Trial Outcomes & Findings for Cediranib Maleate and Combination Chemotherapy in Treating Patients With Advanced Biliary Cancers (NCT NCT01229111)

Last Updated: 2017-03-29

Results Overview

The number of patients with a Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of the 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 progressions); 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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Up to 3 years

Results posted on

2017-03-29

Participant Flow

Patients were recruited from hospitals in Cleveland and Columbus, Ohio from October 2010 through February 2013.

Participant milestones

Participant milestones
Measure	Treatment (Cediranib Maleate and Modified FOLFOX) Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1. cediranib maleate: Given PO oxaliplatin: Given IV leucovorin calcium: Given IV fluorouracil: Given IV
Overall Study STARTED	14
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Cediranib Maleate and Modified FOLFOX) Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1. cediranib maleate: Given PO oxaliplatin: Given IV leucovorin calcium: Given IV fluorouracil: Given IV
Overall Study Death	1

Baseline Characteristics

Cediranib Maleate and Combination Chemotherapy in Treating Patients With Advanced Biliary Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Cediranib Maleate and Modified FOLFOX) n=14 Participants Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1. cediranib maleate: Given PO oxaliplatin: Given IV leucovorin calcium: Given IV fluorouracil: Given IV
Age, Customized 30-39 years	1 participants n=5 Participants
Age, Customized 40-49 years	1 participants n=5 Participants
Age, Customized 50-59 years	3 participants n=5 Participants
Age, Customized 60-69 years	8 participants n=5 Participants
Age, Customized 70-79 years	1 participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 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	1 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	2 Participants n=5 Participants
Race (NIH/OMB) White	11 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	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Population: Patients that were evaluable

Outcome measures

Outcome measures
Measure	Treatment (Cediranib Maleate and Modified FOLFOX) n=11 Participants Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1. cediranib maleate: Given PO oxaliplatin: Given IV leucovorin calcium: Given IV fluorouracil: Given IV
The Response Rate of Patients Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Partial Response (PR)	4 participants
The Response Rate of Patients Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Stable Disease (SD)	6 participants
The Response Rate of Patients Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Progressive Disease (PD)	1 participants

SECONDARY outcome

Timeframe: Up to 3 years

Population: All patients that received treatment drug

Number of patients that experienced \>/= grade 3 treatment related toxicities (definite, probable, possible).

Outcome measures

Outcome measures
Measure	Treatment (Cediranib Maleate and Modified FOLFOX) n=13 Participants Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1. cediranib maleate: Given PO oxaliplatin: Given IV leucovorin calcium: Given IV fluorouracil: Given IV
Tabulation of the Toxicity Profile of the Combination Therapy	11 participants

SECONDARY outcome

Timeframe: Up to 3 years

Population: Patients that were evaluable for response

Time in months that evaluable subjects survived progression free

Outcome measures

Outcome measures
Measure	Treatment (Cediranib Maleate and Modified FOLFOX) n=13 Participants Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1. cediranib maleate: Given PO oxaliplatin: Given IV leucovorin calcium: Given IV fluorouracil: Given IV
Progression Free Survival	14.4 Months Interval 3.0 to 22.5

SECONDARY outcome

Timeframe: Up to 3 years

Population: Patients that received treatment.

Time of overall response

Outcome measures

Outcome measures
Measure	Treatment (Cediranib Maleate and Modified FOLFOX) n=13 Participants Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1. cediranib maleate: Given PO oxaliplatin: Given IV leucovorin calcium: Given IV fluorouracil: Given IV
Estimation of Overall Survival	19.2 Months Interval 3.0 to 31.3

SECONDARY outcome

Timeframe: Up to three years

Population: Statistically, due to the small sample size, analysis could not be done

Factors that predict survival will be identified by Cox model or extended Cox model.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Cediranib Maleate and Modified FOLFOX)

