Trial Outcomes & Findings for Neoadjuvant Therapy for Ovarian Cancer (NCT NCT01146795)

Last Updated: 2021-02-09

Results Overview

This is to assess the feasibility of delivering multiple cycles of the study treatment without excessive dose modification or cycle delays. The regimen would be considered unfeasible for further study if there were 5 or more of the following events within the first 15 patients, 7 or more of these events within the first 30 patients, or 8 or more of these events within the first 45 patients: * Delay of day 1 of therapy \> 3 weeks from the expected day 1 of that cycle * Febrile neutropenia requiring hospitalization * Grade 4 thrombocytopenia * Grade 1-5 gastrointestinal perforation * Grade 3-4 hemorrhagic toxicity * Grade 3-4 arterial thromboembolic complications * Grade 4 hypertension * Grade 4 proteinuria * Fascial dehiscence

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

32 participants

Primary outcome timeframe

Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months)

Results posted on

2021-02-09

Participant Flow

No significant events in the study that occurred after participant enrollment but prior to assignment of participants to an arm or group.

Participant milestones

Participant milestones
Measure	Carboplatin, Paclitaxel, and Bevacizumab Three 21 day cycles of carboplatin, paclitaxel, and bevacizumab. After 3 cycles of chemotherapy patients will be considered for surgical cytoreduction. After surgical cytoreduction all patients will receive an additional 6 cycles of chemotherapy (cycles 4-9) regardless of disease status at the time of exploration. Chemotherapy should be re-instituted within 6 weeks of the surgical procedure.
Overall Study STARTED	32
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Carboplatin, Paclitaxel, and Bevacizumab Three 21 day cycles of carboplatin, paclitaxel, and bevacizumab. After 3 cycles of chemotherapy patients will be considered for surgical cytoreduction. After surgical cytoreduction all patients will receive an additional 6 cycles of chemotherapy (cycles 4-9) regardless of disease status at the time of exploration. Chemotherapy should be re-instituted within 6 weeks of the surgical procedure.
Overall Study Withdrawal by Subject	4
Overall Study Adverse Event	6
Overall Study Still in treatment at study closure	10

Baseline Characteristics

Neoadjuvant Therapy for Ovarian Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Carboplatin, Paclitaxel, and Bevacizumab n=32 Participants Three 21 day cycles of carboplatin, paclitaxel, and bevacizumab. After 3 cycles of chemotherapy patients will be considered for surgical cytoreduction. After surgical cytoreduction all patients will receive an additional 6 cycles of chemotherapy (cycles 4-9) regardless of disease status at the time of exploration. Chemotherapy should be re-instituted within 6 weeks of the surgical procedure.
Age, Customized Age · 40-49	3 Participants n=5 Participants
Age, Customized Age · 50-59	4 Participants n=5 Participants
Age, Customized Age · 60-69	13 Participants n=5 Participants
Age, Customized Age · 70-79	9 Participants n=5 Participants
Age, Customized Age · 80-89	3 Participants n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	32 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months)

Population: 32 patients, out of the 45 targeted accrual, were enrolled during the study period. In the first 30 patients, toxicities were analyzed for this outcome measure.

Outcome measures

Outcome measures
Measure	Carboplatin, Paclitaxel, and Bevacizumab n=30 Participants Three 21 day cycles of carboplatin, paclitaxel, and bevacizumab. After 3 cycles of chemotherapy patients will be considered for surgical cytoreduction. After surgical cytoreduction all patients will receive an additional 6 cycles of chemotherapy (cycles 4-9) regardless of disease status at the time of exploration. Chemotherapy should be re-instituted within 6 weeks of the surgical procedure.
Number of Protocol Defined Adverse Events in Patients Receiving Neoadjuvant Carboplatin, Paclitaxel, and Bevacizumab	7 protocol defined adverse events

SECONDARY outcome

Timeframe: Cycle 3, Cycle 6, Cycle 9 and 3 years post-treatment

Population: 31 patients, out of 32 enrolled, were potential candidates for surgery and included in the analysis for this outcome measure. At the time of study, data was only analyzed after 3 cycles of treatment.

