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Center for Global Research Data

Summarising the therapeutic and adverse effects of anticancer medicines according to race and sex: pooled analysis of clinical trials of contemporary treatments for solid tumours

Lead Investigator: Ashley Hopkins, Flinders University
Title of Proposal Research: Summarising the therapeutic and adverse effects of anticancer medicines according to race and sex: pooled analysis of clinical trials of contemporary treatments for solid tumours
Vivli Data Request: 7667
Funding Source: Flinders University
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Over the last decade there has been substantial advancement in the treatment of solid tumours (e.g., lung, breast, colorectal, prostate cancer), including the introduction of immune checkpoint inhibitors (a type of anticancer medicines), targeted therapies, and novel chemotherapies. However, response and toxicity to many of these medicines remains highly unpredictable. Two factors urgently requiring investigation are potential differences in therapeutic and adverse effects of contemporary anticancer medicines according to race and sex.

Race differences are associated with a significant health disparity gap. For many common malignancies there are substantial differences in incidences according to race, while race is a phenotype for differences in genetic and tumour biology factors. Further there are inequities in drug development processes (e.g., in reporting and representation) and it is unclear if this is resulting in systematic disparities in anticancer treatment therapeutic and adverse effects. Science is also becoming increasingly aware that sex is an important modifier of health, disease and medicine efficacy; however, the availability of quality information to inform sex (or gender) differences in outcomes from anticancer medicines are currently limited. This project will bring together individual participant data from key clinical trials to summarise the therapeutic and adverse effects of contemporary anticancer medicines according to race and sex. Being able to appraise the expected response and adverse effect profile of anticancer treatments according to racial and sex differences will enable patients and clinicians to make better patient-centred decisions.

Specifically, this project will endeavour to gather and then utilise data available via AstraZeneca, Bayer, Boehringer Ingelheim, Daiichi Sankyo, Eisai, Eli Lilly, Roche, Janssen, EMD Serono, Merck Sharp & Dohme, Novartis, Pfizer, Puma Biotechnology, Regeneron, Sanofi and Takeda’s data sharing policies to summarise the therapeutic and adverse effects of contemporary anticancer medicines according to race and sex.

Requested Studies:

AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
Data Contributor: AstraZeneca
Study ID: NCT02296125

AZD9291 (Osimertinib) Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Data Contributor: AstraZeneca
Study ID: NCT02151981

LUX Lung 2 A Phase II Single-arm Trial of BIBW 2992 in Non-small Cell Lung Cancer Patients With EGFR Activating Mutations
Data Contributor: Boehringer Ingelheim
Study ID: NCT00525148
Sponsor ID: 1200.22

LUX-Lung 6: A Randomized, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation
Data Contributor: Boehringer Ingelheim
Study ID: NCT01121393
Sponsor ID: 1200.34

A Randomised, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation
Data Contributor: Boehringer Ingelheim
Study ID: NCT00949650
Sponsor ID: 1200.32

LUX-Lung 8: A Randomized, Open-label Phase III Trial of Afatinib Versus Erlotinib in Patients With Advanced Squamous Cell Carcinoma of the Lung as Second-line Therapy Following First-line Platinum-based Chemotherapy
Data Contributor: Boehringer Ingelheim
Study ID: NCT01523587
Sponsor ID: 1200.125

A Double-blind, Randomized, Placebo-controlled Phase 3 Study of Orally Administered PLX3397 in Subjects With Pigmented Villonodular Synovitis or Giant Cell Tumor of the Tendon Sheath
Data Contributor: Daiichi Sankyo, Inc.
Study ID: NCT02371369
Sponsor ID: PLX108-10

A Phase 2, Multicenter, Open-Label Study of DS-8201a, an Anti-HER2-Antibody Drug Conjugate (ADC) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1 (DESTINY-Breast01)
Data Contributor: Daiichi Sankyo, Inc.
Study ID: NCT03248492
Sponsor ID: DS8201-A-U201

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) Drug Product in Patients With Metastatic Gastric Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine
Data Contributor: Lilly
Study ID: NCT01170663
Sponsor ID: 13894

A Randomized, Double-Blind, Phase 3 Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression After One Prior Platinum-Based Therapy
Data Contributor: Lilly
Study ID: NCT01168973
Sponsor ID: 13852

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) Plus LY2835219, a CDK4/6 Inhibitor, or Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer With No Prior Systemic Therapy in This Disease Setting
Data Contributor: Lilly
Study ID: NCT02246621
Sponsor ID: 15417

