Trial Outcomes & Findings for 5-FU, Aflibercept, and Radiation (RT) for Preoperative and Postoperative Patients With Stage II/III Rectal Cancer (NCT NCT01749956)

Last Updated: 2017-02-07

Results Overview

The Pathologic Complete Response (pCR) Rate is defined as the number of pathologic complete responders among all patients evaluable for response, including evaluable patients who did not proceed to surgery. A pCR is defined as the absence of any residual abnormality detected in a pathological specimen.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

Between days 57 and 98 after preoperative chemotherapy

Results posted on

2017-02-07

Participant Flow

Between January 2013 and July 2014, 39 patients with stage II or stage III rectal cancer were enrolled in the trial from multiple sites in the U.S.

Participant milestones

Participant milestones
Measure	FOLFOX6/Aflibercept/Radation/Surgery Preoperative Chemoradiation (6 weeks): 5-FU: 225 mg/m2 per day by intravenous continuous infusion (IV), Days 1-42; Radiation: 50.4 Gy (1.8 Gy/day) Mon-Fri, Weeks 1 thru 6; Aflibercept: 4 mg/ kg, via IV infusion, Days 1 and 15. Surgery (6 weeks from last dose of aflibercep): abdominoperineal or low anterior resection with total mesorectal excision, per standard treatment guidelines. Postoperative Chemotherapy and Aflibercept: Aflibercept (administered first): 4 mg/kg IV for approximately 1 hour; Days 1 and 15 of each 28-day cycle; Modified FOLFOX6: Leucovorin: 400 mg/m2 as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle; Oxaliplatin: 85 mg/m2 IV as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle; 5-FU: 400-mg/m2 bolus for 2 to 4 minutes followed by 2400 mg/m2 for 46 hours on Days 1 and 15 of each cycle.
Overall Study STARTED	39
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

5-FU, Aflibercept, and Radiation (RT) for Preoperative and Postoperative Patients With Stage II/III Rectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FOLFOX6/Aflibercept/Radation/Surgery n=39 Participants Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
Age, Continuous	60 years n=5 Participants
Gender Female	14 Participants n=5 Participants
Gender Male	25 Participants n=5 Participants
Race/Ethnicity, Customized White/Caucasian	38 participants n=5 Participants
Race/Ethnicity, Customized Black/African American	1 participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants
Carcinoma Stage at Initial Diagnosis Stage II	12 participants n=5 Participants
Carcinoma Stage at Initial Diagnosis Stage III	27 participants n=5 Participants
Baseline ECOG Performance Status ECOG Performance Status = 0	32 participants n=5 Participants
Baseline ECOG Performance Status ECOG Performance Status = 1	7 participants n=5 Participants
Histologic Grade at Baseline Well differentiated	4 participants n=5 Participants
Histologic Grade at Baseline Moderately differentiated	28 participants n=5 Participants
Histologic Grade at Baseline Poorly differentiated	2 participants n=5 Participants
Histologic Grade at Baseline Could not be assessed	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Between days 57 and 98 after preoperative chemotherapy

Population: All patients enrolled in the trial who were evaluable for pathologic response. Four patients were not evaluable for response.

Outcome measures

Outcome measures
Measure	FOLFOX6/Aflibercept/Radiation/Surgery n=35 Participants Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
Pathologic Complete Response Rate	7 participants

SECONDARY outcome

Timeframe: Every 3 months (±1 month) following documented progression, up to 5 years or death, whichever comes first.

Measured from date of first protocol treatment until date of death.

Outcome measures

Outcome measures
Measure	FOLFOX6/Aflibercept/Radiation/Surgery n=39 Participants Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
Overall Survival	NA participants Median OS was not reached by time of data analysis.

SECONDARY outcome

Timeframe: up to 1 year

The probability of overall survival at 6 months and 12 months from date of first protocol treatment until date of death.

Outcome measures

Outcome measures
Measure	FOLFOX6/Aflibercept/Radiation/Surgery n=39 Participants Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
Overall Survival Probability at 6 and 12 Months 6-month OS probability	0.97 probability Interval 0.82 to 0.99
Overall Survival Probability at 6 and 12 Months 12 month OS probability	0.94 probability Interval 0.79 to 0.99

SECONDARY outcome

Timeframe: Between days 57 and 98 after preoperative chemotherapy.

The percentage of patients who had Low Anterior Resection during surgery..

