Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Antimetabolites

Gemcitabine and demcizumab With or Without Abraxane®

Up to 50 subjects will be enrolled at up to 8 centers in Australia, New Zealand, and Spain. Up to 28 days (4 weeks) prior to treatment you will undergo testing to determine your eligibility to take part in this study, and then if you are enrolled in the study you will receive intravenous (in the vein) infusions of the demcizumab administered once every 2 weeks, and gemcitabine and Abraxane® administered weekly for 3 weeks, out of every 4 weeks. After 9 weeks, you will undergo assessments to determine the status of your disease. If there is no evidence of progression of your disease or if your tumor is smaller, you will continue to receive one additional infusion of demcizumab, and you will continue to receive infusions of gemcitabine and Abraxane® once weekly for 3 consecutive weeks out of every 4 weeks until it has been shown that your cancer has progressed. You will undergo assessments every 8 weeks thereafter to determine the status of your disease.

Demcizumab

Abraxane® which will be administered by IV infusion at a dose of 125 mg/m2 over 30 minutes once a week for 3 weeks in a row, followed by a week of rest.

Abraxane®

Gemcitabine will be administered intravenously over 30 minutes initially at a dose of 1000 mg/m2 once a week for 3 weeks in a row, followed by a week of rest. If you develop side effects during this time period, your physician may decide to hold or reduce the dose of gemcitabine.

The purpose of this study is to test the safety and determine the optimal dose of a new experimental drug, demcizumab (OMP-21M18), when given in combination with gemcitabine with or without (+/-) Abraxane®. Historically, single agent gemcitabine has been the standard treatment for pancreatic cancer. However, recent data suggests that gemcitabine plus Abraxane® may be superior to gemcitabine alone, thus this combination is emerging as the new standard therapy for pancreatic cancer. However, Abraxane® has not been approved for the treatment of pancreatic cancer at this time. Demcizumab is a humanized monoclonal antibody and was developed to target cancer stem cells. This study is sponsored by OncoMed Pharmaceuticals, which is referred to as OncoMed or the Sponsor in this consent form. The study is designed to test the safety of demcizumab at different dose levels when given with gemcitabine +/- Abraxane® and the effects, both good and bad, that it has on participants. Demcizumab may block the growth of cancer stem cells, the remaining tumor cells, and it may also prevent the growth of new blood vessels that tumors need to grow and spread. Although demcizumab has been administered with gemcitabine to cancer patients, it has not been given in combination with gemcitabine and Abraxane®; thus, it is not known if it will provide any benefit to participants and may cause harmful side effects.

Current cancer therapies often produce an initial reduction in tumour size but may not have long term benefits. One possible explanation for this is the presence cancer cell known as a cancer stem cells. Cancer stem cells represent a small part of the tumour but are believed to be responsible for much of the growth and spread of the cancer. They may also be more resistant to traditional therapy, such as chemotherapy and radiation therapy.

The purpose of this study is to test the safety and determine the optimal dose of a new experimental drug, demcizumab, when given in combination with gemcitabine, a drug that is a standard treatment for advanced pancreatic cancer that has not been treated previously with chemotherapy. Demcizumab is a humanized monoclonal antibody (a protein made in the laboratory) and was developed to target cancer stem cells. The way the body handles demcizumab will also be investigated.

Up to 50 subjects will be enrolled at up to 8 centers in Australia, New Zealand, and Spain. Up to 28 days (4 weeks) prior to treatment you will undergo testing to determine your eligibility to take part in this study, and then if you are enrolled in the study you will receive intravenous (in the vein) infusions of the demcizumab administered once every 2 weeks, and gemcitabine and Abraxane® administered weekly for 3 weeks, out of every 4 weeks. After 9 weeks, you will undergo assessments to determine the status of your disease. If there is no evidence of progression of your disease or if your tumor is smaller, you will continue to receive one additional infusion of demcizumab, and you will continue to receive infusions of gemcitabine and Abraxane® once weekly for 3 consecutive weeks out of every 4 weeks until it has been shown that your cancer has progressed. You will undergo assessments every 8 weeks thereafter to determine the status of your disease. If there is no evidence of progression of your disease or if your tumor is smaller, you will continue to receive one additional infusion of demcizumab, and you will continue to receive infusions of gemcitabine and Abraxane® once weekly for 3 consecutive weeks out of every 4 weeks until it has been shown that your cancer has progressed. You will undergo assessments every 8 weeks thereafter to determine the status of your disease.

