Trial Outcomes & Findings for Phase II Trial of Vemurafenib and Sorafenib in Pancreatic Cancer (NCT NCT05068752)

Last Updated: 2026-03-30

Results Overview

Disease control rate (DCR) is defined as the combination of patients with complete response + partial response + stable disease at 16 weeks, divided by the total number of patients. Response is defined using RECIST v1.1 imaging criteria.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Initiation of study treatment until 16 weeks.

Results posted on

2026-03-30

Participant Flow

Participant milestones

Participant milestones
Measure	Vemurafenib in Combination With Sorafenib Vemurafenib 480 mg PO BID combined with sorafenib 200 mg PO BID daily for 28 days per cycle.
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Unknown status for one (1) subject.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vemurafenib in Combination With Sorafenib n=9 Participants Vemurafenib 480 mg PO BID combined with sorafenib 200 mg PO BID daily for 28 days per cycle.
Age, Continuous	62.8 years n=9 Participants
Sex: Female, Male Female	4 Participants n=9 Participants
Sex: Female, Male Male	5 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	2 Participants n=9 Participants
Race (NIH/OMB) White	7 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=9 Participants
Region of Enrollment United States	9 Participants n=9 Participants
Eastern Cooperative Oncology Group (ECOG) Score 0 - 1	9 Participants n=9 Participants
Cancer Antigen 19-9 (CA 19-9) < 35 U/mL	3 Participants n=8 Participants • Unknown status for one (1) subject.
Cancer Antigen 19-9 (CA 19-9) ≥ 35 U/mL	5 Participants n=8 Participants • Unknown status for one (1) subject.
Primary Tumor Location Head	6 Participants n=9 Participants
Primary Tumor Location Body	2 Participants n=9 Participants
Primary Tumor Location Tail	1 Participants n=9 Participants
Site of Metastasis Liver	4 Participants n=9 Participants
Site of Metastasis Lung	1 Participants n=9 Participants
Site of Metastasis Other	1 Participants n=9 Participants
Site of Metastasis Multiple sites	3 Participants n=9 Participants
Number of Prior Lines of Therapy 2 prior lines of therapy	1 Participants n=9 Participants
Number of Prior Lines of Therapy 3 prior lines of therapy	5 Participants n=9 Participants
Number of Prior Lines of Therapy 4 prior lines of therapy	3 Participants n=9 Participants

PRIMARY outcome

Timeframe: Initiation of study treatment until 16 weeks.

Outcome measures

Outcome measures
Measure	Vemurafenib in Combination With Sorafenib n=9 Participants Vemurafenib 480 mg PO BID combined with sorafenib 200 mg PO BID daily for 28 days per cycle.
Disease Control Rate (DCR)	0 DCR, % of participants with CR/PR/SD

SECONDARY outcome

Timeframe: Initiation of study treatment up to 30 days post treatment, an average of 90 days

The number of patients who experienced an adverse event (AE) determined to be possibly or definitely related to the study treatment of vemurafenib + sorafenib. Adverse events occurring were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE). Grade refers to the severity of the AE and are given on a 1-5 scale, with each scale having unique clinical descriptions of severity for each AE based on this general guideline: * Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. * Grade 2: Moderate; minimal, local or noninvasive intervention indicated * Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling * Grade 4: Life-threatening consequences; urgent intervention indicated. * Grade 5: Death related to AE. Note: All AEs were grade 3 or lower in this study.

