Trial Outcomes & Findings for Durvalumab Plus CV301 With Maintenance Chemotherapy in Metastatic Colorectal or Pancreatic Adenocarcinoma (NCT NCT03376659)

Last Updated: 2024-02-05

Results Overview

The Recommended Phase II dose of durvalumab in the combination of durvalumab plus CV301 with maintenance chemotherapy as determined by the Phase I design

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

8 participants

Primary outcome timeframe

6 months

Results posted on

2024-02-05

Participant Flow

Study terminated during Phase I. No subjects enrolled in Phase II.

Participant milestones

Participant milestones
Measure	Phase I - Safety- Colorectal Cancer Arm * MVA-BN-CV301 (prime) - Day 1 and Day 29. * FPV-CV301 (boost) - Day 1 of Weeks 9, 13, 17, 21, 25, 37, and q24 weeks starting week 53. * Durvalumab - q2 weeks * Capecitabine - twice a day, Monday - Friday Weekly * Bevacizumab - q2weeks (colorectal cancer patients only) Durvalumab: 750mg IV q2 weeks CV301: MVA-BN-CV301 (prime) - two priming doses of 1.6 x 109 infectious units/0.5 mL (Inf.U) given subcutaneously (s.c.) FPV-CV301 (boost) - dosed at 1 × 109 Inf.U/0.5 mL given s.c. Capecitabine: 1000mg orally twice a day, Monday - Friday Weekly Bevacizumab: 5mg/kg IV q2weeks	Phase I - Safety- Pancreatic Cancer Arm * MVA-BN-CV301 (prime) - Day 1 and Day 29. * FPV-CV301 (boost) - Day 1 of Weeks 9, 13, 17, 21, 25, 37, and q24 weeks starting week 53. * Durvalumab - q2 weeks * Capecitabine - twice a day, Monday - Friday Weekly Durvalumab: 750mg IV q2 weeks CV301: MVA-BN-CV301 (prime) - two priming doses of 1.6 x 109 infectious units/0.5 mL (Inf.U) given subcutaneously (s.c.) FPV-CV301 (boost) - dosed at 1 × 109 Inf.U/0.5mL given s.c. Capecitabine: 1000mg orally twice a day,Monday - Friday Weekly
Overall Study STARTED	4	4
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Durvalumab Plus CV301 With Maintenance Chemotherapy in Metastatic Colorectal or Pancreatic Adenocarcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I - Safety- All Groups n=8 Participants * MVA-BN-CV301 (prime) - Day 1 and Day 29. * FPV-CV301 (boost) - Day 1 of Weeks 9, 13, 17, 21, 25, 37, and q24 weeks starting week 53. * Durvalumab - q2 weeks * Capecitabine - twice a day, Monday - Friday Weekly * Bevacizumab - q2weeks (colorectal cancer patients only) Durvalumab: 750mg IV q2 weeks CV301: MVA-BN-CV301 (prime) - two priming doses of 1.6 x 109 infectious units/0.5 mL (Inf.U) given subcutaneously (s.c.) FPV-CV301 (boost) - dosed at 1 × 109 Inf.U/0.5 mL given s.c. Capecitabine: 1000mg orally twice a day, Monday - Friday Weekly Bevacizumab: 5mg/kg IV q2weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 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	1 Participants n=5 Participants
Race (NIH/OMB) White	7 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

PRIMARY outcome

Timeframe: 6 months

Population: Phase 1 not completed because study terminated due to lack of enrollment. Recommended phase II dose could not be determined.

The Recommended Phase II dose of durvalumab in the combination of durvalumab plus CV301 with maintenance chemotherapy as determined by the Phase I design

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 24 months

Population: colorectal cancer

To determine the progression free survival (PFS) of durvalumab plus CV301 in combination with maintenance capecitabine and bevacizumab in patients with metastatic colorectal cancer, whose disease is stable on, or responding to 1st line therapy for metastatic disease