Outcome measures

Outcome measures
Measure	FOLFOX6/Aflibercept/Radiation/Surgery n=39 Participants Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
Sphincter Preservation Rate	62 percentage of patients

SECONDARY outcome

Timeframe: Patients without evidence of progression will be followed every 3 months (±1 month) from date of last dose of study drug during Years 1-2, every 6 months during Years 3-4, and annually thereafter or until disease progression, estimated 5 years.

Population: All evaluable patients.

Outcome measures

Outcome measures
Measure	FOLFOX6/Aflibercept/Radiation/Surgery n=33 Participants Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
Disease-Free Survival	NA percentage of participants At a median follow-up of 12 months, median DFS was not reached.

SECONDARY outcome

Timeframe: Up to 1 year

The probability of disease free survival at 6 and 12 months after initiating protocol treatment.

Outcome measures

Outcome measures
Measure	FOLFOX6/Aflibercept/Radiation/Surgery n=33 Participants Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
Disease Free Survival Probability at 6 and 12 Months 6-month DFS probability	0.95 probability Interval 0.71 to 0.99
Disease Free Survival Probability at 6 and 12 Months 12-month DFS probability	0.87 probability Interval 0.54 to 0.97

SECONDARY outcome

Timeframe: weekly for 6 weeks pre-op then every 2 weeks post-op, approximately 36 weeks

Population: All patients who received at least one dose of protocol treatment.

Adverse events and serious adverse events (AEs and SAEs) were graded according to National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE) v4.0. Specific AE and SAE terms are provided in the Adverse Event module.

Outcome measures

Outcome measures
Measure	FOLFOX6/Aflibercept/Radiation/Surgery n=39 Participants Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
The Number of Participants Who Experienced Serious or Non-Serious Adverse Events as a Measure of Safety. AEs	38 participants
The Number of Participants Who Experienced Serious or Non-Serious Adverse Events as a Measure of Safety. SAEs	9 participants

Adverse Events

FOLFOX6/Aflibercept/Radiation/Surgery

Serious events: 9 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FOLFOX6/Aflibercept/Radiation/Surgery n=39 participants at risk Preoperative Chemoradiation: 5-FU: 225 mg/m2 per day by intravenous continuous infusion (IVCI), Days 1 thru 42; Radiation: 50.4 Gy (1.8 Gy/day or 28 fractions) Mon thru Fri, Weeks 1 thru 6; Aflibercept: 4 mg/ kg, via IV infusion, Days 1 and 15. Surgery: Patients will undergo abdominoperineal or low anterior resection with total mesorectal excision, per standard treatment guidelines. Postoperative Chemotherapy and Aflibercept Treatments: Aflibercept (administered first): 4 mg/kg IV for approximately 1 hour (no more than 2 hours) on Days 1 and 15 of each cycle. Modified FOLFOX6: * Leucovorin: 400 mg/m2 as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle. * Oxaliplatin: 85 mg/m2 IV as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle. * 5-FU: 400-mg/m2 bolus for 2 to 4 minutes followed by 2400 mg/m2 for 46 hours on Days 1 and 15 of each cycle. Radiation Aflibercept Surgery: Abdominoperineal or low anterior resectio
Infections and infestations Pelvic Abscess	5.1% 2/39 • Number of events 2 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Gastrointestinal disorders Small Intestinal Obstruction	5.1% 2/39 • Number of events 2 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Infections and infestations Abscess	2.6% 1/39 • Number of events 1 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Metabolism and nutrition disorders Dehydration	2.6% 1/39 • Number of events 1 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Infections and infestations Device Related Infection	2.6% 1/39 • Number of events 1 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Vascular disorders Embolism Venous	2.6% 1/39 • Number of events 1 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Gastrointestinal disorders Enteritis	2.6% 1/39 • Number of events 1 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Gastrointestinal disorders Faecaloma	2.6% 1/39 • Number of events 1 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Gastrointestinal disorders Gastrointestinal Fistula	2.6% 1/39 • Number of events 1 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Gastrointestinal disorders Gastrointestinal Haemorrhage	2.6% 1/39 • Number of events 1 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
General disorders Mucosal Inflammation	2.6% 1/39 • Number of events 1 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Blood and lymphatic system disorders Neutropenia	2.6% 1/39 • Number of events 1 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Gastrointestinal disorders Rectal Ulcer	2.6% 1/39 • Number of events 1 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Infections and infestations Sepsis	2.6% 1/39 • Number of events 1 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.

