Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Trastuzumab

Immunoglobulins

Lapatinib

Protein Kinase Inhibitors

Joaquin Gávila, MD

A retrospective, observational, not EPA, multicenter study to evaluate the Clinical Benefit of Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib between January 2005 and December 2011

Clinical Benefit of the Treatment With Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib

Observational, Retrospective and Multicenter Study to Evaluate the Clinical Benefit of Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib

clinical benefit rate (CBR): defined as the percentage of patients who achieved an objective response (CR or PR) or tumor stabilization for at least 24 weeks or more during the period of treatment with the combination TL.

This variable will be assessed by RECIST v 1.1

The progression will be evaluated by RECIST v 1.1.

clinical benefit: defined as reaching a (complete or partial) objective response or stabilization of tumor for more than 24 weeks

Adverse reactions observed during treatment of the combination TL, measured with scale CTCAE v.4

MedSIR

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Fibrinolytic Agents

Anticoagulants

Heparin, Low-Molecular-Weight

Tinzaparin

Dalteparin

Heparin

Calcium heparin

50, 100, 150 IU/kg administered subcutaneously once daily for 3 cycles of chemotherapy

dalteparin

Laurie Elit, MD

Agnes Lee, MD

Mark Levine, MD

Jim Julian, MMath

Epithelial ovarian carcinoma (EOC) is the 5th leading cause of death among women. Long-term survival is poor for the majority of women with EOC because many present with advanced disease. Chemotherapy and cytoreductive surgery produces a 50% - 60% response rate but relapse is not uncommon. Adding more systemic agents has failed to show a clear benefit in survival and is associated with unacceptable toxicity. This phase II, dose-finding, open label trial will enrol women with newly diagnosed EOC and randomize them to receive one of 3 doses of a LMWH dalteparin in conjunction with standard adjuvant taxane- and platinum-based chemotherapy. The primary outcome is disease response, measured according to Gynaecologic Cancer Intergroup (GCIG) Cancer Antigen (CA)-125 response criteria. Secondary outcomes include symptomatic venous thromboembolism, bleeding, and compliance. The dose of dalteparin associated with the best response will be tested further in a phase III randomized clinical trial in the same patient population.

Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)

A Phase II Randomized Study of Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)

Pfizer

Ontario Clinical Oncology Group (OCOG)

Dr. Mark Levine

Immunomodulating Agents

Immunologic Factors

ADC-1013 (agonistic human monoclonal IgG1 anti-CD40 antibody) administered by intratumoral injection every second week for 8 weeks. Patients that do not progress will be offered continued treatment until complete response, confirmed progressive disease, or clinical deterioration.

ADC-1013 (agonistic human monoclonal IgG1 anti-CD40 antibody) administered by intravenous infusion every second week until complete response, confirmed progressive disease, or clinical deterioration.

Agonistic human monoclonal IgG1 anti-CD40 antibody

ADC-1013

Per Norlén, MD, PhD

Dorte Nielsen, MD, PhD

The purpose of this study is to determine whether ADC-1013 (an agonistic human monoclonal IgG1 anti-CD40 antibody) is safe and tolerable when administered intratumorally (as repeated injections directly into the tumor tissue) or intravenously (as repeated doses directly into a vein) in patients with advanced solid tumors.

ADC-1013 First-in-Human Study

A First-in-human, Multicenter, Open-label, Multiple Ascending Dose Phase I Study in Patients With Advanced Solid Tumors to Determine the Safety, Pharmacokinetics and Pharmacodynamics of Intratumorally or Intravenously Administered ADC-1013

Dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and recommended Phase 2 dose of ADC-1013 administered intratumorally or intravenously will be defined.

Alligator Bioscience AB

Blood and Lymph Conditions

Immune System Diseases

Prostatic Neoplasms

Lymphoma

Melanoma

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Genital Neoplasms, Male

Genital Diseases, Male

Prostatic Diseases

Male Urogenital Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Lymphosarcoma

Neuroendocrine Tumor

Neuroepithelioma

PNT2258 is composed of PNT100, a 24-mer oligonucleotide, the active drug substance encapsulated in a liposome.

Patients will receive PNT2258 as an intravenous infusion once daily for 5 consecutive days (Days 1-5) of every 21-day cycle (3 weeks). The treatment cycle repeats every 3 weeks for up to 6 cycles in the absence of disease progression, unacceptable toxicity, or patient withdrawal from the study.

PNT2258

Anthony W Tolcher, MD, FRCP(C)

This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. The purpose of this research study is to evaluate the safety of the investigational drug PNT2258 in patients with advance tumors and see how it acts in the body.

This study is an open-label, single-arm, Phase 1 dose-escalation study of PNT2258 in patients with advanced solid tumors for which no standard therapy exists. Patients will receive PNT2258 as an intravenous infusion once daily for 5 consecutive days (Days 1-5) of every 21-day cycle (3 weeks). At first, patients will be treated in single patient cohorts following an accelerated titration design and evaluated for toxicities. After the accelerated portion ends, patients will be treated in cohorts of at least 3 patients at each dose level and evaluated for treatment-related toxicities.

A Study of PNT2258 in Patients With Advanced Solid Tumors

A Phase 1 Study of PNT2258 in Patients With Advanced Solid Tumors

Safety and tolerability of PNT2258 and the determination of dose-limiting toxicities (DLTs) and the recommended Phase 2 dose

Sierra Oncology LLC - a GSK company

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Amino Acids

Erlotinib Hydrochloride

Efatutazone

Tyrosine Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Drug: CS-7017 from 0.25 mg to 0.50 mg twice a daily Drug: Erlotinib 150 mg once daily

CS-7017 from 0.25 mg to 0.50 mg twice daily

CS-7017

Erlotinib

Global Clinical Leader

The primary objectives of this study are to evaluate the safety and tolerability of CS-7017 administered orally twice a day in combination with erlotinib, and to assess the pharmacokinetics of CS-7017 in combination with erlotinib.