Serious events: 11 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Cediranib Maleate and Modified FOLFOX) n=13 participants at risk Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1. cediranib maleate: Given PO oxaliplatin: Given IV leucovorin calcium: Given IV fluorouracil: Given IV
Blood and lymphatic system disorders Anemia	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Gastrointestinal disorders Abdominal Pain	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Gastrointestinal disorders Ascites	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Gastrointestinal disorders Colitis	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Gastrointestinal disorders Diarrhea	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Gastrointestinal disorders Duodenal hemorrage	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Gastrointestinal disorders Duodenal ulcer	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Gastrointestinal disorders Duodenal Obstruction	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Gastrointestinal disorders Nausea	15.4% 2/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Gastrointestinal disorders Vomiting	15.4% 2/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
General disorders Death	15.4% 2/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
General disorders Fatigue	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Infections and infestations Biliary Tract infection	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Injury, poisoning and procedural complications Catheter related infection	15.4% 2/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Infections and infestations Skin Infection	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Renal and urinary disorders Urinary tract infection	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Injury, poisoning and procedural complications Fall	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Injury, poisoning and procedural complications Vascular access complication	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Investigations Neutrophil count decreased	23.1% 3/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Investigations Platelet count decreased	15.4% 2/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Metabolism and nutrition disorders Hypocalcemia	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Metabolism and nutrition disorders Hypokalemia	23.1% 3/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	15.4% 2/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Nervous system disorders Altered mental status	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Pregnancy, puerperium and perinatal conditions Confusion	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Renal and urinary disorders Acute kidney injury	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Gastrointestinal disorders Abscess	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Blood and lymphatic system disorders Fibrile Neutropenia	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Infections and infestations Lung Infection	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.

