Trial Outcomes & Findings for Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma (NCT NCT00865969)

Last Updated: 2021-10-29

Results Overview

Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR) according to International Working Group (IWG) criteria. The response was assessed based on clinical and radiological criteria. CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites. As pre-defined, the primary endpoint analysis for this study was based on the Independent Review Committee (IRC) assessment of response.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

129 participants

Primary outcome timeframe

24 months

Results posted on

2021-10-29

Participant Flow

Participants with relapsed or refractory T-Cell lymphoma who signed the informed consent form and met all Inclusion/Exclusion criteria were enrolled in the study.

Participant milestones

Participant milestones
Measure	Belinostat Belinostat 1000mg/m\^2 administered as a 30 minute IV infusion from Days 1-5 of a 3-week cycle until disease progression or unmanageable treatment-related toxicities.
Overall Study STARTED	129
Overall Study COMPLETED	129
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Belinostat n=129 Participants Belinostat 1000 mg/m\^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities.
Age, Continuous	63 years n=93 Participants
Sex: Female, Male Female	60 Participants n=93 Participants
Sex: Female, Male Male	69 Participants n=93 Participants

PRIMARY outcome

Timeframe: 24 months

Population: Efficacy Analysis Dataset included participants who received at least 1 dose of belinostat and had a confirmed peripheral T-cell lymphoma (PTCL) diagnosis.

Outcome measures

Outcome measures
Measure	Belinostat n=120 Participants Belinostat 1000 mg/m\^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities.
Objective Response Rate	25.8 percentage of participants Interval 18.3 to 34.6

SECONDARY outcome

Timeframe: 24 months

Population: Efficacy Analysis Dataset included participants who received at least 1 dose of belinostat and had a confirmed PTCL diagnosis. Overall number of participants analyzed included responding participants (CR/PR) only.

Time to response was defined as the time (in weeks) from first administration of treatment until first response. Response is defined as complete response (CR) or partial response (PR). CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites.

Outcome measures

Outcome measures
Measure	Belinostat n=31 Participants Belinostat 1000 mg/m\^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities.
Time to Response	5.6 weeks Interval 4.3 to 50.4

SECONDARY outcome

Timeframe: 24 months

The Duration of Response was assessed by IWG criteria per the IRC from the date the measurement criteria were first met for CR or PR (whichever status was recorded first) until the first subsequent date that relapse or progression was documented. It was estimated by the Kaplan-Meier method. Response is defined as complete response (CR) or partial response (PR). CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites.

Outcome measures

Outcome measures
Measure	Belinostat n=31 Participants Belinostat 1000 mg/m\^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities.
Duration of Response	13.6 months Interval 4.5 to 29.4

SECONDARY outcome

Timeframe: 24 months

Population: Efficacy Analysis Dataset included participants who received at least 1 dose of belinostat and had a confirmed PTCL diagnosis.

Time to progression was defined as the time (in months) from first administration of treatment to the date of disease progression based on tumor assessments made according to the IWG criteria as assessed by the IRC. The progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.

Outcome measures

Outcome measures
Measure	Belinostat n=120 Participants Belinostat 1000 mg/m\^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities.
Time to Progression	2 months Interval 1.5 to 2.9

SECONDARY outcome

Timeframe: 24 months

Population: Efficacy Analysis Dataset included participants who received at least 1 dose of belinostat and had a confirmed PTCL diagnosis.

Progression-free survival (PFS) was the duration of time from first administration of study treatment to date of first documented progression or death from any cause. It was based on tumor assessments made according to the IWG criteria as assessed by the IRC. The progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.

Outcome measures

Outcome measures
Measure	Belinostat n=120 Participants Belinostat 1000 mg/m\^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities.
Progression Free Survival	1.6 months Interval 1.4 to 2.7

SECONDARY outcome

Timeframe: 24 months

Population: Efficacy Analysis Dataset included participants who received at least 1 dose of belinostat and had a confirmed PTCL diagnosis.

Overall Survival was the time from first administration of study treatment until the date of death.

Outcome measures

Outcome measures
Measure	Belinostat n=120 Participants Belinostat 1000 mg/m\^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities.
Overall Survival	7.9 months Interval 6.1 to 13.9

SECONDARY outcome

Timeframe: 24 months

Population: Full Analysis Dataset included all participants who received at least 1 dose of belinostat.

