Trial Outcomes & Findings for Neoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men With Localized, High Risk Prostate Cancer (NCT NCT04737109)

Last Updated: 2023-11-13

Results Overview

Combined rate of pathologic complete response (pCR) (defined as absence of pathologic disease on hematoxylin and eosin (H\&E) stain (ypT0)), or with presence of minimal residual disease (\<5 mm linearly)

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

6 participants

Primary outcome timeframe

From C1D1 until death.

Results posted on

2023-11-13

Participant Flow

Participant milestones

Participant milestones
Measure	Phase I De-Escalation Cohort, Level 1: Ipatasertib 400 mg Daily + Darolutamide 600 mg BID + ADT Cycle 0 Days 1-7: Ipatasertib Monotherapy + Androgen Deprivation Therapy (ADT) Cycle 1 Day 1+: Ipatasertib 400 mg daily (AM dose with PKs)+ Darolutamide 600 mg BID (No AM dose.PM dose taken after ipatasertib monotherapy PKs)+ ADT (per institutional standards)	Phase I De-Escalation Cohort, Level -2: Ipatasertib 200 mg Daily + Darolutamide 600 mg BID + ADT Cycle 0 Days 1-7: Ipatasertib Monotherapy + Androgen Deprivation Therapy (ADT) Cycle 1 Day 1+: Ipatasertib 200 mg daily (AM dose with PKs)+ Darolutamide 600 mg BID (No AM dose.PM dose taken after ipatasertib monotherapy PKs)+ ADT (per institutional standards)	Phase I De-Escalation Cohort, Level -2: Ipatasertib 300 mg Daily + Darolutamide 600 mg BID + ADT Cycle 0 Days 1-7: Ipatasertib Monotherapy + Androgen Deprivation Therapy (ADT) Cycle 1 Day 1+: Ipatasertib 300 mg daily (AM dose with PKs)+ Darolutamide 600 mg BID (No AM dose.PM dose taken after ipatasertib monotherapy PKs)+ ADT (per institutional standards)	Phase II Neoadjuvant Cohort,MTD: Ipatasertib 400 mg + Darolutamide 600 mg BID + ADT All Cycles: Ipatasertib + Darolutamide + ADT Ipatasertib: Ipatasertib were planned to be administered orally per Phase I cohort determined dose of 400mg daily for each cycle length of 28 days Darolutamide: Darolutamide were planned to be administered orally at a dose of 600mg BID for each cycle length of 28 days Androgen Deprivation Therapy: ADT per institutional standards
Study Treatment STARTED	6	0	0	0
Study Treatment COMPLETED	0	0	0	0
Study Treatment NOT COMPLETED	6	0	0	0
Follow up STARTED	5	0	0	0
Follow up COMPLETED	5	0	0	0
Follow up NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase I De-Escalation Cohort, Level 1: Ipatasertib 400 mg Daily + Darolutamide 600 mg BID + ADT Cycle 0 Days 1-7: Ipatasertib Monotherapy + Androgen Deprivation Therapy (ADT) Cycle 1 Day 1+: Ipatasertib 400 mg daily (AM dose with PKs)+ Darolutamide 600 mg BID (No AM dose.PM dose taken after ipatasertib monotherapy PKs)+ ADT (per institutional standards)	Phase I De-Escalation Cohort, Level -2: Ipatasertib 200 mg Daily + Darolutamide 600 mg BID + ADT Cycle 0 Days 1-7: Ipatasertib Monotherapy + Androgen Deprivation Therapy (ADT) Cycle 1 Day 1+: Ipatasertib 200 mg daily (AM dose with PKs)+ Darolutamide 600 mg BID (No AM dose.PM dose taken after ipatasertib monotherapy PKs)+ ADT (per institutional standards)	Phase I De-Escalation Cohort, Level -2: Ipatasertib 300 mg Daily + Darolutamide 600 mg BID + ADT Cycle 0 Days 1-7: Ipatasertib Monotherapy + Androgen Deprivation Therapy (ADT) Cycle 1 Day 1+: Ipatasertib 300 mg daily (AM dose with PKs)+ Darolutamide 600 mg BID (No AM dose.PM dose taken after ipatasertib monotherapy PKs)+ ADT (per institutional standards)	Phase II Neoadjuvant Cohort,MTD: Ipatasertib 400 mg + Darolutamide 600 mg BID + ADT All Cycles: Ipatasertib + Darolutamide + ADT Ipatasertib: Ipatasertib were planned to be administered orally per Phase I cohort determined dose of 400mg daily for each cycle length of 28 days Darolutamide: Darolutamide were planned to be administered orally at a dose of 600mg BID for each cycle length of 28 days Androgen Deprivation Therapy: ADT per institutional standards
Study Treatment Disease Progression	5	0	0	0
Study Treatment Death on study	1	0	0	0

Baseline Characteristics

Neoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men With Localized, High Risk Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I De-Escalation Cohort, Level 1: Ipatasertib 400 mg Daily + Darolutamide 600 mg BID + ADT n=6 Participants Cycle 0 Days 1-7: Ipatasertib Monotherapy + Androgen Deprivation Therapy (ADT) Cycle 1 Day 1+: Ipatasertib 400 mg daily (AM dose with PKs)+ Darolutamide 600 mg BID (No AM dose.PM dose taken after ipatasertib monotherapy PKs)+ ADT (per institutional standards)
Age, Continuous	68 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Gleason score Gleason Score 3	2 Participants n=5 Participants
Gleason score Gleason score 4	1 Participants n=5 Participants
Gleason score Gleason score 7	3 Participants n=5 Participants
Tumor Location Acinar Adenocarcinoma	1 Participants n=5 Participants
Tumor Location Adenocarcinoma NOS	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: From C1D1 until death.

Population: Study was terminated after the completion of Phase I accrual. No data for this cancelled Phase II objective was collected or analyzed as no prostatectomies were performed in any subject (a pre-requisite for determining pCR).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Until the completion of cycle 1, 28 days

Population: Six Phase I subjects are included in the analysis population.

A summary of all dose-limiting toxicities experienced by Phase I subjects within the first cycle (28 days) of treatment, as defined in the study protocol.

Outcome measures

Outcome measures
Measure	Phase II Neoadjuvant Cohort,MTD: Ipatasertib 400 mg + Darolutamide 600 mg BID + ADT n=6 Participants All Cycles: Ipatasertib + Darolutamide + ADT Ipatasertib: Ipatasertib were planned to be administered orally per Phase I cohort determined dose of 400mg daily for each cycle length of 28 days Darolutamide: Darolutamide were planned to be administered orally at a dose of 600mg BID for each cycle length of 28 days Androgen Deprivation Therapy: ADT per institutional standards
Summary of Dose-Limiting Toxicities	0 dose-limiting toxicities

SECONDARY outcome

Timeframe: From C1D1 until death or up to a maximum of 24 months

Population: Study was terminated after the completion of Phase I accrual. No Phase II subjects were accrued, and no data for this cancelled Phase II objective were collected or analyzed. Additionally, no subjects from the Phase I study were followed for sufficient time to collect two-year biochemical recurrence-free survival, as they did not consent for this activity.

Two year biochemical recurrence-free survival (PSA ≤ 0.2 ng/mL) will be measured in men with high risk, localized, prostate cancer that is lacking PTEN

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From C1D1 until death.

Population: Study was terminated after the completion of Phase I accrual. No Phase II subjects were accrued, treated, or evaluated for this objective, and no data for this cancelled Phase II objective was collected or analyzed. This analysis was planned in only Phase II subjects.

Rate of PSA0 (undetectable PSA on local institutions laboratory testing with testosterone recovery and no additional therapy) will be measured in men with high risk, localized, prostate cancer that is lacking PTEN.

Outcome measures

Outcome data not reported

Adverse Events

Phase I De-Escalation Cohort, Level 1: Ipatasertib 400 mg Daily + Darolutamide 600 mg BID + ADT

Serious events: 2 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Phase I De-Escalation Cohort, Level 1: Ipatasertib 400 mg Daily + Darolutamide 600 mg BID + ADT n=6 participants at risk Cycle 0 Days 1-7: Ipatasertib Monotherapy + Androgen Deprivation Therapy (ADT) Cycle 1 Day 1+: Ipatasertib 400 mg daily (AM dose with PKs)+ Darolutamide 600 mg BID (No AM dose.PM dose taken after ipatasertib monotherapy PKs)+ ADT (per institutional standards)
Infections and infestations INFECTIONS AND INFESTATIONS	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.

