Trial Outcomes & Findings for Veliparib, Topotecan Hydrochloride, and Filgrastim or Pegfilgrastim in Treating Patients With Persistent or Recurrent Cervical Cancer (NCT NCT01266447)

Last Updated: 2019-08-08

Results Overview

Complete and Partial Tumor Response as Assessed by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), at least 30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicted based on symptoms or physical signs suggestive of progressive disease. The average time was 2.3 months

Results posted on

2019-08-08

Participant Flow

The study was activated on 2/7/2011 and closed to accrual on 1/17/2013.

Participant milestones

Participant milestones
Measure	ABT-888, Topotecan and Filgrastim or Pegfilgrastim ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
Overall Study STARTED	27
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Veliparib, Topotecan Hydrochloride, and Filgrastim or Pegfilgrastim in Treating Patients With Persistent or Recurrent Cervical Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ABT-888, Topotecan and Filgrastim or Pegfilgrastim n=27 Participants ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	49.8 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants

PRIMARY outcome

Timeframe: Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicted based on symptoms or physical signs suggestive of progressive disease. The average time was 2.3 months

Population: Eligible and Treated Patients

Outcome measures

Outcome measures
Measure	ABT-888, Topotecan and Filgrastim or Pegfilgrastim n=27 Participants ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
Tumor Response	7.4 percentage of participants Interval 2.0 to 100.0

PRIMARY outcome

Timeframe: Up to 21 days

Population: The first 6 eligible and treated patients who completed the 1st cycle of study treatment or had a DLT prior to completing the first cycle of study treatment

A dose-limiting toxicity (DLT) is assessed by NCI CTCAE v4, occurring during cycle 1 of therapy.: A dose-limiting toxicity (DLT) is defined as either hematologic or non-hematologic toxicity assessed by NCI CTCAE v4, occurring during cycle 1 of therapy, which cause any of the following: For hematologic toxicity - dose delay of greater than 2 weeks due to failure to recover counts, Treatment related febrile neutropenia, grade 4 neutropenia lasting \>7 days, treatment related grade 4 thrombocytopenia or clinically significant bleeding with grade 3 thrombocytopenia. For non-hematologic toxicity; study treatment related grade 3 or 4 non-hematological toxicity (excluding anorexia, constipation, fatigue, hypersensitivity/allergic reaction to one of the study drugs, nausea \& vomiting, and grade 3 dehydration), grade 4 nausea and vomiting for \>48 hours despite maximum medical management, electrolyte imbalance of \> or equal to grade 3 that can be replaced within 48 hours; any drug related death

Outcome measures

Outcome measures
Measure	ABT-888, Topotecan and Filgrastim or Pegfilgrastim n=6 Participants ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
Number of Patients With Dose-limiting Toxicities (in Safety lead-in)	1 participants

PRIMARY outcome

Timeframe: During treatment period and up to 30 days after stopping the study treatment.The average of study treatment time was 2.3 months.

Population: Eligible and treated patients - No statistical analysis provided for adverse events (grade 3 or higher) during treatment period.

Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.