A TEAE was defined as an event with an onset date and time on or after the first dosing start date and time, or on or after the first dosing start date if the onset time was missing. A serious TEAE was any untoward medical occurrence that at any dose results in death, prolonged hospitalization, persistent or significant disability or congenital abnormalities.

Outcome measures

Outcome measures
Measure	Belinostat n=129 Participants Belinostat 1000 mg/m\^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities.
Number of Participants With At Least One Serious Treatment-Emergent Adverse Event (TEAE)	61 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Outcome measures

Outcome data not reported

Adverse Events

Belinostat

Serious events: 61 serious events

Other events: 125 other events

Deaths: 22 deaths

Serious adverse events

Serious adverse events
Measure	Belinostat n=129 participants at risk Belinostat 1000 mg/m\^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities.
Infections and infestations Pneumonia	7.8% 10/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
General disorders Pyrexia	4.7% 6/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Infections and infestations Infection	3.1% 4/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Blood and lymphatic system disorders Anaemia	2.3% 3/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Investigations Blood creatinine increased	2.3% 3/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
General disorders Multi-organ disorder	2.3% 3/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Blood and lymphatic system disorders Thrombocytopenia	2.3% 3/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Infections and infestations Bronchitis	2.3% 3/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Cardiac disorders Cardiac failure	1.6% 2/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Vascular disorders Deep vein thrombosis	2.3% 3/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
General disorders Fatigue	1.6% 2/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Blood and lymphatic system disorders Febrile neutropenia	1.6% 2/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Vascular disorders Hypotension	1.6% 2/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.3% 3/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Infections and infestations Sepsis	1.6% 2/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Metabolism and nutrition disorders Tumour lysis syndrome	1.6% 2/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Skin and subcutaneous tissue disorders Actinic keratosis	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Investigations Alanine aminotransferase increased	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Respiratory, thoracic and mediastinal disorders Alveolitis	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Blood and lymphatic system disorders Anaemia haemolytic autoimmune	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Psychiatric disorders Anxiety	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Musculoskeletal and connective tissue disorders Arthralgia	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Investigations Aspartate aminotransferase increased	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
General disorders Asthenia	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Cardiac disorders Atrial fibrillation	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Infections and infestations Bronchitis bacterial	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Surgical and medical procedures Central venous catheterisation	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Respiratory, thoracic and mediastinal disorders Chylothorax	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Gastrointestinal disorders Constipation	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Metabolism and nutrition disorders Decreased appetite	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Infections and infestations Device related infection	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Infections and infestations Endocarditis	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
General disorders Euthanasia	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Vascular disorders Extremity necrosis	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Investigations Gamma-glutamyltransferase increased	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Infections and infestations Gastrointestinal fungal infection	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
General disorders General physical health deterioration	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Blood and lymphatic system disorders Haemolytic anaemia	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Hepatobiliary disorders Hepatic failure	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Hepatobiliary disorders Hyperbilirubinaemia	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Metabolism and nutrition disorders Hypercalcaemia	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Metabolism and nutrition disorders Hyperglycaemia	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Metabolism and nutrition disorders Hypoglycaemia	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Vascular disorders Iliac artery occlusion	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Psychiatric disorders Impaired self-care	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Investigations Liver function test abnormal	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Injury, poisoning and procedural complications Lower limb fracture	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Infections and infestations Lung infection	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
General disorders Malaise	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Injury, poisoning and procedural complications Multiple fractures	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
General disorders Pain	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Skin and subcutaneous tissue disorders Pain of skin	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Blood and lymphatic system disorders Pancytopenia	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Musculoskeletal and connective tissue disorders Pathological fracture	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Nervous system disorders Peripheral sensory neuropathy	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Infections and infestations Pharyngitis	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Investigations Platelet count decreased	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Skin and subcutaneous tissue disorders Rash	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Renal and urinary disorders Renal failure	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Infections and infestations Septic shock	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Vascular disorders Shock	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Blood and lymphatic system disorders Splenomegaly	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Eye disorders Toxic cataract	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Infections and infestations Upper respiratory tract infection	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Infections and infestations Urosepsis	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Vascular disorders Vasculitis	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Vascular disorders Venous thrombosis limb	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
General disorders Chills	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
General disorders Disease progression	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Metabolism and nutrition disorders Dehydration	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Infections and infestations Bronchopneumopathy	0.78% 1/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.

