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Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer

Primary Purpose

Metastatic Colorectal Cancer

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Sym004 (12 mg/kg)

Sym004 (9/6 mg/kg)

Best Supportive Care (BSC)

Fluorouracil (5-FU)

Capecitabine

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Metastatic Colorectal Cancer, Best Supportive Care, Capecitabine, Fluorouracil (5-FU), Sym004

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written informed consent obtained before undergoing any study-related activities
Male or female, at least 18 years of age
Subjects with histologically or cytologically confirmed mCRC, Kirsten rat sarcoma wild-type (KRAS WT) at initial diagnosis
Failure of or intolerance to 5-FU, Oxaliplatin, and Irinotecan
Acquired resistance to marketed anti-EGFR mAbs as defined in the protocol
Measurable disease defined as one or more target lesions according to RECIST
Life expectancy of at least 3 months
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
Other protocol defined inclusion criteria could apply

Exclusion Criteria:

Pretreatment with regorafenib.
Subjects who in the opinion of the subject and investigator would benefit more from regorafenib treatment (except where regorafenib is not reimbursed in the country)
Skin rash Common Terminology Criteria for AEs (CTCAE) Grade greater than 1 from previous anti-EGFR therapy at time of randomization
Magnesium less than 0.9 milligram per deciliter (mg/dL)
Known hypersensitivity to any of the treatment ingredients. Known previous Grade 3-4 infusion related reactions with anti-EGFR mABs
Other protocol defined exclusion criteria could apply

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: Sym004 (12 mg/kg)

Arm B: Sym004 (9/6 mg/kg)

Arm C: Investigator's Choice

Arm Description

Sym004 will be administered as an intravenous infusion at a dose of 12 milligrams per kilogram (mg/kg) weekly until unacceptable toxicity, disease progression, or consent withdrawal.

Sym004 will be administered as an intravenous infusion at a loading dose of 9 mg/kg followed by 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal.

Best supportive care (BSC) or Fluorouracil (5-FU) or Capecitabine will be given as per Investigator's discretion.

Outcomes

Primary Outcome Measures

Overall Survival (OS) Time

OS based on product-limit (Kaplan-Meier) estimates. Confidence intervals for the median are calculated according to Brookmeyer and Crowley. If a subject had not died, survival time was censored at the last date the subject was known to be alive.

Secondary Outcome Measures

Best Overall Response (OR) According to the Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1)

Tumor assessments were done via computed tomography (CT) or magnetic resonance imaging (MRI) scans and evaluated per RECIST v1.1. The assessment for measurable disease during screening (within 14 days prior to Day 1) acts as the baseline assessment. Best OR was summarized for each treatment group by means of counts and percentages for the following categories: Complete Response (CR: disappearance of all target lesions), Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions), Progressive Disease (PD: at least a 20% increase in the sum of diameters of target lesions), Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) or Not Evaluable (NE).

Progression Free Survival (PFS) Time

PFS based on product-limit (Kaplan-Meier) estimates. Confidence intervals for the median are calculated according to Brookmeyer and Crowley. Death will only be considered as an event if it occurs within 12 weeks after last tumor response assessment without progression.

Time to Treatment Failure (TTF)

TTF based on product-limit (Kaplan-Meier) estimates. Confidence intervals for the median are calculated according to Brookmeyer and Crowley.

Occurrence and Nature of Adverse Events (AEs), as Assessed by the Common Terminology Criteria for AEs (Version 4.03) (CTCAE v4.03).

AEs were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) classification. The incidence and type of AEs (i.e., serious AE [SAE], treatment-emergent AE [TEAE]) were summarized by dose cohort according to MedDRA system organ classes and preferred terms. An AE was considered as treatment-emergent if it occurred during or after the first IMP administration. An AE that occurred before the first IMP administration and worsened thereafter was also considered an AE. Worsening was reported as a new AE.

Relative Dose Intensity of Sym004

Treatment duration (weeks) is calculated as [(last dose date of Sym004 - first dose date of Sym004)+7] / 7 days. Sym004 dose received (mg/kg) is calculated as (total dose administered (mg)/weight (kg)). Dose Intensity is calculated as (cumulative Sym004 dose (mg/kg) / treatment duration (weeks)). Relative Dose Intensity is calculated as (dose intensity / planned dose intensity at randomization)*100. Percentages are based on the number of subjects in the safety analysis set.