Outcome measures

Outcome measures
Measure	Vemurafenib in Combination With Sorafenib n=9 Participants Vemurafenib 480 mg PO BID combined with sorafenib 200 mg PO BID daily for 28 days per cycle.
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Anemia · Grade 1	0 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Anemia · Grade 2	0 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Anemia · Grade 3	1 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Anemia · Not Affected	8 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Diarrhea · Grade 1	0 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Diarrhea · Grade 2	1 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Diarrhea · Grade 3	0 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Diarrhea · Not Affected	8 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Nausea · Grade 1	2 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Nausea · Grade 2	0 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Nausea · Grade 3	0 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Nausea · Not Affected	7 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Vomiting · Grade 1	2 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Vomiting · Grade 2	0 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Vomiting · Grade 3	0 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Vomiting · Not Affected	7 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Fatigue · Grade 1	0 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Fatigue · Grade 2	1 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Fatigue · Grade 3	0 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Fatigue · Not Affected	8 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Hypokalemia · Grade 1	1 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Hypokalemia · Grade 2	0 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Hypokalemia · Grade 3	0 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Hypokalemia · Not Affected	8 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Hypophosphatemia · Grade 1	0 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Hypophosphatemia · Grade 2	3 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Hypophosphatemia · Grade 3	1 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Hypophosphatemia · Not Affected	5 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Arthralgia · Grade 1	0 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Arthralgia · Grade 2	1 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Arthralgia · Grade 3	0 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Arthralgia · Not Affected	8 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Arthritis · Grade 1	1 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Arthritis · Grade 2	0 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Arthritis · Grade 3	0 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Arthritis · Not Affected	8 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Pain in extremity · Grade 1	0 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Pain in extremity · Grade 2	1 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Pain in extremity · Grade 3	0 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Pain in extremity · Not Affected	8 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Squamous Cell Carcinoma · Grade 1	1 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Squamous Cell Carcinoma · Grade 2	0 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Squamous Cell Carcinoma · Grade 3	0 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Squamous Cell Carcinoma · Not Affected	8 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Dry skin · Grade 1	2 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Dry skin · Grade 2	0 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Dry skin · Grade 3	0 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Dry skin · Not Affected	7 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Pruritus · Grade 1	0 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Pruritus · Grade 2	2 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Pruritus · Grade 3	0 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Pruritus · Not Affected	7 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Rash maculo-papular · Grade 1	1 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Rash maculo-papular · Grade 2	3 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Rash maculo-papular · Grade 3	1 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Rash maculo-papular · Not Affected	4 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Hypertension · Grade 1	0 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Hypertension · Grade 2	2 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Hypertension · Grade 3	0 Participants
Adverse Events Possibly or Definitely Related to Vemurafenib in Combination Wit Sorafenib Hypertension · Not Affected	7 Participants

SECONDARY outcome

Timeframe: Initiation of study treatment up to study completion, up to 2 years.

Progression-free survival (PFS) is defined as first dose treated until the date of disease progression as measured by imaging using RECIST v1.1 criteria.

Outcome measures

Outcome measures
Measure	Vemurafenib in Combination With Sorafenib n=9 Participants Vemurafenib 480 mg PO BID combined with sorafenib 200 mg PO BID daily for 28 days per cycle.
Progression-free Survival (PFS)	1.6 months Interval 0.5 to The upper bound of the 95% CI cannot be estimated due to the small sample size and uncertainty in the data.

SECONDARY outcome

Timeframe: Initiation of study treatment up to study completion, up to 2 years.

Survival was defined as the time from initiation of study treatment (C1/D1) to date of death. In the absence of confirmation of death, survival time was censored at the last date the patient was known to be alive.

Outcome measures

Outcome measures
Measure	Vemurafenib in Combination With Sorafenib n=9 Participants Vemurafenib 480 mg PO BID combined with sorafenib 200 mg PO BID daily for 28 days per cycle.
Overall Survival (OS)	2.9 months Interval 0.6 to 5.4

SECONDARY outcome

Timeframe: Initiation of study treatment to end of study treatment, up to 90 days.

Population: Of n=9 total participants, plasma levels of phospho-ERK measured at baseline for n=6, at C2D1 for n=6, at C3D1 for n=5, and at EOT for n=1.

Phospho-ERK is a key downstream effector of the RAS/RAF/MEK signaling pathway that is proposed to be targeted by vemurafenib and sorafenib treatment. Plasma levels of phospho-ERK were measured over multiple treatment timepoints to gain molecular insight into targeted pathway suppression of the study regimen. Six patients who had blood samples available for the baseline (screen) and at least one on- or post-treatment time point were included in this analysis. Timepoints include Baseline, Cycle 2 Day 1 (C2D1), Cycle 3 Day 1 (C3D1), and End of Treatment (EOT).

Outcome measures

Outcome measures
Measure	Vemurafenib in Combination With Sorafenib n=6 Participants Vemurafenib 480 mg PO BID combined with sorafenib 200 mg PO BID daily for 28 days per cycle.
Percent Change in Plasma Levels of Phospho-ERK From Baseline C2D1	87.4 Percent change from baseline, % Interval 75.4 to 111.1
Percent Change in Plasma Levels of Phospho-ERK From Baseline C3D1	75.1 Percent change from baseline, % Interval 61.0 to 101.7
Percent Change in Plasma Levels of Phospho-ERK From Baseline EOT	79.1 Percent change from baseline, % Interval 79.1 to 79.1

SECONDARY outcome

Timeframe: Initiation of study treatment to end of study treatment, up to 90 days.

Population: Of n=9 total participants, plasma levels of phospho-AKT measured at baseline for n=6, at C2D1 for n=6, at C3D1 for n=5, and at EOT for n=1.

Phospho-AKT is a key downstream effector of the RAS/RAF/MEK signaling pathway that is proposed to be targeted by vemurafenib and sorafenib treatment. Plasma levels of phospho-AKT were measured over multiple treatment timepoints to gain molecular insight into targeted pathway suppression of the study regimen. Six patients who had blood samples available for the baseline (screen) and at least one on- or post-treatment time point were included in this analysis. Timepoints include Baseline, Cycle 2 Day 1 (C2D1), Cycle 3 Day 1 (C3D1), and End of Treatment (EOT).

