63 years n=5 Participants
Gender Female	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Gender Male	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment United States	18 patients n=5 Participants	17 patients n=7 Participants	35 patients n=5 Participants

PRIMARY outcome

Timeframe: up to 2 years

Dose-limiting toxicity was assessed during induction therapy for phase I.

Outcome measures

Measure	Phase I n=18 Participants Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4. milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with	Phase II Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction. veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks
Dose Limiting Toxicity (DLT) for Phase I Patients	0 patients	—

PRIMARY outcome

Timeframe: up to 2 years

Patients received a fixed dose of Veltuzumab IV 200 mg/m2 and Milatuzumab was dose escalated

Outcome measures

Measure	Phase I n=18 Participants Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4. milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with	Phase II Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction. veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks
Maximum Tolerated Dose (MTD)for Phase I Patients	20 mg/kg	—

PRIMARY outcome

Timeframe: Up to 2 years

Per International Response Criteria (Cheson JCO 2007) for target lesions and assessed by CT, MRI or PET: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses; Overall Response (OR) = CR + PR.

Outcome measures

Measure	Phase I n=34 Participants Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4. milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with	Phase II Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction. veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks
Overall Objective Response Rate	24 percent of patients	—

SECONDARY outcome

Timeframe: up to 2 years

Progression is defined using International Response Criteria (Cheson JCO 2007), as a >= 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or at least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis, or the size of other lesions (eg, splenic or hepatic nodules), or the appearance of new lesions.

Outcome measures

Measure	Phase I n=34 Participants Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4. milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with	Phase II Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction. veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks
Progression-free Survival (PFS)	4.7 months Interval 2.2 to 9.3	—

SECONDARY outcome

Timeframe: up to 2 years

Population: This data is not available due to analysis was not performed. The response rate was to low for the analysis to yield results to report for this trial.

The relationship between overall response rate (ORR) and Fcy receptor status. A two-sided chi-square test or exact test with α = 0.05 will be used to test the homogeneity of the ORR among the three genotypes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 1 year

Population: This data is not available due to analysis was not performed. The response rate was to low for the analysis to yield results to report for this trial.

Quantitative T-, B-, and NK- cell subsets will be assessed using flow cytometry to quantify the percentage and absolute number of cells expressing CD4, CD8, CD56, CD16, CD19, and CD20 at screening, after induction, and prior to the start of therapy on day 1 week 12, day 1 week 28, and then every 4 months for one year.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0, 24, 48, 72, 96 and 120 hours post-does

Population: AUC0-∞ for patients dosed at 20 mg/kg

Evaluation of pharmacokinetics (Pk) of veltuzumab and milatuzumab was performed for patients included in the trial. Statistically, descriptive data of PK parameters will be computed. Relationships between such parameters as dose and AUC, volume of distribution, clearance, and others will be evaluated, but be preliminary due to the small sample size.

Outcome measures

Measure	Phase I n=17 Participants Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4. milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with	Phase II Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction. veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks
Access Pharmacokinetics Through AUC0-∞ (Area Under Curve)	422 d*ug/ml Standard Deviation 121	—

SECONDARY outcome

Timeframe: 0, 24, 48, 72, 96 and 120 hours post-dose

Population: Cmax for patients dosed at 20 mg/kg

Evaluation of pharmacokinetics of veltuzumab and milatuzumab was performed for patients included in the trial. Statistically, descriptive data of PK parameters will be computed. Relationships between such parameters as dose and AUC, volume of distribution, clearance, and others will be evaluated, but be preliminary due to the small sample size.

Outcome measures

Measure	Phase I n=17 Participants Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4. milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with	Phase II Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction. veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks
Access Pharmacokinetics Through Cmax	480 ug/ml Standard Deviation 116	—

SECONDARY outcome

Timeframe: up to 36 weeks

Population: HAHA titres were assayed for patients in Phase I and Phase II

Patients will be monitored for the development of human anti-veltuzumab antibodies and human anti-milatuzumab antibodies (HAHA).

Outcome measures

Measure	Phase I n=33 Participants Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4. milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with	Phase II Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction. veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks
Monitor Human Anti-veltuzumab Antibodies and Human Anti-milatuzumab (HAHA) anti-veltuzumab antibodies	1 patients	—
Monitor Human Anti-veltuzumab Antibodies and Human Anti-milatuzumab (HAHA) anti-milatuzumab antibodies	0 patients	—