A Phase 3, Randomized, Double-Blinded Study of IMC-1121B and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Following Disease Progression on First-Line Platinum- or Fluoropyrimidine-Containing Combination Therapy
Data Contributor: Lilly
Study ID: NCT00917384
Sponsor ID: 13893

A Randomized, Double-blind, Multicenter Phase 3 Study of Irinotecan, Folinic Acid, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab or Placebo in Patients With Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy With Bevacizumab, Oxaliplatin, and a Fluoropyrimidine
Data Contributor: Lilly
Study ID: NCT01183780
Sponsor ID: 13856

A Randomized, Multicenter, Open-Label Phase 3 Study of Pemetrexed-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Pemetrexed-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Nonsquamous Non-Small Cell Lung Cancer (NSCLC)
Data Contributor: Lilly
Study ID: NCT00982111
Sponsor ID: 13908

A Randomized, Multicenter, Open-Label Phase 3 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Gemcitabine-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)
Data Contributor: Lilly
Study ID: NCT00981058
Sponsor ID: 13909

A Phase 2 Study of LY2835219 for Patients With Previously Treated Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
PI Data Contributor: Lilly
Study ID: NCT02102490
Sponsor ID: 15419

MONARCH 2: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without Abemaciclib, a CDK4/6 Inhibitor, for Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer
Data Contributor: Lilly
Study ID: NCT02107703
Sponsor ID: 15362

A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer
Data Contributor: Roche
Study ID: NCT00567190
Sponsor ID: TOC4129g

A Randomised, Multicentre, Multinational Phase II Study to Evaluate Pertuzumab in Combination With Trastuzumab, Given Either Concomitantly or Sequentially With Standard Anthracycline-based Chemotherapy or Concomitantly With a Non-anthracycline-based Chemotherapy Regimen, as Neoadjuvant Therapy for Patients With Locally Advanced, Inflammatory or Early Stage HER2-positive Breast Cancer
Data Contributor: Roche
Study ID: NCT00976989
Sponsor ID: BO22280

A Randomized, Open Label Study to Compare the Complete Pathological Response Rate Achieved With 4 Combinations of Herceptin, Docetaxel and Pertuzumab in Patients With Locally Advanced, Inflammatory or Early Stage HER2 Positive Breast Cancer
Data Contributor: Roche
Study ID: NCT00545688
Sponsor ID: WO20697

A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer
Data Contributor: Roche
Study ID: NCT01358877
Sponsor ID: BO25126

A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy
Data Contributor: Roche
Study ID: NCT01772472
Sponsor ID: BO27938

A Phase III Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Nab-Paclitaxel for Chemotherapy-Naive Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02367781
Sponsor ID: GO29537

Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02075840
Sponsor ID: BO28984

A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel With or Without Bevacizumab Compared With Carboplatin + Paclitaxel + Bevacizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02366143
Sponsor ID: GO29436

A Phase III, Double-Blind, Placebo-Controlled Study of Vemurafenib Versus Vemurafenib Plus GDC-0973 in Previously Untreated BRAF^600-Mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma
Data Contributor: Roche
Study ID: NCT01689519
Sponsor ID: GO28141

A Phase II, Multicenter, Single-Arm Study of Atezolizumab in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
Data Contributor: Roche
Study ID: NCT02951767
Sponsor ID: GO29293 (Cohort 1)

A Phase I/III, Randomized, Double-Blind, Placebo-Controlled Study of Carboplatin Plus Etoposide With or Without Atezolizumab (Anti-PD-L1 Antibody) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02763579
Sponsor ID: GO30081

A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure With Platinum Containing Chemotherapy
Data Contributor: Roche
Study ID: NCT02008227
Sponsor ID: GO28915

A Randomized, Multicenter, Phase III Open-label Study of the Efficacy and Safety of Trastuzumab MCC-DM1 vs. Capecitabine + Lapatinib in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy
Data Contributor: Roche
Study ID: NCT00829166
Sponsor ID: BO21977

A Phase III, Open-Label, Randomized Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
Data Contributor: Roche
Study ID: NCT03434379
Sponsor ID: YO40245

A Phase III, Double-Blinded, Randomized, Placebo-Controlled Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFV600 Mutation-Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma
Data Contributor: Roche
Study ID: NCT02908672
Sponsor ID: CO39262

A Pivotal Phase II, Multicenter, Single-arm, Two-cohort Trial Evaluating the Efficacy and Safety of GDC-0449 in Patients With Advanced Basal Cell Carcinoma
Data Contributor: Roche
Study ID: NCT00833417
Sponsor ID: SHH4476g

