Trial Outcomes & Findings for A Phase II Study of Dasatinib in the Treatment of Relapsed or Plateau Phase Multiple Myeloma (NCT NCT00429949)

NCT ID: NCT00429949

Last Updated: 2014-08-29

Results Overview

CR requires all of the following: * Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune response reconstitution does not exclude CR. * \< 5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy is performed. If absence of monoclonal protein is sustained for 6 weeks it is not necessary to repeat the bone marrow. * No increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response). * Disappearance of soft tissue plasmacytoma PR requires all of the following: * 50% reduction in the level of the serum monoclonal paraprotein maintained for a minimum of 6 weeks. -Reduction in 24 hr urinary light chain excretion by either \> 90% or to \< 200 mg, maintained for a minimum of 6 weeks. * 50% reduction in the size of soft tissue plas

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 21 participants
• Primary outcome timeframe: Completion of treatment (median duration of therapy was 51 days)
• Results posted on: 2014-08-29

Participant Flow

Participant milestones

Measure	Dasatinib Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase II Study of Dasatinib in the Treatment of Relapsed or Plateau Phase Multiple Myeloma

Baseline characteristics by cohort

Measure	Dasatinib n=21 Participants Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants
Durie-Salmon Stage Stage IA	2 participants n=5 Participants
Durie-Salmon Stage Stage IIA	3 participants n=5 Participants
Durie-Salmon Stage Stage IIIA	15 participants n=5 Participants
Durie-Salmon Stage Stage IIIB	1 participants n=5 Participants
Prior therapies	3 therapies n=5 Participants
Prior therapies Immunomodulatory agents	19 participants n=5 Participants
Prior therapies Bortezomib	10 participants n=5 Participants
Prior therapies Anthracycline-containing regimens	12 participants n=5 Participants
Prior therapies Prior autologous stem cell transplant	19 participants n=5 Participants
Beta 2 microglobulin at study entry	2.7 mg/L n=5 Participants
Disease status at study entry Relapsed	14 participants n=5 Participants
Disease status at study entry Plateau phase	7 participants n=5 Participants
Paraprotein IgG	14 participants n=5 Participants
Paraprotein IgA	6 participants n=5 Participants
Paraprotein Light chain only	1 participants n=5 Participants
Cytogenetics Normal	12 participants n=5 Participants
Cytogenetics Del 13/13q	2 participants n=5 Participants
Cytogenetics Complex (including 1 with t4;14)	2 participants n=5 Participants
Cytogenetics t9;16	1 participants n=5 Participants
Cytogenetics Del 6p	1 participants n=5 Participants
Cytogenetics Unavailable	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Completion of treatment (median duration of therapy was 51 days)

CR requires all of the following:

• Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune response reconstitution does not exclude CR.
• < 5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy is performed. If absence of monoclonal protein is sustained for 6 weeks it is not necessary to repeat the bone marrow.
• No increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response).
• Disappearance of soft tissue plasmacytoma

PR requires all of the following:

• 50% reduction in the level of the serum monoclonal paraprotein maintained for a minimum of 6 weeks.

-Reduction in 24 hr urinary light chain excretion by either > 90% or to < 200 mg, maintained for a minimum of 6 weeks.

• 50% reduction in the size of soft tissue plas

Outcome measures

Measure	Dasatinib 70 mg BID n=21 Participants Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.	Dasatinib 100 mg BID n=6 Participants In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle.
Response Rate [Complete Response (CR) and Partial Response (PR)] Complete response	0 participants Interval 0.5 to 17.3	0 participants
Response Rate [Complete Response (CR) and Partial Response (PR)] Partial response	0 participants	1 participants

SECONDARY outcome

Timeframe: Completion of treatment (median duration of therapy was 51 days)

Population: Only one patient achieved a partial response.

Time to response is measured from the start of treatment until the first date that criteria are met for complete response or partial response.

Outcome measures

Measure	Dasatinib 70 mg BID n=1 Participants Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.	Dasatinib 100 mg BID In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle.
Time to Response	5 cycles	—

SECONDARY outcome

Timeframe: Up to 30 days following end of treatment (median duration of therapy was 51 days)

Toxicities were graded using the NCI Common Toxicity Criteria v3.0.