CS-7017 in Combination With Erlotinib in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC)

Phase 1b Study of CS-7017 in Combination With Erlotinib in Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the drug treatment or any event already present that worsens in either intensity or frequency following exposure to the drug treatment. A CS-7017-related TEAE is an TEAE that is related to CS7017 in the relationship.

After the first CS-7017 administration, area under the concentration-time curve from zero to the last quantifiable concentration (AUClast) and area under the concentration-time curve during dosing interval (AUCtau) were assessed.

After the first CS-7017 administration, observed serum concentration (Cmax) and observed serum concentration at steady state (Cmax,ss) were assessed.

After the first CS-7017 administration, time of maximum plasma concentration (Tmax) and time of maximum plasma concentration at steady state (Tmax,ss) were assessed.

As per Response Evaluation Criteria for Solid Tumors v1.1, best overall response was characterized as complete response (CR) defined as disappearance of all target lesions, partial response (PR) defined as

≥30% decrease in the sum of diameters of target lesions, progressive disease (PD) defined as ≥20% increase in the sum of diameters of target lesions, and stable disease (SD) defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Response rate was defined as CR + PR.

Progression-free survival (PFS) was defined as the time from randomization to the date of the first objective documentation of progressive disease (PD) or death resulting from any cause, whichever came first.

A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the drug treatment or any event already present that worsens in either intensity or frequency following exposure to the drug treatment. An erlotinib-related TEAE is an TEAE that is related to erlotinib in the relationship

ICON Clinical Research

Daiichi Sankyo Co., Ltd.

Adverse events (AEs) were defined as any untoward, unfavorable, unintended medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All-cause mortality includes all deaths that occurred during the study and within 30 days after the last dose of study drug.

Participants who received oral CS-7017 0.25 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.

CS-7017 0.25 mg BID; Initial Portion

Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily.

CS-7017 0.50 mg BID; Initial Portion

CS-7017 0.50 mg BID; Additional Portion

Participants who received oral CS-7017 0.50 mg twice daily (BID) in combination with erlotinib 150 mg administered once daily (combined initial and additional portions).

CS-7017 0.50 mg BID; Initial + Additional Portions

All participants who received CS-71017 in combination with erlotinib.

Overall

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

South Korea

Region of Enrollment

Baseline characteristics are reported for participants in the Safety Analysis Set.

Contact for Clinical Trial Information

At least one CS-7017-Relaed TEAE

Blood and Lymphatic System Disorders

Anaemia

Thrombocytopenia

Neutropenia

Metabolism and Nutrition Disorders

Decreased appetite

Hypokalaemia

Hyponatraemia

Eye Disorders

Conjunctival hyperaemia

Cardiac Disorders

Pericardial effusion

Sinus arrhythmia

Respiratory, Thoracic, and Mediastinal Disorders

Pleural effusion

Gastrointestinal Disorders

Nausea

Renal and Urinary Disorders

Azotaemia

Congenital, Familial, and Genetic Disorders

Hydrocele

General Disorders & Administration Site Conditions

Face oedema

Oedema peripheral

Fatigue

Generalised oedema

Malaise

Investigations

Weight increased

Blood creatinine increased

Blood creatinine phosphokinase increased

Brain natriuretic peptide increased

Electrocardiogram QT prolonged

CS-7017-related TEAEs were assessed in the Safety Analysis Set.

CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy

Cycle 1, Week 1: AUClast

Cycle 1, Week 1: AUCtau

Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Benefit of the Treatment With Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib	NCT02056080	Breast Neoplasm		18 Years -	MedSIR
Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)	NCT00239980	Ovarian Cancer	dalteparin	18 Years - 75 Years	Ontario Clinical Oncology Group (OCOG)
ADC-1013 First-in-Human Study	NCT02379741	Neoplasms Solid Tumors	ADC-1013	18 Years -	Alligator Bioscience AB
A Study of PNT2258 in Patients With Advanced Solid Tumors	NCT01191775	Cancer Lymphoma Prostate Cancer Melanoma	PNT2258	18 Years -	Sierra Oncology LLC - a GSK company
CS-7017 in Combination With Erlotinib in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC)	NCT01199068	Carcinoma, Non-...	CS-7017 Erlotinib	18 Years -	Daiichi Sankyo
Study of the Concentration-effect Relationship of Nivolumab in Patients With Kidney or Lung Cancer	NCT03433534	Kidney Cancer Lung Cancer	Pharmacokinetic...	18 Years -	University Hospital, Tours
Clinical Benefit of the Treatment With Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib	NCT02056080	Breast Neoplasm		18 Years -	MedSIR
Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)	NCT00239980	Ovarian Cancer	dalteparin	18 Years - 75 Years	Ontario Clinical Oncology Group (OCOG)
Open Label Clinical Trial of Intravenous Crotoxin Part 3	NCT01481532	Cancer	Crotoxin	18 Years - 75 Years	Celtic Biotech Ltd
Clinical Benefit of the Treatment With Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib	NCT02056080	Breast Neoplasm		18 Years -	MedSIR
A Study of PNT2258 in Patients With Advanced Solid Tumors	NCT01191775	Cancer Lymphoma Prostate Cancer Melanoma	PNT2258	18 Years -	Sierra Oncology LLC - a GSK company

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