BRIM 3: A Randomized, Open-Label, Controlled, Multicenter, Phase III Study in Previously Untreated Patients With Unresectable Stage IIIC or Stage IV Melanoma With V600E BRAF Mutation Receiving Vemurafenib (RO5185426) or Dacarbazine
Data Contributor: Roche
Study ID: NCT01006980
Sponsor ID: NO25026

An Open-label Multicenter Study on the Efficacy of Continuous Oral Dosing of Vemurafenib on Tumour Response in Previously Treated Patients With Metastatic Melanoma
Data Contributor: Roche
Study ID: NCT00949702
Sponsor ID: NP22657

An Open-label, Single-arm, Phase II, Multicenter Study, to Evaluate the Efficacy of Vemurafenib in Metastatic Melanoma Patients With Brain Metastases
Data Contributor: Roche
Study ID: NCT01378975
Sponsor ID: MO25743

A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 3 STUDY OF PD-0332991 (ORAL CDK 4/6 INHIBITOR) PLUS LETROZOLE VERSUS PLACEBO PLUS LETROZOLE FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH ER (+), HER2 (-) BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI CANCER TREATMENT FOR ADVANCED DISEASE
Data Contributor: Pfizer Inc.
Study ID: NCT01740427
Sponsor ID: A5481008

MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 3 TRIAL OF FULVESTRANT (FASLODEX (REGISTERED)). WITH OR WITHOUT PD-0332991 (PALBOCICLIB) +/- GOSERELIN IN WOMEN WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR ENDOCRINE THERAPY
Data Contributor: Pfizer Inc.
Study ID: NCT01942135
Sponsor ID: A5481023

AXITINIB (AG-013736) AS SECOND LINE THERAPY FOR METASTATIC RENAL CELL CANCER: AXIS TRIAL
Data Contributor: Pfizer Inc.
Study ID: NCT00678392
Sponsor ID: A4061032

An International, Phase III, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study to Assess the Efficacy of ZD6474 (ZACTIMATM) Versus Placebo in Subjects With Unresectable Locally Advanced or Metastatic Medullary Thyroid Cancer
Data Contributor: Sanofi
Study ID: NCT00410761
Sponsor ID: D4200C00058

A Phase 3 Multicenter Open-label Study of Brigatinib (AP26113) Versus Crizotinib in Patients With ALK-positive Advanced Lung Cancer
Data Contributor: Takeda
Study ID: NCT02737501
Sponsor ID: AP26113-13-301

A Randomized Phase 2 Study of AP26113 in Patients With ALK-positive, Non-small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib
Data Contributor: Takeda
Study ID: NCT02094573
Sponsor ID: AP26113-13-201

A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations
Data Contributor: Pfizer Inc.
Study ID: NCT01970865

Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer
Data Contributor: Pfizer Inc.
Study ID: NCT02928224

A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung
Data Contributor: Pfizer Inc.
Study ID: NCT01154140

An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene
Data Contributor: Pfizer Inc.
Study ID: NCT00932893

Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma
Data Contributor: Pfizer Inc.
Study ID: NCT01909453

ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC.
Data Contributor: Pfizer Inc.
Study ID: NCT01774721

A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)
Data Contributor: Pfizer Inc.
Study ID: NCT02603432

A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)
Data Contributor: Pfizer Inc.
Study ID: NCT01945775

Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen
Data Contributor: Sanofi
Study ID: NCT00561470

A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)
Data Contributor: Johnson & Johnson
Study ID: NCT01715285
Sponsor ID: CR100900

A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
Data Contributor: Johnson & Johnson
Study ID: NCT00887198
Sponsor ID: CR016927

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy
Data Contributor: Johnson & Johnson
Study ID: NCT00638690
Sponsor ID: CR016924

A Randomized Controlled Study of YONDELIS (Trabectedin) or Dacarbazine for the Treatment of Advanced Liposarcoma or Leiomyosarcoma
Data Contributor: Johnson & Johnson
Study ID: NCT01343277
Sponsor ID: CR018004

Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2Mutations.
Data Contributor: AstraZeneca
Study ID: NCT02000622

Assessment of Efficacy of AZD2281 in Platinum Sensitive Relapsed Serous Ovarian Cancer
Data Contributor: AstraZeneca
Study ID: NCT00753545

Open Label Study to Assess Efficacy and Safety of Olaparib in Confirmed Genetic BRCA1 orBRCA2 Mutation Pats
Data Contributor: AstraZeneca
Study ID: NCT01078662

Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy
Data Contributor: AstraZeneca
Study ID: NCT01874353