Outcome measures

Measure	Dasatinib 70 mg BID n=21 Participants Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.	Dasatinib 100 mg BID In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle.
Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) Grade III anemia	5 participants	—
Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) Grade III neutropenia	2 participants	—
Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) Grade III thrombocytopenia	2 participants	—
Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) Grade IV thrombocytopenia	3 participants	—
Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) Grade III epistaxis	2 participants	—
Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) Grade III gastrointestinal bleed	1 participants	—
Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) Grade III acute renal failure	2 participants	—
Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) Grade III headache	1 participants	—
Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) Grade III aphasia due to laryngeal plasmacytoma	1 participants	—
Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) Grade III neuropathy	1 participants	—
Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) Grade III fatigue	1 participants	—
Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) Grade III hypertension	1 participants	—
Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) Grade III diarrhea	1 participants	—
Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) Grade III leg/hip pain	1 participants	—
Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) Grade III generalized pain	3 participants	—
Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) Grade III hypercalcemia	1 participants	—
Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) Grade IV hypoglycemia	1 participants	—
Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) Grade IV hyperglycemia	1 participants	—
Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) Grade III pneumonia	3 participants	—
Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) Grade III pulmonary edema	1 participants	—
Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) Grade III pneumonitis/pulmonary infiltrates	2 participants	—
Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) Grade III pulmonary hypertension	1 participants	—
Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) Grade III hypoxia	1 participants	—
Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) Grade III dyspnea	1 participants	—
Safety and Tolerability of Dasatinib (Grade III-IV Toxicities) Grade IV dyspnea	1 participants	—

SECONDARY outcome

Timeframe: Completion of treatment (median duration of therapy was 51 days)

Population: Only one patient achieved a partial response.

Duration of response is measured from the first date that criteria are met for complete response or partial response until the first date that criteria for relapse or progressive disease are met.

Outcome measures

Measure	Dasatinib 70 mg BID n=1 Participants Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.	Dasatinib 100 mg BID In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle.
Duration of Response	3 cycles	—

SECONDARY outcome

Timeframe: Completion of treatment (median duration of therapy was 51 days)

EFS is defined as time from the start of the treatment until the first date that criteria for progressive disease are met, therapy was discontinued for toxicity, or death, whichever occurs first. Those patients alive will be censored at the date of last clinical contact. If progression is based upon serum or urine paraprotein measurements, which must be repeated for confirmation, event-free progression is still measured from the start of treatment until the first date that progression is detected.

Outcome measures

Measure	Dasatinib 70 mg BID n=7 Participants Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.	Dasatinib 100 mg BID In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle.
Event-free Survival (EFS) for Participants With Plateau Phase Disease	138 days Interval 73.8 to 202.2	—

SECONDARY outcome

Timeframe: Completion of treatment (median duration of therapy was 51 days)

EFS is defined as time from the start of the treatment until the first date that criteria for progressive disease are met, therapy was discontinued for toxicity, or death, whichever occurs first. Those patients alive will be censored at the date of last clinical contact. If progression is based upon serum or urine paraprotein measurements, which must be repeated for confirmation, event-free progression is still measured from the start of treatment until the first date that progression is detected.

Outcome measures

Measure	Dasatinib 70 mg BID n=14 Participants Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.	Dasatinib 100 mg BID In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle.
Event-free Survival (EFS) for Participants With Relapsed Disease	31 days Interval 23.7 to 38.3	—

Adverse Events

Dasatinib

Serious events: 6 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dasatinib n=21 participants at risk Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle. In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle.
General disorders Death due to disease progression	9.5% 2/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Respiratory, thoracic and mediastinal disorders Dyspnea	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
General disorders Fatigue	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Infections and infestations Febrile neutropenia	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Musculoskeletal and connective tissue disorders Hip pain	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Nervous system disorders Neuropathy - motor	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Respiratory, thoracic and mediastinal disorders Pleural effusion	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Infections and infestations Pneumonia	9.5% 2/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)

Other adverse events

Measure	Dasatinib n=21 participants at risk Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle. In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle.
Investigations Alkaline phosphatase	9.5% 2/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Metabolism and nutrition disorders Anorexia	33.3% 7/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Nervous system disorders Aphasia	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Musculoskeletal and connective tissue disorders Arthralgia	14.3% 3/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Nervous system disorders Ataxia	9.5% 2/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Musculoskeletal and connective tissue disorders Back pain	19.0% 4/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Psychiatric disorders Bad dreams	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Musculoskeletal and connective tissue disorders Bone ache	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Injury, poisoning and procedural complications Bruising	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Musculoskeletal and connective tissue disorders Buttocks pain	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Infections and infestations Catheter-related infection	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Psychiatric disorders Confusion	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Gastrointestinal disorders Constipation	23.8% 5/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Respiratory, thoracic and mediastinal disorders Cough	28.6% 6/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Skin and subcutaneous tissue disorders Decubitus ulcer - sacral	9.5% 2/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Metabolism and nutrition disorders Dehydration	14.3% 3/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
General disorders Diaphoresis	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Gastrointestinal disorders Diarrhea	38.1% 8/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Gastrointestinal disorders Distension	19.0% 4/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Nervous system disorders Dizziness/lightheadedness	23.8% 5/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Gastrointestinal disorders Dry mouth	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Gastrointestinal disorders Dysgeusia	9.5% 2/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Gastrointestinal disorders Dyspepsia/heartburn	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Respiratory, thoracic and mediastinal disorders Dyspnea	28.6% 6/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Ear and labyrinth disorders Ears "clogged"	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Ear and labyrinth disorders Ears "popping"	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
General disorders Edema - limbs	33.3% 7/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Investigations Elevated creatinine	14.3% 3/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Ear and labyrinth disorders External ear pain	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Eye disorders Eye bleed	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Musculoskeletal and connective tissue disorders Face/brow pain	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Skin and subcutaneous tissue disorders Facial bumps	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
General disorders Fatigue	57.1% 12/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
General disorders Fever	38.1% 8/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Gastrointestinal disorders Flatulence	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Musculoskeletal and connective tissue disorders Foot pain	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Gastrointestinal disorders Gastric irritation	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Gastrointestinal disorders Gastritis	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
General disorders Generalized pain	19.0% 4/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Gastrointestinal disorders Gritty sensation in mouth	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Endocrine disorders Gynecomastia	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Nervous system disorders Head pressure	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Nervous system disorders Headache	28.6% 6/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Musculoskeletal and connective tissue disorders Heel pain	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Blood and lymphatic system disorders Hemoglobin	52.4% 11/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Musculoskeletal and connective tissue disorders Hip pain	9.5% 2/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Vascular disorders Hot flashes	14.3% 3/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Investigations Hypercalcemia	9.5% 2/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Investigations Hyperglycemia	14.3% 3/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Investigations Hypermagnesemia	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Skin and subcutaneous tissue disorders Hyperpigmentation	9.5% 2/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Cardiac disorders Hypertension	9.5% 2/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Blood and lymphatic system disorders Hypervolemia	14.3% 3/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Investigations Hypoalbuminemia	19.0% 4/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Investigations Hypocalcemia	9.5% 2/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Investigations Hypoglycemia	14.3% 3/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Investigations Hypokalemia	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Investigations Hypomagnesemia	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Investigations Hyponatremia	23.8% 5/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Cardiac disorders Hypotension	9.5% 2/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Respiratory, thoracic and mediastinal disorders Hypoxia	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Renal and urinary disorders Incontinence	9.5% 2/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Infections and infestations Infection without neutropenia	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Cardiac disorders Left ventricular systolic dysfunction	9.5% 2/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Investigations Leukocytes	23.8% 5/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Gastrointestinal disorders Lower GI bleed	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Musculoskeletal and connective tissue disorders Lower extremity pain	14.3% 3/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Blood and lymphatic system disorders Lymphocele (cyst on face)	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Investigations Lymphopenia	52.4% 11/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Psychiatric disorders Mood alteration - anxiety	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Gastrointestinal disorders Mucositis	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Gastrointestinal disorders Nausea	28.6% 6/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Nervous system disorders Neuropathy - motor	14.3% 3/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Nervous system disorders Neuropathy - sensory	14.3% 3/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Investigations Neutrophils	19.0% 4/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
General disorders Night sweats	9.5% 2/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Musculoskeletal and connective tissue disorders Nipple pain	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Respiratory, thoracic and mediastinal disorders Nose bleed	9.5% 2/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
General disorders Odor (patient odor)	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Skin and subcutaneous tissue disorders Oily face	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Gastrointestinal disorders Oral/gum/teeth pain	9.5% 2/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Blood and lymphatic system disorders Petechiae	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Skin and subcutaneous tissue disorders Photosensitivity	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Investigations Platelets	42.9% 9/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Respiratory, thoracic and mediastinal disorders Pleural effusion	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Infections and infestations Pneumonia	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	9.5% 2/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Renal and urinary disorders Proteinuria	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Respiratory, thoracic and mediastinal disorders Pulmonary edema	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Skin and subcutaneous tissue disorders Rash	28.6% 6/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Renal and urinary disorders Renal failure	9.5% 2/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
General disorders Right side of nose swollen	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
General disorders Rigors	14.3% 3/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Respiratory, thoracic and mediastinal disorders Runny nose	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Investigations SGOT (AST)	23.8% 5/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Investigations SGPT (ALT)	14.3% 3/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Gastrointestinal disorders Sensitive teeth	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Infections and infestations Sepsis	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Musculoskeletal and connective tissue disorders Shoulder pain	9.5% 2/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Respiratory, thoracic and mediastinal disorders Sinus discharge	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Infections and infestations Sinus infection	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Injury, poisoning and procedural complications Skin tears	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Nervous system disorders Somnolence	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Gastrointestinal disorders Stomach tightness	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Cardiac disorders Tachycardia	9.5% 2/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Musculoskeletal and connective tissue disorders Thigh pain	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Gastrointestinal disorders Tongue felt "thick"	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Gastrointestinal disorders Under tongue felt swollen	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Musculoskeletal and connective tissue disorders Upper extremity pain	9.5% 2/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Respiratory, thoracic and mediastinal disorders Upper respiratory congestion	9.5% 2/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Investigations Uric acid	4.8% 1/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)
Gastrointestinal disorders Vomiting	23.8% 5/21 • Adverse events were collected from the start of treatment until 30 days following the completion of treatment (median duration of therapy was 51 days)

Additional Information

Ravi Vij, M.D.

Washington University School of Medicine

Phone: 314-454-8304

Email: rvij@dom.wustl.edu

Results disclosure agreements

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