Pharmacokinetic (PK) Parameters: Sym004 Concentrations

The Sym004 serum concentration used for the PK evaluation was calculated as the sum of the serum concentrations of the 2 component monoclonal antibodies of Sym004 (futuximab and modotuximab). Trough Concentration (Ctrough) is equivalent to the concentration collected at the pre-dose timepoint. Maximum Concentration (Cmax) is equivalent to the concentration collected at the end of infusion (EOI) timepoint.

Pharmacokinetic (PK) Parameters: Time of Maximum Plasma Concentration (Tmax)

Tmax was defined as the time the PK sample was taken at end of infusion (EOI) relative to the start time of infusion (i.e., time between the start of infusion and the time of the EOI sample). For presentation of individual PK parameters and calculation of mean parameters, half of the lower limit of quantitation (LLOQ) value was used for concentration values below the LLOQ. The Sym004 serum concentration used for the PK evaluation was calculated as the sum of the serum concentrations of the 2 component monoclonal antibodies of Sym004, futuximab and modotuximab.

Host Immune Response: Number of Subjects With Anti-drug Antibodies (ADAs) to Sym004 Over Time

A validated double antigen bridging ELISA was used for screening, confirmation, and titration of patient samples for anti-Sym004 ADA. Using rabbit anti-Sym004 as an ADA control antibody, the lower limit of detection was 54 ng/mL in the absence of Sym004 and 500 ng/mL in the presence of Sym004 at 5 µg/mL The timepoints for ADA sampling were chosen by the original sponsor for this trial. After the trial was transferred to Symphogen A/S, it was determined that not all samples were necessary for analysis. This is why the collection time points specified in the Outcome Measure Time Frame do not match with the Outcome Measure Data Table.

Quality of Life Assessed by the EORTC QLQ-C30 (Version 3)

Scale: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (Version 3) [QLQ-C30, Version 3]. The QLQ-C30 is a 30-question scale used to assess cancer patients' quality of life based on 15 factors (e.g., global health status, physical functioning, role functioning, etc.). The scale is composed of both multi-item scales and single-item measures. All of the scales and single-item measures range in score from 0 to 100: A high score for a functional scale represents a healthy level of functioning. A high score for the global health status represents a high quality of life. A high score for a symptom scale/item represents a high level of symptomatology (problems).

Quality of Life Assessed by EORTC QLQ-CR29

Scale: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Colorectal Cancer Module (QLQ-CR29). The QLQ-CR29 is a 29-question scale used to assess colorectal cancer patients' quality of life based on 22 factors (e.g., body image, anxiety, weight, etc.). The scale is composed of both multi-item scales and single-item measures. All of the scales and single-item measures range in score from 0 to 100: A high score for a functional scale/item represents an unhealthy level of functioning, with the exception of one (1) scale pertaining to sexual interest (separated by sex). A high score for a symptom scale/item represents a high level of symptomatology (problems).

Quality of Life Assessed by FACT-EGFRI-18 for Skin Rash

Scale: Functional Assessment of Cancer Therapy-Epidermal Growth Factor Receptor Inhibitor 18 (FACT-EGFRI-18). The FACT-EGFRI-18 is an 18-question scale used to assess EGFR-inhibitor-treated cancer patients' quality of life relative to their experience of skin rash based on three (3) multi-item subscales. The subscales combined (i.e., Symptom Index) range in score from 0 to 72. A higher score represents a high level of symptomatology (problems). High scores for all subscales represent a worse outcome: The Physical subscale ranges in score from 0 to 28. The Social/Emotional subscale ranges in score from 0 to 24. The Functional subscale ranges in score from 0 to 20.

