Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Skin and Connective Tissue Diseases

Musculoskeletal Diseases

Prostatic Neoplasms

Breast Neoplasms

Bone Resorption

Bone Diseases

Bone Neoplasms

Breast Diseases

Skin Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Bone Density Conservation Agents

All Drugs and Chemicals

Antineoplastic Agents

Zoledronic Acid

Saracatinib

Enzyme Inhibitors

Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period

AZD0530

Richard Finkelman, DDS, PhD

Meabe Aklilu, MD

The purpose of this study is to determine the effect of AZD0530 on subjects with breast cancer or prostate cancer with metastatic bone disease in comparison to zoledronic acid.

Study to Evaluate the Safety and Effects AZD0530 on Prostate and Breast Cancer Subjects With Metastatic Bone Disease

A Phase II, Randomised, Open-Label, Pilot Study to Evaluate the Safety and Effects on Bone Resorption of AZD0530 in Patients With Prostate Cancer or Breast Cancer With Metastatic Bone Disease.

Result at Week 4 minus result at baseline as a percentage of the result at baseline, based on log transformed data. Back transformation of the least squares (LS) mean.

Previous studies have shown that saracatinib reduces osteoclast function and bone resorption. Bone turnover, the combined result of bone formation and bone resorption, can be assessed in real time by measuring specific markers of bone turnover in serum and in urine. These markers were assessed in a study of patients with metastatic bone disease treated with saracatinib. Specific assays are available to quantitate these markers in serum and urine. In this study the effects of saracatinib on bone turnover were compared with the effects of zoledronic acid, a marketed drug known to inhibit bone resorption in cancer patients with bone metastatses.

AstraZeneca

safety set: AZD0530 175mg=68, Zoledronic acid 4mg=69

AZD0530 175 mg

Zoledronic Acid 4 mg

Total

Age Continuous

Sex: Female, Male

Non-compliant patients were excluded from the biomarker analysis, in order to accurately assess effects due to treatment. The compliance criteria did not apply to the zoledronic acid arm, which led to an imbalance in the number of subjects analysed.

Gerard Lynch

The number of participants analyzed reflected the number of paired serum samples per participant that yielded valid assay results, not the total number of participants or completers. The number of evaluable paired serum samples will therefore be a subset of the total number of participants.

Percentage Change From Baseline in Serum Beta C-terminal Cross-linking Telopeptide of Type I Collagen (betaCTX) at Week 4

Percentage Change From Baseline in Serum Bone-specific Alkaline Phosphatase (bALP) at Week 4

Percentage Change From Baseline in Serum Cross-linked C-terminal Telopeptide of Type I Collagen (ICTP) at Week 4

Percentage Change From Baseline in Serum N-terminal Propeptide of Type I Procollagen (PINP) at Week 4

Percentage Change From Baseline in Serum Tartrate-resistant Acid Phosphatase 5b (TRAP5b) at Week 4

Percentage Change From Baseline in Urine N-terminal Cross-linking Telopeptide of Type I Collagen Normalised to Creatinine (NTx/Cr) at Week 4

Percentage Change From Baseline in Urine Alpha-alpha C-terminal Cross-linking Telopeptide of Type I Collagen Normalised to Creatinine (aaCTx/Cr) at Week 4

Saracatinib: Area Under the Curve at Steady State (AUCss)

Saracatinib: Plasma Clearance at Steady State (CLss/F)

Saracatinib: Maximum Plasma Concentration at Steady State (Css,Max)

Saracatinib: Minimum Plasma Concentration at Steady State (Css,Min)

Saracatinib: Time to Cssmax (Tmax)

N-desmethyl Metabolite of Saracatinib: Area Under the Curve at Steady State (AUCss)

N-desmethyl Metabolite of Saracatinib: Maximum Plasma Concentration at Steady State (Css,Max)

N-desmethyl Metabolite of Saracatinib: Minimum Plasma Concentration at Steady State (Css,Min)

N-desmethyl Metabolite of Saracatinib: AUCss Metabolite to Parent Ratio

N-desmethyl Metabolite of Saracatinib: Time to Cssmax (Tmax)