Other adverse events

Other adverse events
Measure	FOLFOX6/Aflibercept/Radiation/Surgery n=39 participants at risk Preoperative Chemoradiation: 5-FU: 225 mg/m2 per day by intravenous continuous infusion (IVCI), Days 1 thru 42; Radiation: 50.4 Gy (1.8 Gy/day or 28 fractions) Mon thru Fri, Weeks 1 thru 6; Aflibercept: 4 mg/ kg, via IV infusion, Days 1 and 15. Surgery: Patients will undergo abdominoperineal or low anterior resection with total mesorectal excision, per standard treatment guidelines. Postoperative Chemotherapy and Aflibercept Treatments: Aflibercept (administered first): 4 mg/kg IV for approximately 1 hour (no more than 2 hours) on Days 1 and 15 of each cycle. Modified FOLFOX6: * Leucovorin: 400 mg/m2 as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle. * Oxaliplatin: 85 mg/m2 IV as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle. * 5-FU: 400-mg/m2 bolus for 2 to 4 minutes followed by 2400 mg/m2 for 46 hours on Days 1 and 15 of each cycle. Radiation Aflibercept Surgery: Abdominoperineal or low anterior resectio
Gastrointestinal disorders Diarrheoea	74.4% 29/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
General disorders Fatigue	74.4% 29/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Gastrointestinal disorders Nausea	51.3% 20/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Vascular disorders Hypertension	41.0% 16/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
General disorders Muscousal Inflammation	41.0% 16/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Renal and urinary disorders Proteinuria	38.5% 15/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Gastrointestinal disorders Constipation	35.9% 14/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Nervous system disorders Headache	33.3% 13/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Gastrointestinal disorders Proctalgia	30.8% 12/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Blood and lymphatic system disorders Anaemia	28.2% 11/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Metabolism and nutrition disorders Decreased Appetite	25.6% 10/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Metabolism and nutrition disorders Dehydration	23.1% 9/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Blood and lymphatic system disorders Neutropenia	25.6% 10/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Gastrointestinal disorders Abdominal Pain	20.5% 8/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Respiratory, thoracic and mediastinal disorders Dysphonia	20.5% 8/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Blood and lymphatic system disorders Thrombocytopenia	20.5% 8/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Investigations Weight Decreased	20.5% 8/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Nervous system disorders Dysgeusia	17.9% 7/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Respiratory, thoracic and mediastinal disorders Epistaxis	17.9% 7/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Gastrointestinal disorders Stomatitis	17.9% 7/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Gastrointestinal disorders Vomiting	17.9% 7/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Musculoskeletal and connective tissue disorders Arthralgia	15.4% 6/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	15.4% 6/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Skin and subcutaneous tissue disorders Palmar-Plantar Erythrodysaesthesia Syndrome	15.4% 6/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Gastrointestinal disorders Rectal Haemorrhage	15.4% 6/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	15.4% 6/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Renal and urinary disorders Haematuria	12.8% 5/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Skin and subcutaneous tissue disorders Rash	12.8% 5/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
General disorders Temperature Intolerance	12.8% 5/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Infections and infestations Device Related Infection	12.8% 5/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.3% 4/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Metabolism and nutrition disorders Hypokalaemia	10.3% 4/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Blood and lymphatic system disorders Leukopenia	10.3% 4/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Musculoskeletal and connective tissue disorders Pain in Extremity	10.3% 4/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Nervous system disorders Peripheral Sensory Neuropathy	10.3% 4/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Injury, poisoning and procedural complications Radiation Skin Injury	10.3% 4/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Infections and infestations Upper Respiratory Tract Infection	10.3% 4/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
General disorders Asthenia	7.7% 3/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Musculoskeletal and connective tissue disorders Back Pain	7.7% 3/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
General disorders Catheter Site Pain	7.7% 3/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Skin and subcutaneous tissue disorders Dry Skin	7.7% 3/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Musculoskeletal and connective tissue disorders Myalgia	7.7% 3/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Investigations Neutrophil Count Decreased	7.7% 3/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Nervous system disorders Paraesthesia	7.7% 3/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Gastrointestinal disorders Dyspepsia	5.1% 2/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Metabolism and nutrition disorders Hyperkalaemia	5.1% 2/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	5.1% 2/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Gastrointestinal disorders Oral Pain	5.1% 2/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.
Nervous system disorders Peripheral Neuropathy	25.6% 10/39 • From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months. All patients who received at least one dose of protocol treatment during the trial.

Additional Information

Charles Davis, RAC

SCRI Development Innovations

Phone: 615-524-4341

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
Publication restrictions are in place

Restriction type: OTHER