In addition to routine testing of blood and urine (for complete blood counts with differential and platelets, coagulation studies to determine how quickly your blood is clotting , serum chemistries, B-type natriuretic peptide \[BNP\] and Troponin I which indicates how well your heart if working, and urinalysis), special tests will be performed during the study at specific time points.

In addition, you will have and ECG and Doppler echocardiogram performed during screening, then every 28 days on study and at treatment termination. Your Doppler echocardiograms may be sent to a Cardiologist at another hospital who may perform a central read on some of the Doppler echocardiograms in this study. Finally, you will have a head CT or MRI at baseline and CT scans and/or other radiographs performed every 56 days to assess the status of your tumor.

The study includes an optional part which will investigate how variations in people's genetic makeup affect their response to medications. This involves the collection of one blood sample just before participants receive their first dose of study treatment. DNA will be extracted from the blood sample for testing.

A Study of Gemcitabine and Demcizumab (OMP-21M18) With or Without Abraxane® as 1st-line Treatment in Subjects With Locally Advanced or Metastatic Pancreatic Cancer

A Phase 1b Study of Gemcitabine and Demcizumab (OMP-21M18) With or Without Abraxane® as 1st-line Treatment in Subjects With Locally Advanced or Metastatic Pancreatic Cancer

Novotech (Australia) Pty Limited

OncoMed Pharmaceuticals, Inc.

0.5, 1, 2.5, 5, and 10 mg/kg weekly until day 56. If patient has not progressed may continue with original dose administered every other week until progression

OMP-21M18

A phase 1 open-label dose escalation study of OMP-21M18 in subjects with previously treated solid tumour for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit.

This is an open-label Phase 1 dose escalation study of OMP-21M18 in subjects with previously treated solid tumors for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit. Up to 30 subjects will be enrolled at up to 4 centers. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and efficacy. No formal interim analyses will be performed. Prior to enrollment, subjects will undergo screening to determine study eligibility. Upon enrollment, subjects will receive weekly intravenous (IV) infusions of OMP-21M18 for 9 weeks. After 9 weeks of treatment, subjects will be assessed for disease status. If there is no evidence of disease progression or if the tumor is smaller, then subjects may continue to receive IV infusions of OMP-21M18 every other week until disease progression.

Dose escalation will be conducted to determine the maximum tolerated dose (MTD). The dose levels of OMP 21M18 will be 0.5, 1.0, 2.5, 5, and 10 mg/kg administered IV weekly for 9 doses. No dose escalation or reduction will be allowed within a dose cohort. The dose may be administered at any time during the day. Three subjects will be treated at each dose level if no dose-limiting toxicities (DLTs) are observed. If 1 of 3 subjects experience a DLT, that dose level will be expanded to 6 subjects. If 2 or more subjects experience a DLT, no further subjects will be dosed at that level and 3 additional subjects will be added to the preceding dose cohort unless 6 subjects have already been treated at that dose level. Subjects will be assessed for DLTs from the time of the first dose through 7 days after administration of the 4th dose, but prior to administration of the 5th dose (i.e., Days 0-28). Dose escalation, if appropriate, will occur after all subjects in a cohort have completed their Day 28 DLT assessment.

A Phase 1 Dose Escalation Study of OMP-21M18 in Subjects With Solid Tumors

Micronutrients

Hematinics

Vitamins

Pemetrexed

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

gemcitabine administered in combination with AZD6918

pemetrexed administered in combination with AZD6918

AZD6918

intravenous, doses are on an intermittent schedule

gemcitabine

intravenous, dose administered every 21-days

pemetrexed

Judith Ochs, MD

Jeffrey Infante, MD

Lia Gore, MD

The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD6918 based on the side effects experienced by patients with advanced solid malignancies that receive daily AZD6918 alone. It is possible that AZD6918 will be administered twice daily. Then maximum tolerated doses in combination with either gemcitabine or pemetrexed will also be investigated.

Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD6918

A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6918 Administered Daily as a Single Agent and in Combination Treatment in Adult Patients With Refractory Solid Malignancies

AstraZeneca

Judith Ochs, M.D. Medical Science Director

Symptoms and General Pathology

Neoplasm Metastasis

Carboplatin

Vadimezan

ASA404

Novartis Pharmaceuticals

This study is designed to obtain pharmacokinetic data following a single-dose 20-minute i.v. administration of ASA404 (900, 1200, or 1800 mg/m2) in adult cancer patients with varying degrees of hepatic impairment. The study will be carried out in cancer volunteer patients (utilizing controls with normal hepatic function) who will be assigned to four hepatic impairment groups according to their pre-dose (Day-1) and total bilirubin level. The study will consist of two phases, a (Core Phase) that will evaluate the pharmacokinetics of a single i.v. dose (900, 1200 and 1800 mg/m2) of ASA404 in adult cancer patients with impaired hepatic function, and compared to controls with normal hepatic function. The assessments will be done on the safety and tolerability of that single dose in adult cancer patients with impaired hepatic function and compared to controls with normal hepatic function. The Extension Phase will consist of assessing the safety and tolerability of ASA404 at the same three doses in combination with a sponsor-approved taxane-based regimen in adult cancer patients with impaired hepatic function and compared to controls with normal hepatic function.

An Open-label, Dose Escalation Study to Assess the Pharmacokinetics of of ASA404 in Adult Cancer Patients With Impaired Hepatic Function

A Multi-center, Open-label, Dose-escalation Study to Assess the Pharmacokinetics of ASA404 in Adult Cancer Patients With Impaired Hepatic Function and With Normal Hepatic Function

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Renal Insufficiency

Neoplastic Processes

Kidney Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

ASA404, DMXAA or DXAA

The purpose of this study is to evaluate the safety and pharmacokinetics of ASA404 in patients with refractory or relapsed metastatic cancer with impaired renal function and with normal renal function. It is very possible that patients with renal impairment will show differences in renal excretion of parent ASA404 and its metabolites, warranting a study that leads to a better pharmacokinetic assesssment in this population.

A Dose-escalation Pharmacokinetic Study of Intravenous ASA404 in Adult Advanced Cancer Patients With Impaired Renal Function and Patients With Normal Renal Function

A Multi-center, Open-label, Dose-escalation Study to Assess the Pharmacokinetics of Intravenous ASA404 in Adult Advanced Cancer Patients With Impaired Renal Function and With Normal Renal Function

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Urologic Neoplasms

Urogenital Neoplasms

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Sorafenib

Protein Kinase Inhibitors

Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.

The initial dose of sorafenib will be 400 mg bid administered orally, on a continuous basis. A treatment cycle is considered to be 28 days. Intrapatient dose escalation will occur according to the following schedule, providing no grade 3 or 4 toxicities are observed (except for alopecia, nausea and vomiting); Day 1-28 400 mg bid, Day 29-56 600 mg bid, Day 57 onwards 800 mg bid. Subjects will continue on treatment until progression, unacceptable toxicity, subject withdraws consent or the decision is taken to stop the study following the analysis of response rates.

Sorafenib (Nexavar, BAY43-9006)

Bayer Study Director

Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of advanced kidney cancer. It is also currently being tested in various other cancers. Sorafenib works by stopping the development of new cancer cells and new blood vessels. By stopping the growth of new blood vessels around a tumor, it is believed that sorafenib prevents the growth of kidney cancer tumors.

This is an "open-label" study which means that the patient, the doctor and Bayer Healthcare will know what tablets the patient is taking. All patients in this study will receive sorafenib tablets. Sorafenib is taken orally as a tablet (two tablets are taken twice a day). Treatment with sorafenib will continue until the patient's tumor grows larger or spreads further or if the patient has intolerable side effects. The dose of sorafenib that the patient will receive in the study will increase at certain points during the patient's treatment, as long as the patient is not experiencing side effects and the patient's tumor has not grown.