Outcome measures

Outcome measures
Measure	Phase I - Safety n=4 Participants * MVA-BN-CV301 (prime) - Day 1 and Day 29. * FPV-CV301 (boost) - Day 1 of Weeks 9, 13, 17, 21, 25, 37, and q24 weeks starting week 53. * Durvalumab - q2 weeks * Capecitabine - twice a day, Monday - Friday Weekly * Bevacizumab - q2weeks (colorectal cancer patients only) Durvalumab: 750mg IV q2 weeks CV301: MVA-BN-CV301 (prime) - two priming doses of 1.6 x 109 infectious units/0.5 mL (Inf.U) given subcutaneously (s.c.) FPV-CV301 (boost) - dosed at 1 × 109 Inf.U/0.5 mL given s.c. Capecitabine: 1000mg orally twice a day, Monday - Friday Weekly Bevacizumab: 5mg/kg IV q2weeks
Progression Free Survival (PFS) Colorectal Cancer	7.4 months Interval 3.2 to 12.9

PRIMARY outcome

Timeframe: 24 months

Population: pancreatic cancer

To determine the progression free survival rate (PFS) of durvalumab plus CV301 in combination with maintenance capecitabine in patients with metastatic pancreatic cancer, whose disease is stable on, or responding to 1st line therapy for metastatic disease

Outcome measures

Outcome measures
Measure	Phase I - Safety n=4 Participants * MVA-BN-CV301 (prime) - Day 1 and Day 29. * FPV-CV301 (boost) - Day 1 of Weeks 9, 13, 17, 21, 25, 37, and q24 weeks starting week 53. * Durvalumab - q2 weeks * Capecitabine - twice a day, Monday - Friday Weekly * Bevacizumab - q2weeks (colorectal cancer patients only) Durvalumab: 750mg IV q2 weeks CV301: MVA-BN-CV301 (prime) - two priming doses of 1.6 x 109 infectious units/0.5 mL (Inf.U) given subcutaneously (s.c.) FPV-CV301 (boost) - dosed at 1 × 109 Inf.U/0.5 mL given s.c. Capecitabine: 1000mg orally twice a day, Monday - Friday Weekly Bevacizumab: 5mg/kg IV q2weeks
Progression Free Survival (PFS) Pancreatic Cancer	4.5 months Interval 2.8 to 7.3

SECONDARY outcome

Timeframe: 1 year

ORR is defined as the proportion of patients whose best overall response recorded during treatment is either CR or PR according to the RECIST version 1.1.

Outcome measures

Outcome measures
Measure	Phase I - Safety n=8 Participants * MVA-BN-CV301 (prime) - Day 1 and Day 29. * FPV-CV301 (boost) - Day 1 of Weeks 9, 13, 17, 21, 25, 37, and q24 weeks starting week 53. * Durvalumab - q2 weeks * Capecitabine - twice a day, Monday - Friday Weekly * Bevacizumab - q2weeks (colorectal cancer patients only) Durvalumab: 750mg IV q2 weeks CV301: MVA-BN-CV301 (prime) - two priming doses of 1.6 x 109 infectious units/0.5 mL (Inf.U) given subcutaneously (s.c.) FPV-CV301 (boost) - dosed at 1 × 109 Inf.U/0.5 mL given s.c. Capecitabine: 1000mg orally twice a day, Monday - Friday Weekly Bevacizumab: 5mg/kg IV q2weeks
Objective Response Rate (ORR)	2 Participants

SECONDARY outcome

Timeframe: 24 months

PFS is defined as the time from consenting to determination of tumor progression by RECIST version 1.1 or death due to any cause, whichever occurs first.

Outcome measures

Outcome measures
Measure	Phase I - Safety n=8 Participants * MVA-BN-CV301 (prime) - Day 1 and Day 29. * FPV-CV301 (boost) - Day 1 of Weeks 9, 13, 17, 21, 25, 37, and q24 weeks starting week 53. * Durvalumab - q2 weeks * Capecitabine - twice a day, Monday - Friday Weekly * Bevacizumab - q2weeks (colorectal cancer patients only) Durvalumab: 750mg IV q2 weeks CV301: MVA-BN-CV301 (prime) - two priming doses of 1.6 x 109 infectious units/0.5 mL (Inf.U) given subcutaneously (s.c.) FPV-CV301 (boost) - dosed at 1 × 109 Inf.U/0.5 mL given s.c. Capecitabine: 1000mg orally twice a day, Monday - Friday Weekly Bevacizumab: 5mg/kg IV q2weeks
Progression Free Survival (PFS)	4.7 months Interval 2.8 to 12.9

SECONDARY outcome

Timeframe: 4 years

Population: number of subjects still alive at the end of the study follow up

To determine overall survival, subjects will be followed from time of consent until death (or until study termination). Subject will be followed for survival after discontinuing study medication and after the adverse event collection period has ended.