Outcome measures

Outcome measures
Measure	ABT-888, Topotecan and Filgrastim or Pegfilgrastim n=27 Participants ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
Adverse Events (Grade 3 or Higher) During Treatment Period Infections and Infestations	4 Participants
Adverse Events (Grade 3 or Higher) During Treatment Period Leukopenia	6 Participants
Adverse Events (Grade 3 or Higher) During Treatment Period Thrombocytopenia	12 Participants
Adverse Events (Grade 3 or Higher) During Treatment Period Neutropenia	5 Participants
Adverse Events (Grade 3 or Higher) During Treatment Period Anemia	16 Participants
Adverse Events (Grade 3 or Higher) During Treatment Period Other Investigations	4 Participants
Adverse Events (Grade 3 or Higher) During Treatment Period Cardiac Disorders	1 Participants
Adverse Events (Grade 3 or Higher) During Treatment Period Gastrointestinal Disorders	7 Participants
Adverse Events (Grade 3 or Higher) During Treatment Period General Disorders & administration site conditions	5 Participants
Adverse Events (Grade 3 or Higher) During Treatment Period Metabolism and nutrition disorders	3 Participants
Adverse Events (Grade 3 or Higher) During Treatment Period Musculoskeletal and connective tissue disorders	5 Participants
Adverse Events (Grade 3 or Higher) During Treatment Period Neoplasms benign, malignant and unspecified	1 Participants
Adverse Events (Grade 3 or Higher) During Treatment Period Nervous system disorders	1 Participants
Adverse Events (Grade 3 or Higher) During Treatment Period Renal and urinary disorders	0 Participants
Adverse Events (Grade 3 or Higher) During Treatment Period Reproductive system and breast disorders	2 Participants
Adverse Events (Grade 3 or Higher) During Treatment Period Respiratory, thoracic and mediastinal disorders	4 Participants
Adverse Events (Grade 3 or Higher) During Treatment Period Surgical and medical procedures	1 Participants
Adverse Events (Grade 3 or Higher) During Treatment Period Vascular disorders	3 Participants

SECONDARY outcome

Timeframe: From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.

Population: Eligible and Treated Patients

Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is defined as at least a 20% increase in the sum of the longest dimensions (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions, or global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or death due to disease without prior objective documentation of progression.

Outcome measures

Outcome measures
Measure	ABT-888, Topotecan and Filgrastim or Pegfilgrastim n=27 Participants ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
Progression-free Survival	2.0 months Interval 1.3 to 3.4

SECONDARY outcome

Timeframe: From study entry to death or last contact, up to 5 years of follow-up.

Population: Eligible and Treated Patients

Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

Outcome measures

Outcome measures
Measure	ABT-888, Topotecan and Filgrastim or Pegfilgrastim n=27 Participants ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
Overall Survival	8.2 months Interval 5.8 to 10.6

SECONDARY outcome

Timeframe: Every other cycle for first 6 months; then every 3 months until disease progression confirmed; and at any other time if clinically indicated based on symptoms or signs suggestive of progressive disease.The average of study treatment time was 2.3 months.

Population: Eligible and Treated Patients with objective response

Duration of objective response is defined as the duration from the time measurement criteria is met for partial or complete response by RECIST 1.1, whichever is first recorded, until the first date the recurrent or progressive disease is objectively documented. Per Response Evaluation Criteria in Solid Tumors (RECIST) criteria Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), at least 30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation.

Outcome measures

Outcome measures
Measure	ABT-888, Topotecan and Filgrastim or Pegfilgrastim n=2 Participants ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
Duration of Objective Response	5.3 Months Interval 4.0 to 6.7

Adverse Events

ABT-888, Topotecan and Filgrastim or Pegfilgrastim

Serious events: 16 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ABT-888, Topotecan and Filgrastim or Pegfilgrastim n=27 participants at risk ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
Cardiac disorders Heart Failure	3.7% 1/27 • Number of events 1 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Gastrointestinal disorders Vomiting	3.7% 1/27 • Number of events 1 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Gastrointestinal disorders Upper Gastrointestinal Hemorrhage	3.7% 1/27 • Number of events 1 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Gastrointestinal disorders Small Intestinal Perforation	3.7% 1/27 • Number of events 1 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Gastrointestinal disorders Small Intestinal Obstruction	3.7% 1/27 • Number of events 1 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Gastrointestinal disorders Abdominal Pain	7.4% 2/27 • Number of events 2 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
General disorders Death Nos	7.4% 2/27 • Number of events 2 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Infections and infestations Infections And Infestations - Other	3.7% 1/27 • Number of events 1 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Infections and infestations Sepsis	3.7% 1/27 • Number of events 1 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Infections and infestations Urinary Tract Infection	3.7% 1/27 • Number of events 1 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Investigations Platelet Count Decreased	7.4% 2/27 • Number of events 2 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Metabolism and nutrition disorders Hypokalemia	3.7% 1/27 • Number of events 1 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Musculoskeletal and connective tissue disorders Pain In Extremity	3.7% 1/27 • Number of events 1 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms Benign, Malignant And Unspecified (Incl	3.7% 1/27 • Number of events 1 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Reproductive system and breast disorders Pelvic Pain	3.7% 1/27 • Number of events 1 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Respiratory, thoracic and mediastinal disorders Respiratory, Thoracic And Mediastinal Disorders	3.7% 1/27 • Number of events 1 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	3.7% 1/27 • Number of events 1 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Surgical and medical procedures Surgical And Medical Procedures - Other	3.7% 1/27 • Number of events 1 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Vascular disorders Thromboembolic Event	3.7% 1/27 • Number of events 1 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.