Full Information

NCT ID

NCT02083653

First Posted

March 7, 2014

Last Updated

April 9, 2019

Sponsor

Symphogen A/S

1. Study Identification

Unique Protocol Identification Number

NCT02083653

Brief Title

Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer

Official Title

Open-label, Randomized, Controlled, Multicenter Phase II Trial Investigating 2 Sym004 Doses Versus Investigator's Choice (Best Supportive Care, Capecitabine, 5-FU) in Subjects With Metastatic Colorectal Cancer and Acquired Resistance to Anti-EGFR Monoclonal Antibodies

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

March 6, 2014 (Actual)

Primary Completion Date

October 24, 2016 (Actual)

Study Completion Date

April 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Symphogen A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a Phase 2, open-label, randomized, 3-arm trial investigating the efficacy of two Sym004 doses (Arm A and Arm B) compared with a control group (Arm C) in subjects with metastatic colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs).

Detailed Description

This trial assesses the efficacy of two different weekly dosing regimens of Sym004 (Arm A: 12 mg/kg/week versus Arm B: 9 mg/kg loading dose followed by 6 mg/kg/week) compared with investigator's choice in terms of overall survival time in subjects with mCRC. Subjects assigned to Arm C will receive best supportive care (BSC), Fluorouracil (5-FU), or Capecitabine, per local standard of care. Subjects will receive treatment until unacceptable toxicity, disease progression, withdrawal of consent, or until the subject meets any of the criteria for treatment discontinuation or trial discontinuation. Therefore, the duration of treatment will differ among individuals and cannot be fixed in advance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Colorectal Cancer

Keywords

Metastatic Colorectal Cancer, Best Supportive Care, Capecitabine, Fluorouracil (5-FU), Sym004

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

254 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A: Sym004 (12 mg/kg)

Arm Type

Experimental

Arm Description

Sym004 will be administered as an intravenous infusion at a dose of 12 milligrams per kilogram (mg/kg) weekly until unacceptable toxicity, disease progression, or consent withdrawal.

Arm Title

Arm B: Sym004 (9/6 mg/kg)

Arm Type

Experimental

Arm Description

Sym004 will be administered as an intravenous infusion at a loading dose of 9 mg/kg followed by 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal.

Arm Title

Arm C: Investigator's Choice

Arm Type

Active Comparator

Arm Description

Best supportive care (BSC) or Fluorouracil (5-FU) or Capecitabine will be given as per Investigator's discretion.

Intervention Type

Drug

Intervention Name(s)

Sym004 (12 mg/kg)

Intervention Description

Sym004 is a 1:1 mixture of two mAbs (futuximab and modotuximab) which bind to two non-overlapping epitopes of the EGFR.

Intervention Type

Drug

Intervention Name(s)

Sym004 (9/6 mg/kg)

Intervention Description

Sym004 is a 1:1 mixture of two mAbs (futuximab and modotuximab) which bind to two non-overlapping epitopes of the EGFR.

Intervention Type

Other

Intervention Name(s)

Best Supportive Care (BSC)

Intervention Description

BSC is the best palliative care as per Investigator's discretion, excluding antineoplastic agents. BSC may include, but is not limited to, antibiotics, analgesics, antiemetics, blood transfusions, and nutritional support.

Intervention Type

Drug

Intervention Name(s)

Fluorouracil (5-FU)

Other Intervention Name(s)

Adrucil

Intervention Description

5-FU will be administered at doses and schedules as per Investigator's discretion and in line with the local package insert.

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Other Intervention Name(s)

Xeloda

Intervention Description

Capecitabine will be administered at doses and schedules as per Investigator's discretion and in line with the local package insert.

Primary Outcome Measure Information:

Title

Overall Survival (OS) Time

Description

Time Frame

From randomization until the date of death (assessed up to 32 months).

Secondary Outcome Measure Information:

Title

Best Overall Response (OR) According to the Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1)

Description

Time Frame

From randomization until first radiological confirmed or clinical progression event, or death due to any cause, within 12 weeks after last tumor assessment (assessed up to 32 months).

Title

Progression Free Survival (PFS) Time

Description

Time Frame

From randomization until first event, where an event can be a progression (radiological confirmed or clinical progression) or death due to any cause (assessed up to 32 months).

Title

Time to Treatment Failure (TTF)

Description

TTF based on product-limit (Kaplan-Meier) estimates. Confidence intervals for the median are calculated according to Brookmeyer and Crowley.