Issues on Outcome Measure "Safety and tolerability" will be addressed in the Adverse Events section.

Sorafenib Dose Escalation in Renal Cell Carcinoma

A Phase II, Multi-centre, Open-label Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of Intrapatient Dose Escalation of Sorafenib as First Line Treatment for Metastatic Renal Cell Carcinoma.

Tumor Response of a subject was defined as the best tumor response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed Complete Response (CR) was defined as disappearance of tumor, Partial Response (PR) was defined as a decrease of at least 30% in the sum of target lesions, Stable Disease (SD) was defined as steady state of disease, and Progressive Disease (PD) was defined as at least a 20% increase in the sum of measured lesions or appearance of new lesions.

Disease Control (DC) of a subject was defined as the proportion of patients with confirmed Complete Response (CR), Partial Response (PR) or Stable Disease (SD) as their best response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed CR was defined as disappearance of tumor, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, and SD was defined as steady state of disease.

Best Response (Response Rate) of a subject was defined as the proportion of patients with confirmed Complete Response (CR) or Partial Response (PR) as their best response observed (by independent central assessment) during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) criteria. Confirmed CR was defined as disappearance of tumor and PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes.

AUC(0-10),ss was defined as an area under the plasma concentration versus time curve from time zero to 10 hours post-dose. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib.

AUC(0-12),ss was defined as an area under the plasma concentration versus time curve from time zero to 12 hours post-dose. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib.

Cmax was defined as a maximum plasma concentration at steady-state. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib.

Tmax was defined as a time to maximum concentration at steady-state. Parameter was calculated for sorafenib and M2, an active metabolite of sorafenib.

Progression-free survival (PFS) was defined as the time from start of study medication to the first documented disease progression per RECIST (by independent radiological assessment) or clinical progression as per investigator assessment or death due to any cause whichever occurred first. For patients who had not recurred or died at the time of analysis, PFS was censored at their last date of evaluable scan.

Time to progression (TTP) was defined as the time from start of study medication to the first documented disease progression per RECIST (by independent radiological assessment) or clinical progression as per investigator assessment whichever occurred first. For patients who had not progressed at the time of analysis or died before progression, TTP was censored at their last date of evaluable scan.

Bayer

Abbreviations used in the Adverse Events section: Gastrointestinal (GI), Not Otherwise Specified (NOS), Absolute Neutrophil Count (ANC), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Gamma glutamyl transpeptidase (GGT)

Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle,600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.

Age, Continuous

Sex: Female, Male

Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects the daily life of a patient on an ordinal scale from grade 0 (best) to grade 5 (worst). Status 0 = fully active; Status 1 = restricted strenuous activity, ambulatory and able to carry out work of a light or sedentary nature

ECOG (Eastern Cooperative Oncology Group) Performance Status

Stage III

Stage IV

Categorized information on tumor size, lymph node involvement and metastases. Stages I-IV. The higher the stage, the more advanced cancer.

Stage at study entry

Therapeutic Area Head

The population for the analysis of primary efficacy variable was the modified intent-to-treat (mITT) population defined as the patients treated for at least 6 months with 4 months at their highest tolerated dose.

Best Response - mITT (Modified Intent-to-treat) Population

Complete Response (CR)

Partial Response (PR)

Stable Disease (SD)

Progressive Disease (PD)

The population for the efficacy analysis was the intent-to-treat (ITT) population defined as all patients who received at least one dose of study medication with at least one valid tumor assessment post-baseline.

Tumor Response - ITT (Intent to Treat) Population

Sorafenib (N=40, 30, 26)

M2 (BAY67-3472) (N=40, 30, 27)

Participants received 400 mg orally twice daily (bid)

Sorafenib (Nexavar, BAY43-9006)_400 mg

Participants received 600 mg orally twice daily (bid)

Sorafenib (Nexavar, BAY43-9006)_600 mg

Participants received 800 mg orally twice daily (bid)

Sorafenib (Nexavar, BAY43-9006)_800 mg

PK Analysis Population. 40 participants in the 400 mg bid group that had an AUC(0-10)ss calculated; 30 participants in the 600 mg bid group that had an AUC(0-10)ss calculated; 26 participants and 27 participants in the 800 mg bid group that had an AUC(0-10)ss calculated, for sorafenib and M2 parameter respectively.