Other adverse events

Other adverse events
Measure	ABT-888, Topotecan and Filgrastim or Pegfilgrastim n=27 participants at risk ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
Blood and lymphatic system disorders Anemia	100.0% 27/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Cardiac disorders Heart Failure	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Cardiac disorders Sinus Tachycardia	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Ear and labyrinth disorders Ear And Labyrinth Disorders - Other	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Ear and labyrinth disorders Tinnitus	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Ear and labyrinth disorders Ear Pain	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Endocrine disorders Endocrine Disorders - Other	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Gastrointestinal disorders Dysphagia	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Gastrointestinal disorders Dyspepsia	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Gastrointestinal disorders Dry Mouth	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Gastrointestinal disorders Constipation	37.0% 10/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Gastrointestinal disorders Diarrhea	25.9% 7/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Gastrointestinal disorders Vomiting	29.6% 8/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Gastrointestinal disorders Salivary Duct Inflammation	7.4% 2/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Gastrointestinal disorders Abdominal Pain	25.9% 7/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Gastrointestinal disorders Rectal Hemorrhage	7.4% 2/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Gastrointestinal disorders Mucositis Oral	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Gastrointestinal disorders Lower Gastrointestinal Hemorrhage	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Gastrointestinal disorders Nausea	55.6% 15/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Gastrointestinal disorders Hemorrhoidal Hemorrhage	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Gastrointestinal disorders Ascites	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Gastrointestinal disorders Flatulence	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
General disorders General Disorders And Administration Site Conditio	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
General disorders Pain	25.9% 7/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
General disorders Malaise	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
General disorders Localized Edema	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
General disorders Non-Cardiac Chest Pain	7.4% 2/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
General disorders Edema Limbs	7.4% 2/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
General disorders Fatigue	81.5% 22/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
General disorders Fever	11.1% 3/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
General disorders Chills	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Infections and infestations Infections And Infestations - Other	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Infections and infestations Upper Respiratory Infection	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Infections and infestations Skin Infection	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Infections and infestations Sinusitis	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Infections and infestations Sepsis	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Infections and infestations Vaginal Infection	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Infections and infestations Urinary Tract Infection	18.5% 5/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Infections and infestations Lip Infection	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Injury, poisoning and procedural complications Fracture	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Injury, poisoning and procedural complications Fall	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Injury, poisoning and procedural complications Bruising	14.8% 4/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Investigations Weight Loss	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Investigations Weight Gain	7.4% 2/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Investigations Platelet Count Decreased	85.2% 23/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Investigations Lymphocyte Count Decreased	14.8% 4/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Investigations Inr Increased	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Investigations Ggt Increased	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Investigations Creatinine Increased	11.1% 3/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Investigations Neutrophil Count Decreased	44.4% 12/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Investigations Blood Bilirubin Increased	7.4% 2/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Investigations White Blood Cell Decreased	55.6% 15/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Investigations Aspartate Aminotransferase Increased	7.4% 2/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Investigations Alkaline Phosphatase Increased	29.6% 8/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Investigations Alanine Aminotransferase Increased	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Investigations Activated Partial Thromboplastin Time Prolonged	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Metabolism and nutrition disorders Hypophosphatemia	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Metabolism and nutrition disorders Hyponatremia	11.1% 3/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Metabolism and nutrition disorders Hypomagnesemia	29.6% 8/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Metabolism and nutrition disorders Hypokalemia	37.0% 10/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Metabolism and nutrition disorders Hypoglycemia	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Metabolism and nutrition disorders Hypocalcemia	22.2% 6/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Metabolism