Adverse Events

All Patients From Phase I and Phase II

Serious events: 3 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Patients From Phase I and Phase II n=35 participants at risk Toxicities were graded according to NCI Common Toxicity Criteria for Adverse Events version 3.0 and classified as either unrelated, unlikely, possibly, probably or definitely related to study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolus	5.7% 2/35 • Number of events 2 Adverse event grading was done according to NCI CTCAE version 3.0 as classified either possibly, probably, or definitely related to study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonia	2.9% 1/35 • Number of events 1 Adverse event grading was done according to NCI CTCAE version 3.0 as classified either possibly, probably, or definitely related to study treatment.
Injury, poisoning and procedural complications Infusion Reaction	8.6% 3/35 • Number of events 3 Adverse event grading was done according to NCI CTCAE version 3.0 as classified either possibly, probably, or definitely related to study treatment.
Blood and lymphatic system disorders Bacteremia	2.9% 1/35 • Number of events 1 Adverse event grading was done according to NCI CTCAE version 3.0 as classified either possibly, probably, or definitely related to study treatment.
Cardiac disorders Supraventricular tachycardia	2.9% 1/35 • Number of events 1 Adverse event grading was done according to NCI CTCAE version 3.0 as classified either possibly, probably, or definitely related to study treatment.
General disorders Death	5.7% 2/35 • Number of events 2 Adverse event grading was done according to NCI CTCAE version 3.0 as classified either possibly, probably, or definitely related to study treatment.
General disorders Fatigue	2.9% 1/35 • Number of events 1 Adverse event grading was done according to NCI CTCAE version 3.0 as classified either possibly, probably, or definitely related to study treatment.
Metabolism and nutrition disorders Hyperbilirubinemia	2.9% 1/35 • Number of events 1 Adverse event grading was done according to NCI CTCAE version 3.0 as classified either possibly, probably, or definitely related to study treatment.
General disorders Fever without neutropenia	2.9% 1/35 • Number of events 1 Adverse event grading was done according to NCI CTCAE version 3.0 as classified either possibly, probably, or definitely related to study treatment.

Other adverse events

Measure	All Patients From Phase I and Phase II n=35 participants at risk Toxicities were graded according to NCI Common Toxicity Criteria for Adverse Events version 3.0 and classified as either unrelated, unlikely, possibly, probably or definitely related to study treatment.
Blood and lymphatic system disorders Leukopenia	22.9% 8/35 • Number of events 8 Adverse event grading was done according to NCI CTCAE version 3.0 as classified either possibly, probably, or definitely related to study treatment.
Blood and lymphatic system disorders Neutropenia	14.3% 5/35 • Number of events 5 Adverse event grading was done according to NCI CTCAE version 3.0 as classified either possibly, probably, or definitely related to study treatment.
Blood and lymphatic system disorders Lymphopenia	54.3% 19/35 • Number of events 19 Adverse event grading was done according to NCI CTCAE version 3.0 as classified either possibly, probably, or definitely related to study treatment.
Blood and lymphatic system disorders Anemia	14.3% 5/35 • Number of events 5 Adverse event grading was done according to NCI CTCAE version 3.0 as classified either possibly, probably, or definitely related to study treatment.
Blood and lymphatic system disorders Thrombocytopenia	20.0% 7/35 • Number of events 7 Adverse event grading was done according to NCI CTCAE version 3.0 as classified either possibly, probably, or definitely related to study treatment.
Infections and infestations Infection	14.3% 5/35 • Number of events 5 Adverse event grading was done according to NCI CTCAE version 3.0 as classified either possibly, probably, or definitely related to study treatment.
Injury, poisoning and procedural complications Infusion Reactions	60.0% 21/35 • Number of events 21 Adverse event grading was done according to NCI CTCAE version 3.0 as classified either possibly, probably, or definitely related to study treatment.
Gastrointestinal disorders Nausea	5.7% 2/35 • Number of events 2 Adverse event grading was done according to NCI CTCAE version 3.0 as classified either possibly, probably, or definitely related to study treatment.
Gastrointestinal disorders Diarrhea	5.7% 2/35 • Number of events 2 Adverse event grading was done according to NCI CTCAE version 3.0 as classified either possibly, probably, or definitely related to study treatment.
General disorders Fatigue	8.6% 3/35 • Number of events 3 Adverse event grading was done according to NCI CTCAE version 3.0 as classified either possibly, probably, or definitely related to study treatment.
Metabolism and nutrition disorders Hyperglycemia	11.4% 4/35 • Number of events 4 Adverse event grading was done according to NCI CTCAE version 3.0 as classified either possibly, probably, or definitely related to study treatment.
General disorders Chills	5.7% 2/35 • Number of events 2 Adverse event grading was done according to NCI CTCAE version 3.0 as classified either possibly, probably, or definitely related to study treatment.
Metabolism and nutrition disorders Hypophosphatemia	5.7% 2/35 • Number of events 2 Adverse event grading was done according to NCI CTCAE version 3.0 as classified either possibly, probably, or definitely related to study treatment.

Additional Information

Beth Christian

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-8858

Email: beth.christian@osumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place