The percentage of patients whose cancer shrinks or disappears after treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	Carboplatin, Paclitaxel, and Bevacizumab n=31 Participants Three 21 day cycles of carboplatin, paclitaxel, and bevacizumab. After 3 cycles of chemotherapy patients will be considered for surgical cytoreduction. After surgical cytoreduction all patients will receive an additional 6 cycles of chemotherapy (cycles 4-9) regardless of disease status at the time of exploration. Chemotherapy should be re-instituted within 6 weeks of the surgical procedure.
Response Rate Complete response	6.5 percentage of patients
Response Rate Partial response	71.0 percentage of patients
Response Rate Stable disease	22.6 percentage of patients

SECONDARY outcome

Timeframe: Baseline, Cycle 3, Cycle 6, Cycle 9

Population: A total of 30 patients contributed data to QOL at baseline, not all patients completed the subsequent cycles as demonstrated in the "Number Analyzed" at Cycles 3, 6 and 9.

The FACT Quality of Life (QOL) Score questionnaire is designed to assess the effects of cancer and its treatment on the quality of life, by measuring aspects of an individual's sense of well-being and ability to carry out various activities. When calculating the total QOL score, the score scale of functional well-being was reversed in order to keep consistent with other three domains. The lower the total score, the better the quality of life. The five-point scale ranges from 0 (not at all) to 4 (very much). Scoring the FACT-G is performed through a simple sum of item scores. Each subscale is scored, and a total score for the FACT-G is obtained by adding each of the subscale scores. With a total possible score greater than 100, additional scoring methods have been used to simplify interpretation. Modifications of scoring include normalizing the total score on a scale of 0-100 through mathematical transformations, as well as the use of a Trial Outcome Index (TOI).

Outcome measures

Outcome measures
Measure	Carboplatin, Paclitaxel, and Bevacizumab n=30 Participants Three 21 day cycles of carboplatin, paclitaxel, and bevacizumab. After 3 cycles of chemotherapy patients will be considered for surgical cytoreduction. After surgical cytoreduction all patients will receive an additional 6 cycles of chemotherapy (cycles 4-9) regardless of disease status at the time of exploration. Chemotherapy should be re-instituted within 6 weeks of the surgical procedure.
Quality of Life (QOL) Score Baseline Quality of Life (QOL) Score	6 score on a scale Standard Deviation 4
Quality of Life (QOL) Score Cycle 3 Quality of Life (QOL) Score	7.4 score on a scale Standard Deviation 5.7
Quality of Life (QOL) Score Cycle 6 Quality of Life (QOL) Score	8.9 score on a scale Standard Deviation 6.2
Quality of Life (QOL) Score Cycle 9 Quality of Life (QOL) Score	6.6 score on a scale Standard Deviation 4.3

SECONDARY outcome

Timeframe: Up to 3 years

The length of time during and after the treatment of cancer, that a patient lives with the disease but it does not get worse.

Outcome measures

Outcome measures
Measure	Carboplatin, Paclitaxel, and Bevacizumab n=32 Participants Three 21 day cycles of carboplatin, paclitaxel, and bevacizumab. After 3 cycles of chemotherapy patients will be considered for surgical cytoreduction. After surgical cytoreduction all patients will receive an additional 6 cycles of chemotherapy (cycles 4-9) regardless of disease status at the time of exploration. Chemotherapy should be re-instituted within 6 weeks of the surgical procedure.
Progression-free Survival (PFS)	16.8 months Interval 12.7 to 20.8

Adverse Events

Carboplatin, Paclitaxel, and Bevacizumab

Serious events: 3 serious events

Other events: 31 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Carboplatin, Paclitaxel, and Bevacizumab n=32 participants at risk Three 21 day cycles of carboplatin, paclitaxel, and bevacizumab. After 3 cycles of chemotherapy patients will be considered for surgical cytoreduction. After surgical cytoreduction all patients will receive an additional 6 cycles of chemotherapy (cycles 4-9) regardless of disease status at the time of exploration. Chemotherapy should be re-instituted within 6 weeks of the surgical procedure.
Blood and lymphatic system disorders Febrile neutropenia	6.2% 2/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Thrombocytopenia	3.1% 1/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.

Other adverse events

Other adverse events
Measure	Carboplatin, Paclitaxel, and Bevacizumab n=32 participants at risk Three 21 day cycles of carboplatin, paclitaxel, and bevacizumab. After 3 cycles of chemotherapy patients will be considered for surgical cytoreduction. After surgical cytoreduction all patients will receive an additional 6 cycles of chemotherapy (cycles 4-9) regardless of disease status at the time of exploration. Chemotherapy should be re-instituted within 6 weeks of the surgical procedure.
Nervous system disorders Sensory neuropathy	90.6% 29/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Nervous system disorders Motor neuropathy	6.2% 2/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Nervous system disorders Mood alteration: Anxiety	9.4% 3/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Nervous system disorders Headache	18.8% 6/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Nervous system disorders Gait Abnormal	6.2% 2/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Nervous system disorders Dizziness	28.1% 9/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Respiratory, thoracic and mediastinal disorders Cough	34.4% 11/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Respiratory, thoracic and mediastinal disorders Voice alteration	9.4% 3/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Respiratory, thoracic and mediastinal disorders Dyspnea	25.0% 8/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	6.2% 2/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Edema, limb	15.6% 5/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Musculoskeletal and connective tissue disorders Edema, trunk/genital	6.2% 2/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Decreased hemoglobin	96.9% 31/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Decreased Leukocytes	81.2% 26/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Decreased ANC	93.8% 30/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Hyponatremia	34.4% 11/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Hypoglycemia	9.4% 3/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Hypercalcemia	9.4% 3/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Hypocalcemia	21.9% 7/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Hyperglycemia	53.1% 17/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Hypoalbuminemia	21.9% 7/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Hyperkalemia	15.6% 5/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Hypokalemia	6.2% 2/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Hypomagnesemia	34.4% 11/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Elevated AST/SGOT	12.5% 4/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Alkaline phosphatase increased	9.4% 3/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Hemolysis	12.5% 4/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders INR increased	12.5% 4/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders PTT increased	9.4% 3/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Blood and lymphatic system disorders Decreased platelets	71.9% 23/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Respiratory, thoracic and mediastinal disorders Hemorrhage, nasal	21.9% 7/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Nausea	68.8% 22/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Vomiting	18.8% 6/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Taste alteration	15.6% 5/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Anorexia	43.8% 14/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Diarrhea	43.8% 14/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Flatulence	6.2% 2/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Constipation	75.0% 24/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Abdominal distension	15.6% 5/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Heartburn	21.9% 7/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Gastric mucositis	6.2% 2/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Gastritis	6.2% 2/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Toothache	6.2% 2/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Fever	15.6% 5/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Sweating	12.5% 4/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Insomnia	31.2% 10/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Fatigue	75.0% 24/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Weight loss	21.9% 7/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Rigors	25.0% 8/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders Dry skin	12.5% 4/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders Flushing skin	18.8% 6/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders Pruritus	15.6% 5/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders Rash	25.0% 8/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders Alopecia	40.6% 13/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders Acne	9.4% 3/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Skin and subcutaneous tissue disorders Hyperpigmentation	6.2% 2/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Ear and labyrinth disorders Ear, nose and throat exam abnormal	18.8% 6/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Vascular disorders Hypertension	56.2% 18/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Cardiac disorders Palpitations	12.5% 4/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Vascular disorders Hot flashes	9.4% 3/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Immune system disorders Rhinitis	28.1% 9/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Renal and urinary disorders Increased creatinine	15.6% 5/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Renal and urinary disorders Proteinuria	25.0% 8/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Renal and urinary disorders Urine incontinence	9.4% 3/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Surgical and medical procedures Wound complication - non-infectious	6.2% 2/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Musculoskeletal and connective tissue disorders Back pain	9.4% 3/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Musculoskeletal and connective tissue disorders Neck pain	6.2% 2/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Abdominal pain	28.1% 9/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Gastrointestinal disorders Joint pain	46.9% 15/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	21.9% 7/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Musculoskeletal and connective tissue disorders Pain in extremity	15.6% 5/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
General disorders Pain	9.4% 3/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Musculoskeletal and connective tissue disorders Myalgia	34.4% 11/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Infections and infestations Febrile neutropenia	6.2% 2/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Infections and infestations Urinary tract infection	6.2% 2/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Infections and infestations Infection, other	6.2% 2/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Immune system disorders Cytokine release syndrome	6.2% 2/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Vascular disorders Thrombosis	6.2% 2/32 • Up to 30 days after completion of 9 cycles of treatment and/or early discontinuation (approximately up to 12 months). Adverse Events Definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.

Additional Information

Jason Wright, MD

Columbia University

Phone: 212-305-3410

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place