and nutrition disorders Hypoalbuminemia	29.6% 8/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Metabolism and nutrition disorders Hypernatremia	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Metabolism and nutrition disorders Hyperkalemia	7.4% 2/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Metabolism and nutrition disorders Hyperglycemia	25.9% 7/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Metabolism and nutrition disorders Anorexia	33.3% 9/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Musculoskeletal and connective tissue disorders Pain In Extremity	14.8% 4/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Musculoskeletal and connective tissue disorders Myalgia	7.4% 2/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Musculoskeletal and connective tissue disorders Musculoskeletal Deformity	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Musculoskeletal and connective tissue disorders Generalized Muscle Weakness	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Musculoskeletal and connective tissue disorders Flank Pain	7.4% 2/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Musculoskeletal and connective tissue disorders Bone Pain	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Musculoskeletal and connective tissue disorders Back Pain	22.2% 6/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 3/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Musculoskeletal and connective tissue disorders Musculoskeletal And Connective Tissue Disorder -	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Nervous system disorders Peripheral Sensory Neuropathy	29.6% 8/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Nervous system disorders Peripheral Motor Neuropathy	7.4% 2/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Nervous system disorders Memory Impairment	7.4% 2/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Nervous system disorders Lethargy	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Nervous system disorders Headache	18.5% 5/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Nervous system disorders Dysgeusia	11.1% 3/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Nervous system disorders Dysarthria	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Nervous system disorders Dizziness	14.8% 4/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Nervous system disorders Depressed Level Of Consciousness	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Nervous system disorders Ataxia	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Psychiatric disorders Insomnia	22.2% 6/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Psychiatric disorders Depression	14.8% 4/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Psychiatric disorders Confusion	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Psychiatric disorders Anxiety	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Psychiatric disorders Agitation	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Renal and urinary disorders Urinary Tract Obstruction	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Renal and urinary disorders Urinary Incontinence	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Renal and urinary disorders Proteinuria	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Renal and urinary disorders Hematuria	11.1% 3/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Renal and urinary disorders Cystitis Noninfective	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Reproductive system and breast disorders Vaginal Hemorrhage	7.4% 2/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Reproductive system and breast disorders Pelvic Pain	7.4% 2/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Reproductive system and breast disorders Vaginal Discharge	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Respiratory, thoracic and mediastinal disorders Postnasal Drip	7.4% 2/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	7.4% 2/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	7.4% 2/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Respiratory, thoracic and mediastinal disorders Productive Cough	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Respiratory, thoracic and mediastinal disorders Hoarseness	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	29.6% 8/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Respiratory, thoracic and mediastinal disorders Cough	22.2% 6/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Respiratory, thoracic and mediastinal disorders Atelectasis	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Respiratory, thoracic and mediastinal disorders Allergic Rhinitis	7.4% 2/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Skin and subcutaneous tissue disorders Skin And Subcutaneous Tissue Disorders - Other	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	7.4% 2/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Skin and subcutaneous tissue disorders Hyperhidrosis	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Skin and subcutaneous tissue disorders Erythema Multiforme	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Skin and subcutaneous tissue disorders Dry Skin	7.4% 2/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Skin and subcutaneous tissue disorders Alopecia	40.7% 11/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Vascular disorders Vascular Disorders - Other	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Vascular disorders Thromboembolic Event	14.8% 4/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Vascular disorders Lymphedema	11.1% 3/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Vascular disorders Hypotension	11.1% 3/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Vascular disorders Hypertension	7.4% 2/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Vascular disorders Hot Flashes	11.1% 3/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.
Vascular disorders Flushing	3.7% 1/27 • During treatment period and up to 30 days after stopping the study treatment. The average of study treatment time was 2.3 months.

Additional Information

Linda Gedeon, Clinical Data Coordinator

NRG Oncology

Phone: 716-845-1169

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60