Other adverse events

Other adverse events
Measure	Belinostat n=129 participants at risk Belinostat 1000 mg/m\^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities.
Gastrointestinal disorders Nausea	42.6% 55/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
General disorders Fatigue	36.4% 47/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
General disorders Pyrexia	34.9% 45/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Blood and lymphatic system disorders Anemia	31.8% 41/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Gastrointestinal disorders Vomiting	28.7% 37/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Gastrointestinal disorders Constipation	22.5% 29/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Gastrointestinal disorders Diarrhea	21.7% 28/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Respiratory, thoracic and mediastinal disorders Dyspnea	22.5% 29/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
General disorders Edema Peripheral	20.9% 27/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Skin and subcutaneous tissue disorders Rash	20.2% 26/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Respiratory, thoracic and mediastinal disorders Cough	19.4% 25/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
General disorders Chills	16.3% 21/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Blood and lymphatic system disorders Thrombocytopenia	16.3% 21/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Skin and subcutaneous tissue disorders Pruritus	16.3% 21/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Investigations Blood Lactate Dehydrogenase Increased	15.5% 20/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Metabolism and nutrition disorders Decreased appetite	14.7% 19/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Nervous system disorders Headache	14.7% 19/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
General disorders Infusion Site Pain	14.0% 18/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Metabolism and nutrition disorders Hypokalemia	13.2% 17/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Gastrointestinal disorders Abdominal Pain	10.9% 14/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Investigations Electrocardiogram QT Prolonged	11.6% 15/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Vascular disorders Hypotension	10.1% 13/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Vascular disorders Phlebitis	9.3% 12/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Nervous system disorders Dizziness	10.1% 13/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
General disorders Asthenia	9.3% 12/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
General disorders Pain	9.3% 12/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Blood and lymphatic system disorders Leukopenia	10.1% 13/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Blood and lymphatic system disorders Neutropenia	10.1% 13/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Metabolism and nutrition disorders Hyperglycemia	9.3% 12/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Infections and infestations Bronchitis	7.0% 9/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Blood and lymphatic system disorders Lymphopenia	8.5% 11/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Musculoskeletal and connective tissue disorders Pain In Extremity	8.5% 11/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Infections and infestations Upper Respiratory Tract Infection	7.8% 10/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Metabolism and nutrition disorders Hypoalbuminemia	7.8% 10/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Nervous system disorders Neuropathy Peripheral	7.0% 9/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Investigations Aspartate Aminotransferase Increased	8.5% 11/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Investigations Blood Creatinine Increased	6.2% 8/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Investigations Platelet Count Decreased	6.2% 8/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Vascular disorders Flushing	7.0% 9/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Musculoskeletal and connective tissue disorders Muscle Spasms	7.0% 9/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Psychiatric disorders Insomnia	7.0% 9/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Investigations Alanine Aminotransferase Increased	7.0% 9/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Metabolism and nutrition disorders Hyperuricemia	6.2% 8/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	6.2% 8/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Skin and subcutaneous tissue disorders Night sweats	6.2% 8/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Psychiatric disorders Anxiety	5.4% 7/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Gastrointestinal disorders Abdominal Pain Upper	5.4% 7/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Infections and infestations Nasopharyngitis	5.4% 7/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Infections and infestations Sinusitis	5.4% 7/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Investigations Blood Alkaline Phosphatase Increased	5.4% 7/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Investigations Weight Decreased	6.2% 8/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Metabolism and nutrition disorders Hypomagnesemia	7.0% 9/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Skin and subcutaneous tissue disorders Hyperhidrosis	5.4% 7/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.
Vascular disorders Hypertension	5.4% 7/129 • Up to 25 months Participants were carefully monitored for all adverse events that occurred from the time Informed Consent was obtained until 30 days after the last study drug administration.

Additional Information

Gajanan Bhat, PhD

Spectrum Pharmaceuticals

Phone: 949-743-9219

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place