Trial Outcomes & Findings for Study of the Pan-DAC Inhibitor AR-42 and Pazopanib in Advanced Sarcoma and Kidney Cancer (NCT NCT02795819)

Last Updated: 2019-10-24

Results Overview

To determine the recommended phase 2 doses (RP2Ds) for AR-42 and pazopanib that are the same as or less than the maximum tolerated doses (MTDs). The dose-limiting toxicity (DLT) evaluation period will be the first treatment cycle. Patients must have taken a minimum of 6 AR-42 doses and a minimum of 21 pazopanib doses during cycle 1 to be considered evaluable for DLT, if DLT has not been observed at the delivered dose. Patients' treatment dose level, dose modification, evaluability for DLT, and DLTs will be listed and summarized by basic descriptive statistics such as frequency and proportion. The maximum tolerated dose(MTDs)/recommended phase 2 doses (RP2Ds) will be found based on the criteria in the protocol.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

6 participants

Primary outcome timeframe

1 month

Results posted on

2019-10-24

Participant Flow

Subjects were recruited from a single academic medical center cancer clinic from July 8, 2016 through November 22, 2016.

Participant milestones

Participant milestones
Measure	Cohort Minus 1 (-1) Participants take 10 mg AR-42 orally per day on 3 non-consecutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously	Cohort 1 Participants take 20 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously	Cohort 2 Participants take 20 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 800mg orally daily continuously	Cohort 3A Participants take 30 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 800mg orally daily continuously	Cohort 3B Participants take 30 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously	Cohort 4A Participants take 40 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 800mg orally daily continuously	Cohort 4B Participants take 40 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously
Overall Study STARTED	0	6	0	0	0	0	0
Overall Study COMPLETED	0	6	0	0	0	0	0
Overall Study NOT COMPLETED	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of the Pan-DAC Inhibitor AR-42 and Pazopanib in Advanced Sarcoma and Kidney Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=6 Participants Participants take 20 mg AR-42 orally per day on 3 non-consecutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	54.8 Years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Population: Incomplete objective. No maximum tolerated dose (MTD) nor recommended phase two dose (RP2D) identified. Two dose limiting toxicities observed in 6 patients treated at the first dose level. Study terminated prior to exploration of additional dose levels.

Outcome measures

Outcome measures
Measure	Cohort Minus 1 (-1) Participants take 10 mg AR-42 orally per day on 3 non-consecutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously	Cohort 1 n=2 Dose Limiting Toxicities Participants take 20 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously	Cohort 2 Participants take 20 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 800mg orally daily continuously	Cohort 3A Participants take 30 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 800mg orally daily continuously	Cohort 3B Participants take 30 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously	Cohort 4A Participants take 40 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 800mg orally daily continuously	Cohort 4B Participants take 40 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously
The Recommended Phase 2 Doses (RP2Ds) of AR-42 and Pazopanib When Given in Combination.	0 Dose Limiting Toxicities	2 Dose Limiting Toxicities	0 Dose Limiting Toxicities	0 Dose Limiting Toxicities	0 Dose Limiting Toxicities	0 Dose Limiting Toxicities	0 Dose Limiting Toxicities

SECONDARY outcome

Timeframe: 5 months

The safety and toxicity of AR-42 and pazopanib when given in combination. Adverse Events (AEs) were characterized and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0) to determine the safety and toxicity of the combination of AR-42 and pazopanib. All AEs regardless of grade were recorded from the beginning of the study procedures through 30 days following the end of study treatment.

Outcome measures

Outcome measures
Measure	Cohort Minus 1 (-1) Participants take 10 mg AR-42 orally per day on 3 non-consecutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously	Cohort 1 n=6 Participants Participants take 20 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously	Cohort 2 Participants take 20 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 800mg orally daily continuously	Cohort 3A Participants take 30 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 800mg orally daily continuously	Cohort 3B Participants take 30 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously	Cohort 4A Participants take 40 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 800mg orally daily continuously	Cohort 4B Participants take 40 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously
Number of Participants With Adverse Events That Were Related to Treatment, AR-42 and Pazopanib Combination.	0 Participants	6 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 5 months

Population: Of 6 patients treated at dose level 1, 4 were evaluable for response.

Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Outcome measures

Outcome measures
Measure	Cohort Minus 1 (-1) Participants take 10 mg AR-42 orally per day on 3 non-consecutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously	Cohort 1 n=4 Participants Participants take 20 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously	Cohort 2 Participants take 20 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 800mg orally daily continuously	Cohort 3A Participants take 30 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 800mg orally daily continuously	Cohort 3B Participants take 30 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously	Cohort 4A Participants take 40 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 800mg orally daily continuously	Cohort 4B Participants take 40 mg AR-42 orally per day on 3 non-consectutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously
The Antitumor Effects of the AR-42 and Pazopanib Treatment Regimen in Patients With Advanced Renal Cell Carcinoma (RCC) or Soft Tissue Sarcoma (STS). Partial Response	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
The Antitumor Effects of the AR-42 and Pazopanib Treatment Regimen in Patients With Advanced Renal Cell Carcinoma (RCC) or Soft Tissue Sarcoma (STS). Stable Disease	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
The Antitumor Effects of the AR-42 and Pazopanib Treatment Regimen in Patients With Advanced Renal Cell Carcinoma (RCC) or Soft Tissue Sarcoma (STS). Progression	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Cohort 1