Overall Study

Digestive System Diseases

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Cholangiocarcinoma

Pancreatic Neoplasms

Stomach Neoplasms

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Multiple Myeloma

Neoplasms, Plasma Cell

Liver Neoplasms

Choriocarcinoma

Pancreatic Cancer

Ovarian Cancer

Bile Duct Cancer

Stomach Cancer

Ovarian Epithelial Cancer

Hematinics

Herbal and Botanical

Liver Extracts

Cediranib

Protein Kinase Inhibitors

Cola

oral tablet multiple ascending doses 20, 30 or 45 mg

AZD2171

oral tablet multiple ascending doses 125 mg or 175 mg

Jane Roberston

Tanja Trarbach, MD

The purpose of the study is to determine if the maximum tolerated doses of AZD2171, in combination with AZD0530, in treating patients with advanced solid tumours are safe, tolerable and efficacious.

Safety and Tolerability Study of AZD2171 in Combination With AZD0530 in Patients With Advanced Solid Tumours

Phase I, Open-Label Study To Assess the Safety, Tolerability and Pharmacokinetics of Daily Oral Doses of Cediranib (RECENTIN™;AZD2171) (20, 30 or 45mg) When Co-Administered With Daily Oral Doses of AZD0530 (125mg or 175mg) in Patients With Advanced Solid Tumours

Jane Robertson, MSD

Carcinoma, Non-Small-Cell Lung

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

AZD0530 in combination with carboplatin and paclitaxel

paclitaxel

Mary Stuart

Takashi Seto, MD, PhD

Naoyuki Nogami, MD

The primary purpose of this study is to explore the safety and tolerability of AZD0530 in combination with carboplatin and paclitaxel in Japanese patients with non small cell lung cancer and epithelial ovarian cancer.

Study to Assess Safety and Tolerability of AZD0530 in Combination With Carboplatin and Paclitaxel

A Phase I, Open-Label, Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ascending Doses of AZD0530 in Combination With Carboplatin and Paclitaxel Chemotherapy in Japanese Patients With Advanced Solid Malignancies

Symptoms and General Pathology

Recurrence

Osteosarcoma

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Sarcoma

Oculocerebral Syndrome With Hypopigmentation

Soft Tissue Sarcoma

Saracatinib will be administered as a once daily, oral dose of 175 mg, for a 28-day cycle, with no breaks between cycles. The duration of treatment with saracatinib will be 13 cycles.

Placebo will be administered as a once daily, oral dose of 175 mg, for a 28-day cycle, with no breaks between cycles. The duration of treatment with placebo will be 13 cycles.

Placebo

Kristin Baird, MD

The purpose of this study is to determine how long patients who undergo complete surgical removal of recurrent osteosarcoma in the lung will remain free of cancer after taking Saracatinib compared to patients taking placebo (a sugar pill).

Further details provided by SARC (Sarcoma Alliance for Research through Collaboration):

After complete surgical removal of their cancer, patients will be randomly assigned to receive either Saracatinib or placebo (a sugar pill) throughout the study. Patients will take Saracatinib (or placebo) once daily by mouth for a total of 364 days. The duration of treatment is divided into 13 cycles, 28 days each cycle with no breaks in between.

Patients will be seen for interim medical history, physical exam and laboratory studies prior to each cycle. To monitor for recurrence of tumor, patients will undergo thoracic CT scans at 3-4 weeks, 6-8 weeks, at 3 months, at 6 months, at 9 months, at 12 months, then every 6 months up to 2 years, and then every year up to 5 years after starting treatment. An electrocardiogram (ECG) will be taken at 3 months, and a bone scan will be performed at 12 months.

Patients who recur in the lung while on-study and who are thought to be amenable to complete surgical resection will be able to find out if they were receiving placebo or saracatinib. Those patients who were receiving placebo may then have the option of undergoing surgical resection. If fully resected of all recurrent disease,they will be given the option of receiving oral therapy with saracatinib. Saracatinib will be administered as a once daily, oral dose of 175 mg, for a 28-day cycle, with no breaks between cycles. The duration of treatment with saracatinib will be thirteen 28-day cycles (364 days total). If complete resection of all lung nodules is not achieved, the patient will be removed from the study.