Other adverse events

Other adverse events
Measure	Treatment (Cediranib Maleate and Modified FOLFOX) n=13 participants at risk Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1. cediranib maleate: Given PO oxaliplatin: Given IV leucovorin calcium: Given IV fluorouracil: Given IV
Gastrointestinal disorders Abdominal distension	15.4% 2/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Gastrointestinal disorders Abdominal pain	84.6% 11/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Investigations Alanine aminotransferase increased	69.2% 9/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Investigations Alkaline phosphatase increased	100.0% 13/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Immune system disorders Allergic reaction	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Skin and subcutaneous tissue disorders Alopecia	46.2% 6/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Gastrointestinal disorders Anal hemorrhage	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Blood and lymphatic system disorders Anemia	69.2% 9/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Metabolism and nutrition disorders Anorexia	84.6% 11/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Psychiatric disorders Anxiety	46.2% 6/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Cardiac disorders Aortic valve disease	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Musculoskeletal and connective tissue disorders Arthralgia	15.4% 2/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Investigations Aspartate aminotransferase increased	76.9% 10/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Cardiac disorders Atrial fibrillation	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Musculoskeletal and connective tissue disorders Back pain	38.5% 5/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Infections and infestations Biliary tract infection	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Investigations Blood bilirubin increased	38.5% 5/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Eye disorders Blurred vision	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Musculoskeletal and connective tissue disorders Bone pain	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Injury, poisoning and procedural complications Bruising	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Cardiac disorders Catheter related infection	15.4% 2/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Psychiatric disorders Chest pain - cardiac	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Gastrointestinal disorders Confusion	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Respiratory, thoracic and mediastinal disorders Constipation	61.5% 8/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Investigations Cough	15.4% 2/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Metabolism and nutrition disorders Creatinine increased	15.4% 2/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Psychiatric disorders Dehydration	23.1% 3/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Gastrointestinal disorders Depression	30.8% 4/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Nervous system disorders Diarrhea	61.5% 8/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Gastrointestinal disorders Dizziness	61.5% 8/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Skin and subcutaneous tissue disorders Dry mouth	15.4% 2/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Gastrointestinal disorders Duodenal ulcer	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Nervous system disorders Dysarthria	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Nervous system disorders Dysgeusia	30.8% 4/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Gastrointestinal disorders Dysphagia	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	53.8% 7/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
General disorders Edema limbs	38.5% 5/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Respiratory, thoracic and mediastinal disorders Epistaxis	23.1% 3/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Skin and subcutaneous tissue disorders Erythroderma	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
General disorders Facial pain	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
General disorders Fatigue	84.6% 11/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
General disorders Fever	15.4% 2/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Musculoskeletal and connective tissue disorders Flank pain	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Vascular disorders Flushing	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	15.4% 2/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	46.2% 6/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Nervous system disorders Headache	15.4% 2/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Renal and urinary disorders Hematuria	23.1% 3/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Investigations Hemoglobin increased	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Gastrointestinal disorders Hemorrhoids	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Respiratory, thoracic and mediastinal disorders Hoarseness	30.8% 4/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Vascular disorders Hot flashes	46.2% 6/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Metabolism and nutrition disorders Hypercalcemia	15.4% 2/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Metabolism and nutrition disorders Hyperglycemia	46.2% 6/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Metabolism and nutrition disorders Hyperkalemia	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Metabolism and nutrition disorders Hypermagnesemia	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Metabolism and nutrition disorders Hypernatremia	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Vascular disorders Hypertension	46.2% 6/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Metabolism and nutrition disorders Hypoalbuminemia	53.8% 7/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Metabolism and nutrition disorders Hypocalcemia	61.5% 8/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Metabolism and nutrition disorders Hypokalemia	61.5% 8/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Metabolism and nutrition disorders Hypomagnesemia	30.8% 4/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Metabolism and nutrition disorders Hyponatremia	84.6% 11/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Metabolism and nutrition disorders Hypophosphatemia	53.8% 7/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Infections and infestations Infections and infestations - thrush	23.1% 3/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Psychiatric disorders Insomnia	76.9% 10/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Blood and lymphatic system disorders Leukocytosis	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Investigations Lymphocyte count decreased	46.2% 6/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Investigations elevated LDH	30.8% 4/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Gastrointestinal disorders Mucositis oral	61.5% 8/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Musculoskeletal and connective tissue disorders Muscle weakness	23.1% 3/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Skin and subcutaneous tissue disorders Nail discoloration	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Respiratory, thoracic and mediastinal disorders Nasal congestion	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Gastrointestinal disorders Nausea	84.6% 11/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Musculoskeletal and connective tissue disorders Neck pain	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Nervous system disorders Nervous system disorders - cold sensitivity	15.4% 2/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Investigations Neutrophil count decreased	69.2% 9/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
General disorders Non-cardiac chest pain	15.4% 2/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Gastrointestinal disorders Oral dysesthesia	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Gastrointestinal disorders Oral pain	15.4% 2/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Musculoskeletal and connective tissue disorders Pain in extremity	15.4% 2/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Skin and subcutaneous tissue disorders Pain of skin	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	53.8% 7/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Nervous system disorders Paresthesia	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Nervous system disorders Peripheral sensory neuropathy	84.6% 11/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Investigations Platelet count decreased	92.3% 12/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Respiratory, thoracic and mediastinal disorders Postnasal drip	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Renal and urinary disorders Proteinuria	46.2% 6/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Skin and subcutaneous tissue disorders Pruritus	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Skin and subcutaneous tissue disorders Rash acneiform	15.4% 2/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Skin and subcutaneous tissue disorders Rash maculo-papular	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Gastrointestinal disorders Rectal hemorrhage	15.4% 2/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	30.8% 4/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Infections and infestations Skin infection	15.4% 2/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Respiratory, thoracic and mediastinal disorders Sore throat	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Ear and labyrinth disorders Tinnitus	15.4% 2/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Infections and infestations Urinary tract infection	23.1% 3/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Renal and urinary disorders Urinary tract pain	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Reproductive system and breast disorders Vaginal hemorrhage	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Gastrointestinal disorders Vomiting	46.2% 6/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Investigations Weight loss	53.8% 7/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Investigations White blood cell decreased	76.9% 10/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.
Injury, poisoning and procedural complications Wound dehiscence	7.7% 1/13 • Patients were followed for adverse events from start of treatment until resolved for about 3 years.

Additional Information

Dr. Smitha Krishnamurthi

Case Comprehensive Cancer Center

Phone: 216-844-5234

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60