Serious events: 2 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1 n=6 participants at risk Participants take 20 mg AR-42 orally per day on 3 non-consecutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously.
Blood and lymphatic system disorders Anemia	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Blood and lymphatic system disorders Disseminated Intravascular Coagulation	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Cardiac disorders Cardiac Arrest	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Cardiac disorders Sinus Tachycardia	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Cardiac disorders Ventricular Tachycardia	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Gastrointestinal disorders Abdominal Pain	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Gastrointestinal disorders Mucositis Oral	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Gastrointestinal disorders Nausea	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
General disorders Fatigue	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
General disorders General Disorders administration site conditions - Other, specify	16.7% 1/6 • Number of events 2 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
General disorders Multi Organ Failure	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Infections and infestations Sepsis	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Infections and infestations Upper Respiratory Infection	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Infections and infestations Urinary Tract Infection	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Investigations Alanine aminotransferase increased	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Investigations Creatinine increased	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Investigations Fibrinogen decreased	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Investigations Urine output decreased	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Metabolism and nutrition disorders Anorexia	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Metabolism and nutrition disorders Dehydration	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Metabolism and nutrition disorders Hypoalbuminemia	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Metabolism and nutrition disorders Hypoglycemia	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Musculoskeletal and connective tissue disorders Arthritis	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Nervous system disorders Encephalopathy	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Nervous system disorders Nervous system disorders - Other, specify	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Nervous system disorders Seizure	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Psychiatric disorders Agitation	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Psychiatric disorders Anxiety	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Psychiatric disorders Delirium	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Renal and urinary disorders Acute kidney injury	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Renal and urinary disorders Proteinuria	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Respiratory, thoracic and mediastinal disorders Aspiration	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Respiratory, thoracic and mediastinal disorders Hypoxia	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Respiratory, thoracic and mediastinal disorders Pleural effusion	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Respiratory, thoracic and mediastinal disorders Respiratory failure	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Vascular disorders Hypotension	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.