Pharmacokinetics (PK) Analysis - Area Under the Drug Concentration-time Curve From Time Zero to 10 Hours Postdose (AUC(0-10),ss)

Sorafenib (N=32, 23, 19)

M2 (BAY67-3472) (N=32, 23, 20)

PK Analysis Population. 32 participants in the 400 mg bid group that had an AUC(0-12)ss calculated; 23 participants in the 600 mg bid group that had an AUC(0-12)ss calculated; 19 participants and 20 participants in the 800 mg bid group that had an AUC(0-12)ss calculated, for sorafenib and M2 parameter respectively.

Pharmacokinetics (PK) Analysis - Area Under the Drug Concentration-time Curve From Time Zero to 12 Hours Postdose (AUC(0-12),ss)

M2 (BAY67-3472)

PK Analysis Population. 40 participants in the 400 mg bid group that had Cmax calculated; 31 participants in the 600 mg bid group that had Cmax calculated; 28 participants in the 800 mg bid group that had Cmax calculated.

Pharmacokinetics (PK) Analysis - Maximum Observed Concentration in Plasma (Cmax)

PK Analysis Population. 40 participants in the 400 mg bid group that had Tmax calculated; 31 participants in the 600 mg bid group that had Tmax calculated; 28 participants in the 800 mg bid group that had Tmax calculated.

Pharmacokinetics (PK) Analysis - Time to Maximum Concentration (Tmax)

Progression-free Survival (PFS)

Time to Progression (TTP)

Complete response (CR)

Partial response (PR)

Stable disease (SD)

Progressive disease (PD)

Tumor Response - mITT Population

Disease Control - mITT Population

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Carboplatin and Pemetrexed plus demcizumab

The 6 subjects in the first cohort will receive demcizumab 5 mg/kg once every 3 weeks; the 6 subjects in the subsequent cohort will be treated with 10 mg/kg once every 3 weeks; and the 6 subjects in the final cohort will be treated with 15 mg/kg once every 3 weeks. A Data Safety Monitoring Board (DSMB) will review the data for the 6 subjects in each dose cohort after the last subject in that cohort has been on study for 56 days and then decide whether it is safe to escalate to the next highest dose cohort. Once the dose-escalation portion of the study has been completed, 14 additional subjects will be treated at the highest dose level that the DSMB deems as safe.

The purpose of this study is to test the safety and determine the optimal dose of a new drug, demcizumab (OMP-21M18), when given in combination with carboplatin and pemetrexed, a standard drug treatment regimen for non-squamous non-small cell lung cancer (NSCLC). Participants must not have received prior chemotherapy for their NSCLC. Demcizumab is a humanized monoclonal antibody (a protein made in the laboratory) developed to target cancer stem cells. The way the body handles demcizumab will also be investigated.

Up to 50 subjects will be enrolled at up to 8 centers in Australia, New Zealand, and Spain. Up to 28 days (4 weeks) prior to treatment you will undergo testing to determine your eligibility to take part in this study, and then if enrolled in the study you will receive intravenous (in the vein) infusions of the demcizumab, carboplatin, and pemetrexed administered on the same day, every 21 days for 4 cycles, or until it has been shown that your cancer has progressed. If your physician decides to delay treatment with one of the agents due to side effects, the other agents may still be administered as scheduled. After 4 cycles, if you have stable or improved disease, you will continue to receive pemetrexed once every 21 days as maintenance therapy. You will undergo assessments every 8 weeks to determine the status of your disease.

Current cancer therapies often produce an initial reduction in tumour size but may not have longterm benefits. One possible explanation for this is the presence of cancer cells known as cancer stem cells. Cancer stem cells represent a small part of the tumour but are believed to be responsible for much of the growth and spread of the cancer. They may also be more resistant to traditional therapy, such as chemotherapy and radiation therapy.