Outcome measures

Outcome measures
Measure	Vemurafenib in Combination With Sorafenib n=6 Participants Vemurafenib 480 mg PO BID combined with sorafenib 200 mg PO BID daily for 28 days per cycle.
Percent Change in Plasma Levels of Phospho-AKT From Baseline C2D1	130.9 Percent change from baseline Interval 92.3 to 237.3
Percent Change in Plasma Levels of Phospho-AKT From Baseline C3D1	143.3 Percent change from baseline Interval 67.5 to 157.1
Percent Change in Plasma Levels of Phospho-AKT From Baseline EOT	140.6 Percent change from baseline Interval 140.6 to 140.6

Adverse Events

Vemurafenib in Combination With Sorafenib

Serious events: 4 serious events

Other events: 9 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Vemurafenib in Combination With Sorafenib n=9 participants at risk Vemurafenib 480 mg PO BID combined with sorafenib 200 mg PO BID daily for 28 days per cycle.
Gastrointestinal disorders Abdominal pain	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Infections and infestations Urinary tract infection	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Infections and infestations Sepsis	22.2% 2/9 • Number of events 2 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).

Other adverse events

Other adverse events
Measure	Vemurafenib in Combination With Sorafenib n=9 participants at risk Vemurafenib 480 mg PO BID combined with sorafenib 200 mg PO BID daily for 28 days per cycle.
Investigations White blood cell decreased	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Metabolism and nutrition disorders Anorexia	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Metabolism and nutrition disorders Dehydration	11.1% 1/9 • Number of events 2 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Metabolism and nutrition disorders Hypercalcemia	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Metabolism and nutrition disorders Hypoglycemia	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Metabolism and nutrition disorders Hypokalemia	55.6% 5/9 • Number of events 5 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Metabolism and nutrition disorders Hyponatremia	11.1% 1/9 • Number of events 2 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Metabolism and nutrition disorders Hypophosphatemia	44.4% 4/9 • Number of events 5 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Metabolism and nutrition disorders Iron Deficiency	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Musculoskeletal and connective tissue disorders Arthritis	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Musculoskeletal and connective tissue disorders Back pain	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Blood and lymphatic system disorders Anemia	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Gastrointestinal disorders Abdominal pain	33.3% 3/9 • Number of events 3 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Gastrointestinal disorders Diarrhea	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Gastrointestinal disorders Dry mouth	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Gastrointestinal disorders Duodenal hemorrhage	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Gastrointestinal disorders Gastroesophageal reflux	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Gastrointestinal disorders Gastroparesis	22.2% 2/9 • Number of events 2 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Gastrointestinal disorders Nausea	55.6% 5/9 • Number of events 5 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Gastrointestinal disorders Stomach pain	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Gastrointestinal disorders Vomiting	55.6% 5/9 • Number of events 5 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
General disorders Fatigue	33.3% 3/9 • Number of events 3 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
General disorders Fever	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Hepatobiliary disorders Biliary Obstruction	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Infections and infestations Catheter related infection	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Infections and infestations Lung infection	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Injury, poisoning and procedural complications Wound dehiscence	11.1% 1/9 • Number of events 2 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Investigations Creatinine increased	22.2% 2/9 • Number of events 2 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Musculoskeletal and connective tissue disorders Flank pain	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Musculoskeletal and connective tissue disorders Generalized muscle weakness	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Musculoskeletal and connective tissue disorders Pain in extremity	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Nervous system disorders Akathisia	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Nervous system disorders Cognitive disturbance	22.2% 2/9 • Number of events 2 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Psychiatric disorders Depression	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Reproductive system and breast disorders Pelvic pain	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Skin and subcutaneous tissue disorders Dry skin	22.2% 2/9 • Number of events 2 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Skin and subcutaneous tissue disorders Hyperhidrosis	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Skin and subcutaneous tissue disorders Pain of Skin	11.1% 1/9 • Number of events 3 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Skin and subcutaneous tissue disorders Pruritus	33.3% 3/9 • Number of events 3 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Skin and subcutaneous tissue disorders Rash maculo-papular	55.6% 5/9 • Number of events 11 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Surgical and medical procedures Port-a-cath Malfunction	11.1% 1/9 • Number of events 1 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).
Vascular disorders Hypertension	33.3% 3/9 • Number of events 3 • From enrollment until 30 days following the last dose of study treatment, an average of 90 days Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v5.0 (CTCAE).

Additional Information

Erkut H. Borazanci, MD

HonorHealth Research Institute

Phone: 4805837120

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place