Time Frame

From randomization until treatment discontinuation for any reason, including disease progression or death (assessed up to 32 months).

Title

Occurrence and Nature of Adverse Events (AEs), as Assessed by the Common Terminology Criteria for AEs (Version 4.03) (CTCAE v4.03).

Description

Time Frame

From Baseline up to 28 days after the last IMP administration.

Title

Relative Dose Intensity of Sym004

Description

Time Frame

From first dose of study drug until disease progression (assessed up to 32 months).

Title

Pharmacokinetic (PK) Parameters: Sym004 Concentrations

Description

Time Frame

Weeks 3, 5, and 7 and at the End of Treatment visit, including a Week 1 and Week 2 subset.

Title

Pharmacokinetic (PK) Parameters: Time of Maximum Plasma Concentration (Tmax)

Description

Time Frame

Day 1 on Weeks 1-3 followed by Week 5 Day 1 and Week 7 Day 1.

Title

Host Immune Response: Number of Subjects With Anti-drug Antibodies (ADAs) to Sym004 Over Time

Description

Time Frame

Every two weeks (Days 15, 29, and 43) followed by every six weeks thereafter (Days 78, 120, 162, etc.) until the End of Treatment Visit

Title

Quality of Life Assessed by the EORTC QLQ-C30 (Version 3)

Description

Time Frame

Assessed every 6 weeks (week 1 and week 7 reported)

Title

Quality of Life Assessed by EORTC QLQ-CR29

Description

Time Frame

Assessed every 6 weeks (week 1 and week 7 reported)

Title

Quality of Life Assessed by FACT-EGFRI-18 for Skin Rash

Description

Time Frame

Assessed every 3 weeks (week 1 and week 4 reported)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent obtained before undergoing any study-related activities Male or female, at least 18 years of age Subjects with histologically or cytologically confirmed mCRC, Kirsten rat sarcoma wild-type (KRAS WT) at initial diagnosis Failure of or intolerance to 5-FU, Oxaliplatin, and Irinotecan Acquired resistance to marketed anti-EGFR mAbs as defined in the protocol Measurable disease defined as one or more target lesions according to RECIST Life expectancy of at least 3 months Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1 Other protocol defined inclusion criteria could apply Exclusion Criteria: Pretreatment with regorafenib. Subjects who in the opinion of the subject and investigator would benefit more from regorafenib treatment (except where regorafenib is not reimbursed in the country) Skin rash Common Terminology Criteria for AEs (CTCAE) Grade greater than 1 from previous anti-EGFR therapy at time of randomization Magnesium less than 0.9 milligram per deciliter (mg/dL) Known hypersensitivity to any of the treatment ingredients. Known previous Grade 3-4 infusion related reactions with anti-EGFR mABs Other protocol defined exclusion criteria could apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Josep Tabernero, MD, PhD

Organizational Affiliation

Vall d'Hebron University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

USC Norris Comprehensive Cancer Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

Sharp Memorial Hospital

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Florida Cancer Specialists-Broadway

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33916

Country

United States

Facility Name

Hematology - Oncology Associates of Treasure Coast

City

Port Saint Lucie

State/Province

Florida

ZIP/Postal Code

34952

Country

United States

Facility Name

Florida Cancer Specialists

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33705

Country

United States

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Mercy Research

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65807

Country

United States

Facility Name

Comprehensive Cancer Centers of Nevada

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89074

Country

United States

Facility Name

Texas Oncology, P.A.

City

Tyler

State/Province

Texas

ZIP/Postal Code

75702

Country

United States

Facility Name

SMZ Süd - Kaiser Franz Josef Spital Wien

City

Wien

ZIP/Postal Code

1100

Country

Austria

Facility Name

ULB Hôpital Erasme

City

Bruxelles

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Cliniques Universitaires Saint-Luc

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Universitair Ziekenhuis Gent