Up to 50 subjects will be enrolled at up to 8 centers in Australia, New Zealand, and Spain. Up to 28 days (4 weeks) prior to treatment you will undergo testing to determine your eligibility to take part in this study, and then if enrolled in the study you will receive intravenous (in the vein) infusions of the demcizumab, carboplatin, and pemetrexed administered on the same day, every 21 days for 4 cycles, or until it has been shown that your cancer has progressed. If your physician decides to delay treatment with one of the agents due to side effects, the other agents may still be administered as scheduled. After 4 cycles, if you have stable or improved disease, you will continue to receive pemetrexed once every 21 days as maintenance therapy. You will undergo assessments every 8 weeks to determine the status of your disease.

In addition to routine testing of blood and urine (for complete blood counts with differential and platelets, coagulation studies to determine how quickly your blood is clotting; serum chemistries; B-type natriuretic peptide \[BNP\] and Troponin I, which indicate how well your heart if working; creatinine clearance to measure your kidney function and urinalysis), special tests will be performed during the study at specific time points.

In addition, you will have an ECG and doppler echocardiogram performed during screening, then every 28 days on study and at treatment termination. Your Doppler echocardiograms may be sent to a Cardiologist at another hospital who may perform a central read on some of the doppler echocardiograms in this study. Finally, you will have a head CT or MRI at baseline and CT scans and/or other radiographs performed every 56 days to assess the status of your tumor.

The study includes an optional part which will investigate how variations in people's genetic makeup affect their response to medications. This involves the collection of one blood sample just before participants receive their first dose of study treatment. DNA will be extracted from the blood sample for testing.

A Study of Carboplatin and Pemetrexed Plus Demcizumab (OMP-21M18) in Subjects With Non-Squamous Non-Small Cell Lung Cancer

A Phase 1b Study of Carboplatin and Pemetrexed Plus Demcizumab (OMP-21M18) as 1st-line Treatment in Subjects With Non-Squamous Non-Small Cell Lung Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Gemcitabine and Demcizumab (OMP-21M18) With or Without Abraxane® as 1st-line Treatment in Subjects With Locally Advanced or Metastatic Pancreatic Cancer	NCT01189929	Pancreatic Canc...	Demcizumab Abraxane® Gemcitabine	21 Years -	Mereo BioPharma
A Phase 1 Dose Escalation Study of OMP-21M18 in Subjects With Solid Tumors	NCT00744562	Solid Tumors	OMP-21M18	21 Years -	Mereo BioPharma
Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD6918	NCT00733031	Cancer, Solid Tumors Advanced Solid ...	AZD6918 gemcitabine pemetrexed	18 Years -	AstraZeneca
An Open-label, Dose Escalation Study to Assess the Pharmacokinetics of of ASA404 in Adult Cancer Patients With Impaired Hepatic Function	NCT01278849	Histologically-...	ASA404	18 Years -	Novartis
A Dose-escalation Pharmacokinetic Study of Intravenous ASA404 in Adult Advanced Cancer Patients With Impaired Renal Function and Patients With Normal Renal Function	NCT01278758	Metastatic Canc...	ASA404, DMXAA o...	18 Years -	Novartis
Sorafenib Dose Escalation in Renal Cell Carcinoma	NCT00618982	Carcinoma, Rena...	Sorafenib (Nexa...	18 Years -	Bayer
An Open-label, Dose Escalation Study to Assess the Pharmacokinetics of of ASA404 in Adult Cancer Patients With Impaired Hepatic Function	NCT01278849	Histologically-...	ASA404	18 Years -	Novartis
A Study of Carboplatin and Pemetrexed Plus Demcizumab (OMP-21M18) in Subjects With Non-Squamous Non-Small Cell Lung Cancer	NCT01189968	Non Small Cell ...	Demcizumab	21 Years -	Mereo BioPharma
A Study of Gemcitabine and Demcizumab (OMP-21M18) With or Without Abraxane® as 1st-line Treatment in Subjects With Locally Advanced or Metastatic Pancreatic Cancer	NCT01189929	Pancreatic Canc...	Demcizumab Abraxane® Gemcitabine	21 Years -	Mereo BioPharma

Spots Global Cancer Trial Database for dose escalation,