Outcome measures

Outcome measures
Measure	Phase I - Safety n=8 Participants * MVA-BN-CV301 (prime) - Day 1 and Day 29. * FPV-CV301 (boost) - Day 1 of Weeks 9, 13, 17, 21, 25, 37, and q24 weeks starting week 53. * Durvalumab - q2 weeks * Capecitabine - twice a day, Monday - Friday Weekly * Bevacizumab - q2weeks (colorectal cancer patients only) Durvalumab: 750mg IV q2 weeks CV301: MVA-BN-CV301 (prime) - two priming doses of 1.6 x 109 infectious units/0.5 mL (Inf.U) given subcutaneously (s.c.) FPV-CV301 (boost) - dosed at 1 × 109 Inf.U/0.5 mL given s.c. Capecitabine: 1000mg orally twice a day, Monday - Friday Weekly Bevacizumab: 5mg/kg IV q2weeks
Overall Survival (OS)	1 Participants

SECONDARY outcome

Timeframe: 4 months

DCR is defined as the proportion of patients with a documented CR, PR, or SD at 4 months according to the RECIST version 1.1.

Outcome measures

Outcome measures
Measure	Phase I - Safety n=8 Participants * MVA-BN-CV301 (prime) - Day 1 and Day 29. * FPV-CV301 (boost) - Day 1 of Weeks 9, 13, 17, 21, 25, 37, and q24 weeks starting week 53. * Durvalumab - q2 weeks * Capecitabine - twice a day, Monday - Friday Weekly * Bevacizumab - q2weeks (colorectal cancer patients only) Durvalumab: 750mg IV q2 weeks CV301: MVA-BN-CV301 (prime) - two priming doses of 1.6 x 109 infectious units/0.5 mL (Inf.U) given subcutaneously (s.c.) FPV-CV301 (boost) - dosed at 1 × 109 Inf.U/0.5 mL given s.c. Capecitabine: 1000mg orally twice a day, Monday - Friday Weekly Bevacizumab: 5mg/kg IV q2weeks
Disease Control Rate (DCR)	5 Participants

SECONDARY outcome

Timeframe: 2 years

Tolerability and safety of the combination as determined by the number of patients with treatment emergent adverse events

Outcome measures

Outcome measures
Measure	Phase I - Safety n=8 Participants * MVA-BN-CV301 (prime) - Day 1 and Day 29. * FPV-CV301 (boost) - Day 1 of Weeks 9, 13, 17, 21, 25, 37, and q24 weeks starting week 53. * Durvalumab - q2 weeks * Capecitabine - twice a day, Monday - Friday Weekly * Bevacizumab - q2weeks (colorectal cancer patients only) Durvalumab: 750mg IV q2 weeks CV301: MVA-BN-CV301 (prime) - two priming doses of 1.6 x 109 infectious units/0.5 mL (Inf.U) given subcutaneously (s.c.) FPV-CV301 (boost) - dosed at 1 × 109 Inf.U/0.5 mL given s.c. Capecitabine: 1000mg orally twice a day, Monday - Friday Weekly Bevacizumab: 5mg/kg IV q2weeks
Tolerability and Safety of the Combination	8 Participants

SECONDARY outcome

Timeframe: 1 year

The duration of response will also be captured as the time from which a response was first identified, until progression of disease according to the RECIST version 1.1 (or death due to any cause).

Outcome measures

Outcome measures
Measure	Phase I - Safety n=8 Participants * MVA-BN-CV301 (prime) - Day 1 and Day 29. * FPV-CV301 (boost) - Day 1 of Weeks 9, 13, 17, 21, 25, 37, and q24 weeks starting week 53. * Durvalumab - q2 weeks * Capecitabine - twice a day, Monday - Friday Weekly * Bevacizumab - q2weeks (colorectal cancer patients only) Durvalumab: 750mg IV q2 weeks CV301: MVA-BN-CV301 (prime) - two priming doses of 1.6 x 109 infectious units/0.5 mL (Inf.U) given subcutaneously (s.c.) FPV-CV301 (boost) - dosed at 1 × 109 Inf.U/0.5 mL given s.c. Capecitabine: 1000mg orally twice a day, Monday - Friday Weekly Bevacizumab: 5mg/kg IV q2weeks
Duration of Response	145 days Interval 59.0 to 172.0