Other adverse events

Other adverse events
Measure	Cohort 1 n=6 participants at risk Participants take 20 mg AR-42 orally per day on 3 non-consecutive days during the 1st 3 weeks of each 4-week cycle and pazopanib 600mg orally daily continuously.
Blood and lymphatic system disorders Anemia	50.0% 3/6 • Number of events 4 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Blood and lymphatic system disorders Lymph node pain	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Cardiac disorders Cardiac disorders - Other, specify	16.7% 1/6 • Number of events 3 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Cardiac disorders Sinus bradycardia	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Cardiac disorders Sinus tachycardia	50.0% 3/6 • Number of events 6 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Eye disorders Dry eye	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Eye disorders Eye pain	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Eye disorders Photophobia	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Gastrointestinal disorders Abdominal pain	66.7% 4/6 • Number of events 8 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Gastrointestinal disorders Bloating	66.7% 4/6 • Number of events 4 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Gastrointestinal disorders Constipation	16.7% 1/6 • Number of events 2 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Gastrointestinal disorders Diarrhea	33.3% 2/6 • Number of events 3 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Gastrointestinal disorders Dry mouth	50.0% 3/6 • Number of events 3 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Gastrointestinal disorders Flatulence	33.3% 2/6 • Number of events 2 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Gastrointestinal disorders Gastroesophageal reflux disease	33.3% 2/6 • Number of events 2 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Gastrointestinal disorders Gastrointestinal pain	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Gastrointestinal disorders Gastroparesis	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Gastrointestinal disorders Ileus	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Gastrointestinal disorders Mucositis oral	50.0% 3/6 • Number of events 4 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Gastrointestinal disorders Small intestinal obstruction	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Gastrointestinal disorders Vomiting	50.0% 3/6 • Number of events 5 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
General disorders Chills	33.3% 2/6 • Number of events 2 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
General disorders Edema limbs	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
General disorders Fatigue	50.0% 3/6 • Number of events 3 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
General disorders Fever	50.0% 3/6 • Number of events 3 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
General disorders General disorders and administration site conditions - Other, specify	33.3% 2/6 • Number of events 2 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
General disorders Malaise	66.7% 4/6 • Number of events 9 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
General disorders Non-cardiac chest pain	16.7% 1/6 • Number of events 2 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
General disorders Pain	66.7% 4/6 • Number of events 5 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Infections and infestations Infections and infestations - Other, specify	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Infections and infestations Lung infection	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Infections and infestations Urinary tract infection	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Injury, poisoning and procedural complications Bruising	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Injury, poisoning and procedural complications Vascular access complication	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Investigations Activated partial thromboplastin time prolonged	33.3% 2/6 • Number of events 2 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Investigations Alanine aminotransferase increased	66.7% 4/6 • Number of events 6 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Investigations Alkaline phosphatase increased	50.0% 3/6 • Number of events 4 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Investigations Aspartate aminotransferase increased	50.0% 3/6 • Number of events 5 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Investigations Blood bilirubin increased	33.3% 2/6 • Number of events 4 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Investigations Creatinine increased	33.3% 2/6 • Number of events 3 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Investigations Electrocardiogram QT corrected interval prolonged	33.3% 2/6 • Number of events 2 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Investigations Investigations - Other, specify	33.3% 2/6 • Number of events 3 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Investigations Lipase increased	33.3% 2/6 • Number of events 5 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Investigations Lymphocyte count decreased	100.0% 6/6 • Number of events 14 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Investigations Neutrophil count decreased	83.3% 5/6 • Number of events 7 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Investigations Platelet count decreased	66.7% 4/6 • Number of events 9 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Investigations Serum amylase increased	16.7% 1/6 • Number of events 4 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Investigations Weight loss	50.0% 3/6 • Number of events 4 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Investigations White blood cell decreased	83.3% 5/6 • Number of events 10 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Metabolism and nutrition disorders Anorexia	83.3% 5/6 • Number of events 8 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Metabolism and nutrition disorders Dehydration	33.3% 2/6 • Number of events 3 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Metabolism and nutrition disorders Hyperglycemia	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Metabolism and nutrition disorders Hyperkalemia	33.3% 2/6 • Number of events 2 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Metabolism and nutrition disorders Hypermagnesemia	50.0% 3/6 • Number of events 3 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Metabolism and nutrition disorders Hypernatremia	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Metabolism and nutrition disorders Hypoalbuminemia	33.3% 2/6 • Number of events 3 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Metabolism and nutrition disorders Hypocalcemia	50.0% 3/6 • Number of events 4 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Metabolism and nutrition disorders Hypokalemia	50.0% 3/6 • Number of events 4 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Metabolism and nutrition disorders Hypomagnesemia	33.3% 2/6 • Number of events 2 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Metabolism and nutrition disorders Hyponatremia	50.0% 3/6 • Number of events 8 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Metabolism and nutrition disorders Hypophosphatemia	33.3% 2/6 • Number of events 4 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Metabolism and nutrition disorders Nausea	83.3% 5/6 • Number of events 6 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Musculoskeletal and connective tissue disorders Arthralgia	50.0% 3/6 • Number of events 6 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Musculoskeletal and connective tissue disorders Bone pain	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Musculoskeletal and connective tissue disorders Flank pain	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	16.7% 1/6 • Number of events 2 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	66.7% 4/6 • Number of events 5 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Musculoskeletal and connective tissue disorders Myalgia	33.3% 2/6 • Number of events 3 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Musculoskeletal and connective tissue disorders Pain in extremity	33.3% 2/6 • Number of events 5 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Nervous system disorders Dizziness	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Nervous system disorders Dysgeusia	33.3% 2/6 • Number of events 3 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Nervous system disorders Headache	66.7% 4/6 • Number of events 4 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Nervous system disorders Memory impairment	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Nervous system disorders Peripheral sensory neuropathy	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Nervous system disorders Sinus pain	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Nervous system disorders Somnolence	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Psychiatric disorders Anxiety	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Psychiatric disorders Hallucinations	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Psychiatric disorders Insomnia	50.0% 3/6 • Number of events 3 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Renal and urinary disorders Hematuria	50.0% 3/6 • Number of events 4 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Renal and urinary disorders Proteinuria	50.0% 3/6 • Number of events 3 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Renal and urinary disorders Urinary frequency	33.3% 2/6 • Number of events 2 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Renal and urinary disorders Urinary incontinence	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Renal and urinary disorders Urinary tract pain	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Renal and urinary disorders Urinary urgency	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Reproductive system and breast disorders Pelvic pain	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 2/6 • Number of events 4 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 2/6 • Number of events 2 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Respiratory, thoracic and mediastinal disorders Epistaxis	33.3% 2/6 • Number of events 2 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Respiratory, thoracic and mediastinal disorders Hoarseness	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Respiratory, thoracic and mediastinal disorders Nasal congestion	33.3% 2/6 • Number of events 2 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Respiratory, thoracic and mediastinal disorders Pleural effusion	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Respiratory, thoracic and mediastinal disorders Productive cough	33.3% 2/6 • Number of events 2 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	33.3% 2/6 • Number of events 2 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Respiratory, thoracic and mediastinal disorders Sore throat	33.3% 2/6 • Number of events 3 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Respiratory, thoracic and mediastinal disorders Voice alteration	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Skin and subcutaneous tissue disorders Pruritus	16.7% 1/6 • Number of events 2 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	50.0% 3/6 • Number of events 4 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Skin and subcutaneous tissue disorders Skin hypopigmentation	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Vascular disorders Hypertension	50.0% 3/6 • Number of events 3 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.
Vascular disorders Hypotension	16.7% 1/6 • Number of events 1 • Adverse event data was collected from Cycle 1 Day 1 to Off-Study Visit for each patient. All trial patients were enrolled on Cohort 1.

Additional Information

Andrew Poklepovic, MD

Virginia Commonwealth University Massey Cancer Center

Phone: 877-462-7739

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place