Trial Outcomes & Findings for Study of Aflibercept as Maintenance Therapy Following Induction With Aflibercept in Combination With XELOX, as First-Line Treatment for Metastatic Colorectal Cancer Patient (NCT NCT01955629)

NCT ID: NCT01955629

Last Updated: 2016-04-18

Results Overview

DLTs were assessed using the national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) version 4.03. DLTs were defined as any of following AEs: grade 4 neutropenia lasting \>7 consecutive days; febrile neutropenia or neutropenic infection; grade 4 thrombocytopenia; grade 3 thrombocytopenia associated with bleeding requiring transfusion; grade 4 non-hematological treatment related event; grade 3 nausea/vomiting or diarrhea lasting \>/= 4 days despite corrective measures; grade 3 other non-hematological toxicities: anorexia, fatigue, hypertension only if G4 or not medically controlled and G3 peripheral sensory neuropathy that did not improve to G\<2 at time of retreatment; urinary protein excretion of \>3.5 gram per 24 hours that did not recover to \<2.0 gram per 24 hours within 2 weeks; symptomatic arterial thromboembolic events including cerebrovascular accidents, myocardial infarction, transient ischemic attacks, new onset or worsening of pre-existing angina.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Cycle 1 (Up to 3 weeks)

Results posted on

2016-04-18

Participant Flow

The study was conducted at 2 sites in Italy. A total of 6 participants were screened between 17 Dec 2013 and 24 Feb 2014, out of which 4 participants were enrolled and treated.

Participants enrolled in Part-1 of study to assess recommended phase 2 dose (RP2D) of combination of aflibercept with oxaliplatin and capecitabine. 3 participants discontinued due to adverse events (AE) and 1 participant due to disease progression (DP) at dose level 1 of treatment. Part-2 of study (efficacy and safety evaluation) was not performed.

Participant milestones

Participant milestones
Measure	Aflibercept + XELOX (Oxaliplatin and Capecitabine) Aflibercept 6 mg/kg intravenous (IV) infusion every 3 weeks (q3w) in combination with Oxaliplatin 100 mg/m\^2 IV infusion q3w and Capecitabine 850 mg/m\^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Aflibercept as Maintenance Therapy Following Induction With Aflibercept in Combination With XELOX, as First-Line Treatment for Metastatic Colorectal Cancer Patient

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aflibercept + XELOX (Oxaliplatin and Capecitabine) n=4 Participants Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m\^2 IV infusion q3w and Capecitabine 850 mg/m\^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Cycle 1 (Up to 3 weeks)

Population: Evaluable DLT population defined as the subset of the whole part 1 participants that were exposed to at least 1 dose (even incomplete) of the study treatment and had a DLT assessment at Cycle 1.

Outcome measures

Outcome measures
Measure	Aflibercept + XELOX (Oxaliplatin and Capecitabine) n=4 Participants Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m\^2 IV infusion q3w and Capecitabine 850 mg/m\^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)	1 Participants

PRIMARY outcome

Timeframe: 6 months after the start of maintenance therapy.

Population: Due to premature recruitment discontinuation, none of the planned efficacy analyses was performed.

It describes the number of participants alive without progression at 6 months after the start of Aflibercept maintenance therapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and every 9 weeks up to DP (up to 15 months).

Population: Evaluable Population (EP) for tumor response was defined as a subset of ITT population (all participants who gave their informed consent and successfully registered into study) with measurable disease at study entry, who received at least 1 cycle of study treatment, with at least 1 post baseline tumor evaluation, except for early DP or death.

Tumor assessment was performed by abdomino-pelvic computed tomography scan or magnetic resonance imaging (MRI) and chest X-ray or chest CT-scan to assess the disease status at baseline and then every 9 weeks during study treatment up to DP. Target lesions were evaluated using response evaluation criteria in solid tumors (RECIST) version 1.1, wherein CR = disappearance of all target lesions; PR = 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD; PD =20% increase in the sum of the LD of target lesions taking as reference the smallest sum in the study and SD = small changes that did not meet above criteria.

Outcome measures

Outcome measures
Measure	Aflibercept + XELOX (Oxaliplatin and Capecitabine) n=4 Participants Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m\^2 IV infusion q3w and Capecitabine 850 mg/m\^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
Part 1: Number of Participants With Tumor Responses (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD]) CR	0 Participants
Part 1: Number of Participants With Tumor Responses (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD]) PR	1 Participants
Part 1: Number of Participants With Tumor Responses (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD]) PD	0 Participants
Part 1: Number of Participants With Tumor Responses (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD]) SD	3 Participants

SECONDARY outcome

Timeframe: From the date of enrollment up to the date of DP or death, whichever occurred first (up to 15 months).

Population: Due to premature recruitment discontinuation, none of the planned efficacy analyses was performed.

PFS was defined as the time interval from the date of registration into the study to the date of first observation of DP or death (due to any cause), whichever was first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of enrollment up to the date of death (up to 15 months).

Population: Due to premature recruitment discontinuation, none of the planned efficacy analyses was performed.

OS was defined as the time interval from the date of registration into the study to the date of death due to any cause. In the absence of confirmation of death, survival time was to be censored at the earliest between the last date the participant was known to be alive and the end of study date.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months after the last participant enrolled.

Population: Due to premature recruitment discontinuation, none of the planned efficacy analyses was performed.

Overall metastases resection rate was defined as the percentage of participants reaching an R0 metastases resection, defined as the complete absence of invasive carcinoma on histological examination at the time of definitive surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and every 9 weeks up to end of study completion (15 months).

Population: Due to premature recruitment discontinuation, none of the planned efficacy analyses was performed.

Tumor assessment was performed by abdomino-pelvic computed tomography scan or MRI and chest X-ray or chest CT-scan to assess the disease status at baseline and then every 9 weeks during study treatment up to DP. Target lesions were evaluated using RECIST version 1.1, wherein CR = disappearance of all target lesions; PR = 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (within 21 days before registration); Day 1/pre-dose of Cycle 1, 2 and 3 of induction phase and maintenance phase; 30 ± 3 days after the last aflibercept administration.

Population: Due to premature recruitment discontinuation, no samples had been collected and none of the planned efficacy/pharmacodynamic analyses was performed.

Blood and tumor samples were to be collected to evaluate the pharmacodynamic parameters including the assessment of the modulation of circulating analytes such as cytokines and angiogenic factors.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (within 21 days before registration); Day 1/pre-dose of Cycle 1, 2 and 3 of induction phase and maintenance phase; 30 ± 3 days after the last aflibercept administration.

Population: Due to premature recruitment discontinuation, no samples had been collected and none of the planned biomarker analyses was performed.

Blood and tumor samples were to be collected to evaluate proteomic biomarkers such as factors and receptors related to angiogenesis process, inflammation, and tumor progression.

Outcome measures

Outcome data not reported

Adverse Events

Aflibercept + XELOX (Oxaliplatin and Capecitabine)

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Aflibercept + XELOX (Oxaliplatin and Capecitabine) n=4 participants at risk Aflibercept 6 mg/kg intravenous(IV) infusion every 3 weeks (q3w) in combination with Oxaliplatin 100 mg/m\^2 IV infusion q3w and Capecitabine 850 mg/m\^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
Cardiac disorders Acute coronary syndrome	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
General disorders Fatigue	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Vascular disorders Hypertension	75.0% 3/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).

Other adverse events

Other adverse events
Measure	Aflibercept + XELOX (Oxaliplatin and Capecitabine) n=4 participants at risk Aflibercept 6 mg/kg intravenous(IV) infusion every 3 weeks (q3w) in combination with Oxaliplatin 100 mg/m\^2 IV infusion q3w and Capecitabine 850 mg/m\^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
Cardiac disorders Bradycardia	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Gastrointestinal disorders Abdominal pain	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Gastrointestinal disorders Constipation	50.0% 2/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Gastrointestinal disorders Diarrhoea	50.0% 2/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Gastrointestinal disorders Haemorrhoids	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Gastrointestinal disorders Nausea	50.0% 2/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Gastrointestinal disorders Stomatitis	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Gastrointestinal disorders Vomiting	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
General disorders Asthenia	50.0% 2/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
General disorders Chest pain	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
General disorders Fatigue	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
General disorders Localised oedema	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
General disorders Pyrexia	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Infections and infestations Device related infection	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Infections and infestations Pharyngitis	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Injury, poisoning and procedural complications Incisional hernia	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Investigations Weight decreased	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Investigations Weight increased	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Metabolism and nutrition disorders Decreased appetite	50.0% 2/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Metabolism and nutrition disorders Dehydration	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Musculoskeletal and connective tissue disorders Back pain	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Musculoskeletal and connective tissue disorders Flank pain	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Nervous system disorders Dysgeusia	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Nervous system disorders Headache	50.0% 2/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Nervous system disorders Paraesthesia	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Psychiatric disorders Depression	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Psychiatric disorders Insomnia	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Renal and urinary disorders Haematuria	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Renal and urinary disorders Hydronephrosis	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Renal and urinary disorders Proteinuria	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Respiratory, thoracic and mediastinal disorders Dysphonia	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Respiratory, thoracic and mediastinal disorders Hiccups	50.0% 2/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Vascular disorders Hypertension	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).
Vascular disorders Hypotension	25.0% 1/4 • All AEs were collected from signature of the informed consent form up to 30 days after the last administration of treatment regardless of seriousness or relationship to study treatment. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (from the first study treatment administration to 30 days after the last study treatment administration).

Additional Information

Trial Transparency Team

Sanofi

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Publication restrictions are in place

Restriction type: OTHER