Adverse Events

Phase I - Safety

Serious events: 0 serious events

Other events: 8 other events

Deaths: 7 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Phase I - Safety n=8 participants at risk * MVA-BN-CV301 (prime) - Day 1 and Day 29. * FPV-CV301 (boost) - Day 1 of Weeks 9, 13, 17, 21, 25, 37, and q24 weeks starting week 53. * Durvalumab - q2 weeks * Capecitabine - twice a day, Monday - Friday Weekly * Bevacizumab - q2weeks (colorectal cancer patients only) Durvalumab: 750mg IV q2 weeks CV301: MVA-BN-CV301 (prime) - two priming doses of 1.6 x 109 infectious units/0.5 mL (Inf.U) given subcutaneously (s.c.) FPV-CV301 (boost) - dosed at 1 × 109 Inf.U/0.5 mL given s.c. Capecitabine: 1000mg orally twice a day, Monday - Friday Weekly Bevacizumab: 5mg/kg IV q2weeks
Blood and lymphatic system disorders Lymph node pain	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Cardiac disorders Pericardial effusion	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Endocrine disorders Hypothyroidism	37.5% 3/8 • Number of events 3 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Gastrointestinal disorders Abdominal pain	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Gastrointestinal disorders Anal hemorrhage	25.0% 2/8 • Number of events 2 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Gastrointestinal disorders Constipation	12.5% 1/8 • Number of events 2 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Gastrointestinal disorders Diarrhea	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Gastrointestinal disorders Dry mouth	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify: Stomatitis	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Gastrointestinal disorders Mucositis oral	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Gastrointestinal disorders Nausea	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Gastrointestinal disorders Periodontal disease	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
General disorders Chills	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
General disorders Fatigue	50.0% 4/8 • Number of events 6 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
General disorders Fever	25.0% 2/8 • Number of events 2 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
General disorders Injection site reaction	75.0% 6/8 • Number of events 6 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Immune system disorders Allergic Reaction	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Infections and infestations Infections and infestations - Other, specify: Influenza	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Investigations Alanine aminotransferase increased	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Investigations Alkaline phosphatase increased	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Investigations Weight gain	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Investigations White blood cell decreased	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Metabolism and nutrition disorders Hypoalbuminemia	25.0% 2/8 • Number of events 2 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Metabolism and nutrition disorders Hypokalemia	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Metabolism and nutrition disorders Hyponatremia	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 2/8 • Number of events 2 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Musculoskeletal and connective tissue disorders Back pain	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Musculoskeletal and connective tissue disorders Bone pain	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Musculoskeletal and connective tissue disorders Flank Pain	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Musculoskeletal and connective tissue disorders Myalgia	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Musculoskeletal and connective tissue disorders Neck Pain	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Musculoskeletal and connective tissue disorders Pain in extremity	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Nervous system disorders Dizziness	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Nervous system disorders Dysgeusia	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Nervous system disorders Peripheral sensory neuropathy	37.5% 3/8 • Number of events 4 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Psychiatric disorders Anxiety	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Renal and urinary disorders Renal and urinary disorders - Other, specify	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Reproductive system and breast disorders Erectile dysfunction	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Respiratory, thoracic and mediastinal disorders Cough	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	25.0% 2/8 • Number of events 2 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Respiratory, thoracic and mediastinal disorders Epistaxis	25.0% 2/8 • Number of events 2 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Skin and subcutaneous tissue disorders Dry skin	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Skin and subcutaneous tissue disorders Rash maculo-papular	25.0% 2/8 • Number of events 2 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Vascular disorders Hypertension	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Reproductive system and breast disorders Amenorrhea	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
General disorders flu like symptoms	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Skin and subcutaneous tissue disorders Pimple lesions	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Skin and subcutaneous tissue disorders Pruritus	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Gastrointestinal disorders gingival hemorrhage	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
General disorders left upper arm mass	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Gastrointestinal disorders oral hemorrhage	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Investigations Aspartate aminotransferase increased	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Gastrointestinal disorders Gingival Pain	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Investigations Lipase Increased	12.5% 1/8 • Number of events 3 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Nervous system disorders Paresthesia	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.
Vascular disorders Thromboembolic Event	12.5% 1/8 • Number of events 1 • Adverse events and serious adverse events were assessed from time of written informed consent is obtained through 90 days after the last dose, 2 years. All-Cause Mortality was assessed up to 4 years.

Additional Information

Benjamin Weinberg, MD

Georgetown University

Phone: 202-444-2223

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place