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

UZ Leuven

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

CHU Ambroise Paré

City

Mons

ZIP/Postal Code

7000

Country

Belgium

Facility Name

Clinique et Maternité Sainte-Elisabeth

City

Namur

ZIP/Postal Code

5000

Country

Belgium

Facility Name

CHU Mont-Godinne

City

Yvoir

ZIP/Postal Code

5530

Country

Belgium

Facility Name

ICO - Site Paul Papin

City

Angers Cedex 9

ZIP/Postal Code

49933

Country

France

Facility Name

Institut Sainte Catherine

City

Avignon

ZIP/Postal Code

84000

Country

France

Facility Name

Groupe Hospitalier Saint André - Hôpital Saint André

City

Bordeaux Cedex

ZIP/Postal Code

33075

Country

France

Facility Name

Centre Georges François Leclerc

City

Dijon Cedex

ZIP/Postal Code

21079

Country

France

Facility Name

Centre Léon Bérard

City

Lyon

ZIP/Postal Code

69008

Country

France

Facility Name

CRLCC Eugene Marquis

City

Rennes Cedex

ZIP/Postal Code

35042

Country

France

Facility Name

ICO - Site René Gauducheau

City

Saint Herblain

ZIP/Postal Code

44805

Country

France

Facility Name

CHU de Toulouse - Hôpital Rangueil

City

Toulouse Cedex 9

ZIP/Postal Code

31059

Country

France

Facility Name

Universitaetsklinikum Carl Gustav Carus TU Dresden

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Klinikum der Johann Wolfgang Goethe-Universitaet

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Uzsoki Utcai Korhaz

City

Budapest

ZIP/Postal Code

1145

Country

Hungary

Facility Name

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

City

Miskolc

ZIP/Postal Code

3526

Country

Hungary

Facility Name

SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

City

Nyiregyhaza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

Jasz-Nagykun-Szolnok Megyei Korhaz-Rendelointezet

City

Szolnok

ZIP/Postal Code

5000

Country

Hungary

Facility Name

Azienda Ospedaliero Universitaria Ospedali Riuniti

City

Ancona

ZIP/Postal Code

60126

Country

Italy

Facility Name

Azienda Ospedaliero Universitaria San Martino

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Azienda Ospedaliera Ospedale Niguarda Ca' Granda

City

Milano

ZIP/Postal Code

20162

Country

Italy

Facility Name

Seconda Università degli Studi di Napoli

City

Napoli

ZIP/Postal Code

80138

Country

Italy

Facility Name

IOV - Istituto Oncologico Veneto IRCCS

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Azienda Ospedaliero Universitaria Pisana

City

Pisa

ZIP/Postal Code

56126

Country

Italy

Facility Name

Policlinico Universitario Agostino Gemelli

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

Presidio Ospedaliero SS. Trinità Sora

City

Sora

ZIP/Postal Code

03039

Country

Italy

Facility Name

Azienda Ospedaliera S. Maria Di Terni

City

Terni

ZIP/Postal Code

05100

Country

Italy

Facility Name

SPZOZ MSW zWarmińsko-MazurskimCen.Onko.wOlsztynie

City

Olsztyn

ZIP/Postal Code

10-228

Country

Poland

Facility Name

Wielkopolskie Centrum Onkologii

City

Poznan

ZIP/Postal Code

61-866

Country

Poland

Facility Name

Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

BHI of Omsk region "Clinical Oncology Dispensary"

City

Omsk

ZIP/Postal Code

644013

Country

Russian Federation

Facility Name

St. Petersburg SHI "City Clinical Oncology Dispensary"

City

St. Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Hospital del Mar

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Hospital Universitari Vall d'Hebron

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Hospital Clinic i Provincial de Barcelona

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

ICO l´Hospitalet - Hospital Duran i Reynals

City

Barcelona

ZIP/Postal Code

08908

Country

Spain

Facility Name

Hospital General Universitario Gregorio Marañon

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Centro Integral Oncologico Clara Campal

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

Hospital Universitario Central de Asturias

City

Oviedo

ZIP/Postal Code

33006

Country

Spain

Facility Name

Hospital Universitario Virgen del Rocio

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

8433390

Citation

Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

Results Reference

background

Citation

Fayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A, on behalf of the EORTC Quality of Life Group. The EORTC QLQ-C30 Scoring Manual (3rd Edition). Published by: European Organisation for Research and Treatment of Cancer, Brussels 2001.

Results Reference

background

Learn more about this trial

Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer

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Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer

Metastatic Colorectal Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial