Trial Outcomes & Findings for Navitoclax and Vistusertib in Treating Patients With Relapsed Small Cell Lung Cancer and Other Solid Tumors (NCT NCT03366103)

Last Updated: 2023-10-17

Results Overview

Graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0. The number of participants with dose limiting toxicities at each dose level will be reported with exact binomial 95% confidence intervals. All patients who receive at least 1 dose of both study drugs, regardless of their eligibility for the study, will be evaluable for toxicity.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

15 participants

Primary outcome timeframe

Up to 30 days after last treatment, an average of 3 months

Results posted on

2023-10-17

Participant Flow

Phase 1: 03/20/2018 - 11/11/2019 Phase 2: 7/29/2020 - 5/19/2021

Participant milestones

Participant milestones
Measure	Phase 1 - Dose Level 1 Navitoclax 150 mg po qd + Vistusertib 35 mg po bid	Phase 1 - Dose Level 2 Navitoclax 250 mg po qd + Vistusertib 35 mg po bid	Phase 2 Navitoclax 150 mg po qd + Vistusertib 35 mg po bid
Overall Study STARTED	9	5	1
Overall Study COMPLETED	6	3	1
Overall Study NOT COMPLETED	3	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1 - Dose Level 1 Navitoclax 150 mg po qd + Vistusertib 35 mg po bid	Phase 1 - Dose Level 2 Navitoclax 250 mg po qd + Vistusertib 35 mg po bid	Phase 2 Navitoclax 150 mg po qd + Vistusertib 35 mg po bid
Overall Study Disease Progression	3	1	0
Overall Study Adverse Event	0	1	0

Baseline Characteristics

Navitoclax and Vistusertib in Treating Patients With Relapsed Small Cell Lung Cancer and Other Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1 - Dose Level 1 n=9 Participants Patients receive navitoclax 150 mg orally (PO) once a day (QD) and vistusertib 35 mg PO twice a day (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Phase 1 - Dose Level 2 n=5 Participants Patients receive navitoclax 250 mg PO QD and vistusertib 35 mg PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Phase 2 n=1 Participants Patients receive navitoclax 250 mg PO QD and vistusertib 35 mg PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Total n=15 Participants Total of all reporting groups
Age, Continuous	49 years n=5 Participants	67 years n=7 Participants	77 years n=5 Participants	60 years n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	14 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	12 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	9 participants n=5 Participants	5 participants n=7 Participants	1 participants n=5 Participants	15 participants n=4 Participants
Weight	75 kg n=5 Participants	68.5 kg n=7 Participants	86.2 kg n=5 Participants	75 kg n=4 Participants
Height	167.6 cm n=5 Participants	165.0 cm n=7 Participants	172.7 cm n=5 Participants	167.6 cm n=4 Participants
Body Surface Area (BSA)	1.90 m^2 n=5 Participants	1.76 m^2 n=7 Participants	2.03 m^2 n=5 Participants	1.9 m^2 n=4 Participants
Primary site of disease Appendix	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Primary site of disease Breast	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Primary site of disease Cervix	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Primary site of disease Colon	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Primary site of disease Lung	2 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants
Primary site of disease Pleura	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Asymptomatic	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Symptomatic, fully ambulatory	7 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	11 Participants n=4 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Able to carry on normal activity, minor symptoms	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 30 days after last treatment, an average of 3 months

Population: Phase 1 participants were included in this analysis. Please see AE section for additional details.

Outcome measures

Outcome measures
Measure	Phase 1 - Dose Level 1 n=6 Participants Navitoclax 150 mg po qd + Vistusertib 35 mg po bid	Phase 1 - Dose Level 2 n=3 Participants Navitoclax 250 mg po qd + Vistusertib 35 mg po bid	Navitoclax 250 mg Reduced to 150 mg + Vistusertib 35 mg Participants who initially received Navitoclax 250 mg but were reduced to navitoclax 150 mg.
Number of Participants With Dose Limiting Toxicities (Phase I) DLT	0 Participants	2 Participants	—
Number of Participants With Dose Limiting Toxicities (Phase I) No DLT	6 Participants	1 Participants	—

PRIMARY outcome

Timeframe: Up to 1.5 years

Population: Only one participant was enrolled.

Defined as Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. partial response or complete response, of the combination in patients with recurrent small cell lung cancer. The ORR will be reported with its corresponding 95% confidence interval.

Outcome measures

Outcome measures
Measure	Phase 1 - Dose Level 1 n=1 Participants Navitoclax 150 mg po qd + Vistusertib 35 mg po bid	Phase 1 - Dose Level 2 Navitoclax 250 mg po qd + Vistusertib 35 mg po bid	Navitoclax 250 mg Reduced to 150 mg + Vistusertib 35 mg Participants who initially received Navitoclax 250 mg but were reduced to navitoclax 150 mg.
Overall Response Rate (ORR) (Phase II) Partial Response (PR) or Complete Response (CR)	0 Participants	—	—
Overall Response Rate (ORR) (Phase II) Stable Disease (SD)	0 Participants	—	—
Overall Response Rate (ORR) (Phase II) Progression (PD)	1 Participants	—	—

SECONDARY outcome

Timeframe: Through Day 15

Population: Participants in both phases were included. Some data was not collected at each timepoint.

Concentrations of each study agent present in the blood at the specified time point are reported for each study agent.

Outcome measures

Outcome measures
Measure	Phase 1 - Dose Level 1 n=9 Participants Navitoclax 150 mg po qd + Vistusertib 35 mg po bid	Phase 1 - Dose Level 2 n=5 Participants Navitoclax 250 mg po qd + Vistusertib 35 mg po bid	Navitoclax 250 mg Reduced to 150 mg + Vistusertib 35 mg n=1 Participants Participants who initially received Navitoclax 250 mg but were reduced to navitoclax 150 mg.
Occurrence of a Bi-directional Pharmacokinetic (PK) Interaction Navitoclax average of individual steady-state trough concentration (avg Cmin,ss)	1145 ng/ml Standard Deviation 289	1966 ng/ml Standard Deviation 999	2283 ng/ml
Occurrence of a Bi-directional Pharmacokinetic (PK) Interaction Navitoclax Cycle 1 Day 1 Concentration 6 hours after dose (C6h)	1808 ng/ml Standard Deviation 980	3254 ng/ml Standard Deviation 1233	—
Occurrence of a Bi-directional Pharmacokinetic (PK) Interaction Navitoclax Cycle 1 Day 15 Concentration 6 hours after dose (C6h)	2260 ng/ml Standard Deviation 993	2830 ng/ml Standard Deviation 1190	3450 ng/ml
Occurrence of a Bi-directional Pharmacokinetic (PK) Interaction Navitoclax Cycle 1 Day 15 maximum concentration (Cmax)	2393 ng/ml Standard Deviation 913	3060 ng/ml Standard Deviation 1070	3910 ng/ml
Occurrence of a Bi-directional Pharmacokinetic (PK) Interaction Vistusertib average of individual steady-state trough concentration (avg Cmin,ss)	211 ng/ml Standard Deviation 207	559 ng/ml Standard Deviation 550	238.5 ng/ml
Occurrence of a Bi-directional Pharmacokinetic (PK) Interaction Vistusertib Cycle 1 Day 1 Concentration 2 hours after dose (C2h)	372 ng/ml Standard Deviation 266	419 ng/ml Standard Deviation 108	—
Occurrence of a Bi-directional Pharmacokinetic (PK) Interaction Vistusertib Cycle 1 Day 15 Concentration 2 hours after dose (C2h)	1061 ng/ml Standard Deviation 675	1032 ng/ml Standard Deviation 832	273 ng/ml

SECONDARY outcome

Timeframe: Up to 1.5 years

Population: Only one participant was enrolled.

Graded by NCI CTCAE v 4.0. The number of participants with toxicities by grade in the phase 2 study will be reported with exact binomial 95% confidence intervals.

Outcome measures

Outcome measures
Measure	Phase 1 - Dose Level 1 n=1 Participants Navitoclax 150 mg po qd + Vistusertib 35 mg po bid	Phase 1 - Dose Level 2 Navitoclax 250 mg po qd + Vistusertib 35 mg po bid	Navitoclax 250 mg Reduced to 150 mg + Vistusertib 35 mg Participants who initially received Navitoclax 250 mg but were reduced to navitoclax 150 mg.
Number of Participants Experiencing Adverse Events by Grade (Phase II) Grade 1 Adverse Events	1 participants	—	—
Number of Participants Experiencing Adverse Events by Grade (Phase II) Grade 2 Adverse Events	1 participants	—	—
Number of Participants Experiencing Adverse Events by Grade (Phase II) Grade 3 Adverse Events	0 participants	—	—
Number of Participants Experiencing Adverse Events by Grade (Phase II) Grade 4 Adverse Events	0 participants	—	—
Number of Participants Experiencing Adverse Events by Grade (Phase II) Grade 5 Adverse Events	0 participants	—	—

SECONDARY outcome

Timeframe: Up to 1.5 years

Population: Only one participant was enrolled.

Based on RECIST 1.1. Standard life table methods will be used to analyze PFS. We will report the one-year and median PFS with 95% confidence intervals.

Outcome measures

Outcome measures
Measure	Phase 1 - Dose Level 1 n=1 Participants Navitoclax 150 mg po qd + Vistusertib 35 mg po bid	Phase 1 - Dose Level 2 Navitoclax 250 mg po qd + Vistusertib 35 mg po bid	Navitoclax 250 mg Reduced to 150 mg + Vistusertib 35 mg Participants who initially received Navitoclax 250 mg but were reduced to navitoclax 150 mg.
Progression Free Survival (PFS) (Phase II)	0 Participants	—	—

SECONDARY outcome

Timeframe: At Year 1

Population: Only one participant was enrolled.

Standard life table methods will be used to analyze OS. We will report the one-year and median OS with 95% confidence intervals.

Outcome measures

Outcome measures
Measure	Phase 1 - Dose Level 1 n=1 Participants Navitoclax 150 mg po qd + Vistusertib 35 mg po bid	Phase 1 - Dose Level 2 Navitoclax 250 mg po qd + Vistusertib 35 mg po bid	Navitoclax 250 mg Reduced to 150 mg + Vistusertib 35 mg Participants who initially received Navitoclax 250 mg but were reduced to navitoclax 150 mg.
Overall Survival (OS) at Year 1 (Phase II)	0 Participants	—	—

SECONDARY outcome

Timeframe: Up to 1.5 years

Population: Only one participant was enrolled.

Based on RECIST 1.1. The proportion of patients achieving disease control will be reported with exact 95% binomial confidence intervals.

Outcome measures

Outcome measures
Measure	Phase 1 - Dose Level 1 n=1 Participants Navitoclax 150 mg po qd + Vistusertib 35 mg po bid	Phase 1 - Dose Level 2 Navitoclax 250 mg po qd + Vistusertib 35 mg po bid	Navitoclax 250 mg Reduced to 150 mg + Vistusertib 35 mg Participants who initially received Navitoclax 250 mg but were reduced to navitoclax 150 mg.
Disease Control Rate (Phase II)	0 Participants	—	—

Adverse Events

Phase 1 - Dose Level 1

Serious events: 2 serious events

Other events: 9 other events

Deaths: 6 deaths

Phase 1 - Dose Level 2

Serious events: 2 serious events

Other events: 5 other events

Deaths: 3 deaths

Phase 2

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1 - Dose Level 1 n=9 participants at risk Navitoclax 150 mg po qd + Vistusertib 35 mg po bid	Phase 1 - Dose Level 2 n=5 participants at risk Navitoclax 250 mg po qd + Vistusertib 35 mg po bid	Phase 2 n=1 participants at risk Navitoclax 150 mg po qd + Vistusertib 35 mg po bid
Gastrointestinal disorders Colonic obstruction	11.1% 1/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/9 • Up to 1.5 years	40.0% 2/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Infections and infestations Enterocolitis infectious	11.1% 1/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Metabolism and nutrition disorders Hypokalemia	0.00% 0/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Gastrointestinal disorders Diarrhea	0.00% 0/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Investigations Platelet count decreased	11.1% 1/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Investigations Blood bilirubin decreased	11.1% 1/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years

Other adverse events

Other adverse events
Measure	Phase 1 - Dose Level 1 n=9 participants at risk Navitoclax 150 mg po qd + Vistusertib 35 mg po bid	Phase 1 - Dose Level 2 n=5 participants at risk Navitoclax 250 mg po qd + Vistusertib 35 mg po bid	Phase 2 n=1 participants at risk Navitoclax 150 mg po qd + Vistusertib 35 mg po bid
Gastrointestinal disorders Diarrhea	44.4% 4/9 • Up to 1.5 years	40.0% 2/5 • Up to 1.5 years	100.0% 1/1 • Up to 1.5 years
Gastrointestinal disorders Nausea	33.3% 3/9 • Up to 1.5 years	60.0% 3/5 • Up to 1.5 years	100.0% 1/1 • Up to 1.5 years
Gastrointestinal disorders Vomiting	55.6% 5/9 • Up to 1.5 years	40.0% 2/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Gastrointestinal disorders Constipation	33.3% 3/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Gastrointestinal disorders Abdominal Pain	22.2% 2/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	100.0% 1/1 • Up to 1.5 years
Gastrointestinal disorders Mucositis oral	22.2% 2/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Gastrointestinal disorders Dry mouth	11.1% 1/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Gastrointestinal disorders Abdominal distension	11.1% 1/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Gastrointestinal disorders Cramping	11.1% 1/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Gastrointestinal disorders Dyspepsia	11.1% 1/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	100.0% 1/1 • Up to 1.5 years
Gastrointestinal disorders Frequent stool	11.1% 1/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Gastrointestinal disorders Loose stool	11.1% 1/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Gastrointestinal disorders Thrush	11.1% 1/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
General disorders Fatigue	44.4% 4/9 • Up to 1.5 years	40.0% 2/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
General disorders Edema limbs	0.00% 0/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
General disorders Fever	11.1% 1/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
General disorders Gait disturbance	11.1% 1/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
General disorders Non-cardiac chest pain	11.1% 1/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	100.0% 1/1 • Up to 1.5 years
General disorders Sweating	11.1% 1/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Investigations Alanine aminotransferase increased	22.2% 2/9 • Up to 1.5 years	40.0% 2/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Investigations Aspartate aminotransferase increased	33.3% 3/9 • Up to 1.5 years	40.0% 2/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Investigations Weight loss	0.00% 0/9 • Up to 1.5 years	40.0% 2/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Investigations Lipase increased	22.2% 2/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Investigations Platelet count decreased	11.1% 1/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Investigations Activated partial thromboplastin time prolonged	0.00% 0/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Investigations INR increased	0.00% 0/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Investigations Lymphocyte count decreased	0.00% 0/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Investigations White blood cell decreased	0.00% 0/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Metabolism and nutrition disorders Anorexia	11.1% 1/9 • Up to 1.5 years	60.0% 3/5 • Up to 1.5 years	100.0% 1/1 • Up to 1.5 years
Metabolism and nutrition disorders Dehydration	0.00% 0/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Metabolism and nutrition disorders Hypophosphatemia	11.1% 1/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Metabolism and nutrition disorders Hypocalcemia	11.1% 1/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Metabolism and nutrition disorders Hyponatremia	11.1% 1/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Musculoskeletal and connective tissue disorders Cramping	0.00% 0/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Musculoskeletal and connective tissue disorders Pain in extremity	11.1% 1/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Nervous system disorders Dizziness	11.1% 1/9 • Up to 1.5 years	40.0% 2/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Nervous system disorders Dysgeusia	0.00% 0/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Nervous system disorders Headache	0.00% 0/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Nervous system disorders Lethargy	11.1% 1/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Respiratory, thoracic and mediastinal disorders Dyspnea	22.2% 2/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Respiratory, thoracic and mediastinal disorders Postnasal drip	11.1% 1/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Respiratory, thoracic and mediastinal disorders Sore throat	11.1% 1/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Psychiatric disorders Depression	0.00% 0/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Psychiatric disorders Hallucinations	0.00% 0/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Psychiatric disorders Confusion	11.1% 1/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Psychiatric disorders Insomnia	11.1% 1/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Infections and infestations Urinary tract infection	11.1% 1/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Infections and infestations Sinusitis	11.1% 1/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Infections and infestations Upper respiratory infection	11.1% 1/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Skin and subcutaneous tissue disorders Rash maculo-papular	22.2% 2/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Skin and subcutaneous tissue disorders Nail discoloration	0.00% 0/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Skin and subcutaneous tissue disorders Skin ulceration	0.00% 0/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Skin and subcutaneous tissue disorders Alopecia	11.1% 1/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Skin and subcutaneous tissue disorders Pruritus	11.1% 1/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	100.0% 1/1 • Up to 1.5 years
Cardiac disorders Sinus tachycardia	11.1% 1/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Injury, poisoning and procedural complications Fall	0.00% 0/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Injury, poisoning and procedural complications Fracture	0.00% 0/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Blood and lymphatic system disorders Anemia	11.1% 1/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
Renal and urinary disorders Renal and urinary disorders	0.00% 0/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	100.0% 1/1 • Up to 1.5 years
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	100.0% 1/1 • Up to 1.5 years
Nervous system disorders Cognitive disturbance	0.00% 0/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	100.0% 1/1 • Up to 1.5 years
Renal and urinary disorders Dysuria	11.1% 1/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
General disorders Death NOS	22.2% 2/9 • Up to 1.5 years	20.0% 1/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years
General disorders Progressive Disease	33.3% 3/9 • Up to 1.5 years	40.0% 2/5 • Up to 1.5 years	100.0% 1/1 • Up to 1.5 years
Respiratory, thoracic and mediastinal disorders Respiratory Failure	11.1% 1/9 • Up to 1.5 years	0.00% 0/5 • Up to 1.5 years	0.00% 0/1 • Up to 1.5 years

Additional Information

Judy Murray

Johns Hopkins University/SKCCC

Phone: 443-927-3568

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60