Other adverse events

Other adverse events
Measure	Phase I De-Escalation Cohort, Level 1: Ipatasertib 400 mg Daily + Darolutamide 600 mg BID + ADT n=6 participants at risk Cycle 0 Days 1-7: Ipatasertib Monotherapy + Androgen Deprivation Therapy (ADT) Cycle 1 Day 1+: Ipatasertib 400 mg daily (AM dose with PKs)+ Darolutamide 600 mg BID (No AM dose.PM dose taken after ipatasertib monotherapy PKs)+ ADT (per institutional standards)
Gastrointestinal disorders ABDOMINAL PAIN	33.3% 2/6 • Number of events 3 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Renal and urinary disorders ACUTE KIDNEY INJURY	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Investigations ALANINE AMINOTRANSFERASE INCREASED	16.7% 1/6 • Number of events 3 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Investigations ALKALINE PHOSPHATASE INCREASED	66.7% 4/6 • Number of events 7 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Blood and lymphatic system disorders ANEMIA	100.0% 6/6 • Number of events 12 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Metabolism and nutrition disorders ANOREXIA	66.7% 4/6 • Number of events 9 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Psychiatric disorders ANXIETY	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Musculoskeletal and connective tissue disorders ARTHRALGIA	33.3% 2/6 • Number of events 2 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Musculoskeletal and connective tissue disorders ARTHRITIS	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	16.7% 1/6 • Number of events 2 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Nervous system disorders ATAXIA	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Musculoskeletal and connective tissue disorders BACK PAIN	50.0% 3/6 • Number of events 3 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Blood and lymphatic system disorders BLOOD AND LYMPHATIC SYSTEM DISORDERS	83.3% 5/6 • Number of events 24 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Investigations BLOOD BILIRUBIN INCREASED	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Investigations BLOOD LACTATE DEHYDROGENASE INCREASED	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
General disorders CHILLS	33.3% 2/6 • Number of events 2 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Investigations CHOLESTEROL HIGH	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Gastrointestinal disorders CONSTIPATION	33.3% 2/6 • Number of events 4 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Investigations CREATININE INCREASED	33.3% 2/6 • Number of events 3 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Psychiatric disorders DEPRESSION	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Gastrointestinal disorders DIARRHEA	83.3% 5/6 • Number of events 12 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Gastrointestinal disorders DRY MOUTH	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Skin and subcutaneous tissue disorders DRY SKIN	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Nervous system disorders DYSGEUSIA	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Respiratory, thoracic and mediastinal disorders DYSPNEA	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Endocrine disorders ENDOCRINE DISORDERS	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Reproductive system and breast disorders ERECTILE DYSFUNCTION	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Eye disorders EYE DISORDERS	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Injury, poisoning and procedural complications FALL	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
General disorders FATIGUE	83.3% 5/6 • Number of events 8 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
General disorders FEVER	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
General disorders GAIT DISTURBANCE	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
General disorders GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Nervous system disorders HEADACHE	33.3% 2/6 • Number of events 2 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Gastrointestinal disorders HEMORRHOIDS	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Vascular disorders HOT FLASHES	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Metabolism and nutrition disorders HYPERCALCEMIA	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Metabolism and nutrition disorders HYPERGLYCEMIA	100.0% 6/6 • Number of events 12 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Metabolism and nutrition disorders HYPERKALEMIA	33.3% 2/6 • Number of events 3 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Metabolism and nutrition disorders HYPERLIPIDEMIA	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Vascular disorders HYPERTENSION	33.3% 2/6 • Number of events 2 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Metabolism and nutrition disorders HYPOALBUMINEMIA	33.3% 2/6 • Number of events 3 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Metabolism and nutrition disorders HYPOCALCEMIA	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Metabolism and nutrition disorders HYPOKALEMIA	16.7% 1/6 • Number of events 2 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Metabolism and nutrition disorders HYPONATREMIA	16.7% 1/6 • Number of events 2 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Metabolism and nutrition disorders HYPOPHOSPHATEMIA	33.3% 2/6 • Number of events 2 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Vascular disorders HYPOTENSION	50.0% 3/6 • Number of events 4 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Investigations INVESTIGATIONS	83.3% 5/6 • Number of events 20 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Investigations LYMPHOCYTE COUNT DECREASED	83.3% 5/6 • Number of events 9 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Metabolism and nutrition disorders METABOLISM AND NUTRITION DISORDERS	50.0% 3/6 • Number of events 11 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Gastrointestinal disorders MUCOSITIS ORAL	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Musculoskeletal and connective tissue disorders MUSCLE WEAKNESS LOWER LIMB	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Gastrointestinal disorders NAUSEA	50.0% 3/6 • Number of events 6 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Nervous system disorders NERVOUS SYSTEM DISORDERS	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Investigations NEUTROPHIL COUNT DECREASED	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Nervous system disorders PARESTHESIA	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Infections and infestations PERIPHERAL NERVE INFECTION	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	33.3% 2/6 • Number of events 2 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Investigations PLATELET COUNT DECREASED	33.3% 2/6 • Number of events 3 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Skin and subcutaneous tissue disorders PRURITUS	16.7% 1/6 • Number of events 2 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Nervous system disorders RECURRENT LARYNGEAL NERVE PALSY	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Renal and urinary disorders RENAL AND URINARY DISORDERS	50.0% 3/6 • Number of events 3 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Skin and subcutaneous tissue disorders SKIN AND SUBCUTANEOUS TISSUE DISORDERS	33.3% 2/6 • Number of events 2 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Nervous system disorders SYNCOPE	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Renal and urinary disorders URINARY RETENTION	16.7% 1/6 • Number of events 1 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Gastrointestinal disorders VOMITING	33.3% 2/6 • Number of events 2 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.
Investigations WHITE BLOOD CELL DECREASED	50.0% 3/6 • Number of events 7 • Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first or up to a maximum of 8 months. Adverse events were recorded from the time of consent for at least 30 days after treatment discontinuation or until a new anti-cancer treatment starts, whichever occurs first, per Common Terminology Criteria for Adverse Events (CTCAE) v5.

Additional Information

Annesha Majumdar

Hoosier Cancer Research Network

Phone: 3179212050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place