Patients who recur in locations other than the lung while on-study will be taken off study at that time.

Blood and tumor samples for research purposes will be collected at the time the tumor is removed.

After completing all 13 cycles, patients will be followed for approximately every 3 months until 2 years from starting treatment, then approximately every 6 months until 4 years from starting treatment, and once at year 5.

A Placebo-Controlled Study of Saracatinib (AZD0530) in Patients With Recurrent Osteosarcoma Localized to the Lung

A Randomized, Double-Blinded, Placebo-Controlled, Multi-Institutional, Cross-over, Phase II.5 Study of Saracatinib (AZD0530), a Selective Src Kinase Inhibitor, In Patients With Recurrent Osteosarcoma Localized to the Lung

To determine if the addition of saracatinib to pulmonary metastasectomy, versus placebo and pulmonary metastasectomy, results in a change in progression free survival.

To determine if the addition of saracatinib to pulmonary metastasectomy, versus placebo and pulmonary metastasectomy, results in a change in overall survival.

To determine if the addition of saracatinib to pulmonary metastasectomy, versus placebo and pulmonary metastasectomy, results in a change in the time to treatment failure. Time to treatment failure is the time from randomization to treatment discontinuation.

To perform microarray analysis of tumor samples to identify a gene signature that predicts for recurrence of osteosarcoma using methodology that relies on preparation of RNA, followed by cDNA. Fluorescent labeling followed by hybridization to a DNA chip allows for quantitative scanning for hybridized complexes.

To evaluate tumor samples for biomarkers related to activation of Src and Src substrates.

To establish cell lines and murine xenografts from recurrent tumor samples.

To perform sequencing analysis of DNA and RNA in tumor samples compared to normal blood to detect mutations that may be causative for recurrent osteosarcoma. The methodology uses transcriptome sequencing, exon re-sequencing and mate-pair end sequencing, allowing us to detect translocations. The availability of matched normal DNA in the blood will allow us to determine which changes are unique to the tumor.

Sarcoma Alliance for Research through Collaboration

Saracatinib: Oral Agent

Administered once daily, oral dose of 175 mg for a 28 day cycle.

Administered once daily, oral dose of 175 mg for a 28 day cycle.

Placebo

Administered once daily, oral dose of 175 mg for a 28 day cycle.

Age, Customized

Ethnicity (NIH/OMB)

Race (NIH/OMB)

38 subjects were randomized to receive therapy. One subject was taken off study for pregnancy, therefore 37 subjects were included in the analysis.

Histology types

SARC

38 subjects were randomized to receive therapy. One randomized subject was subsequently taken off-study for pregnancy; therefore 37 subjects were included in the analysis.

Progression Free Survival Rate Among Patients Treated With Saracatinib and Placebo.

Change in Overall Survival With the Addition of Saracatinib to Pulmonary Metastasectomy, Versus Placebo and Pulmonary Metastasectomy

Did not perform time to progression analysis, but rather evaluated PFS. There was no data to report for time to treatment failure.

Change in Time to Treatment Failure With the Addition of Saracatinib to Pulmonary Metastasectomy, Versus Placebo and Pulmonary Metastasectomy

Number of Genes Identified for Prediction of Recurrence of Osteosarcoma

Biomarkers Related to Activation of Src and Src Substrates

Cell Lines and Murine Xenografts From Recurrent Tumor Samples

Number of Mutations Identified That May be Causative For Recurrent Osteosarcoma

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Gastrointestinal Agents

Gemcitabine

Pancrelipase

Pancreatin

Antimetabolites

gemcitabine hydrochloride

Malcolm J. Moore, MD

Sharlene Gill, MD

RATIONALE: AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving AZD0530 together with gemcitabine may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of AZD0530 when given together with gemcitabine and to see how well they work in treating patients with locally advanced or metastatic pancreatic cancer that cannot be removed by surgery.

OBJECTIVES:

Phase I

* Determine the maximum tolerated dose of AZD0530 when given in combination with gemcitabine in patients with unresectable, locally advanced or metastatic pancreatic cancer.
* Determine the safety and tolerability of this regimen in these patients.
* Determine toxicity profile and dose-limiting toxicity of this regimen in these patients.
* Determine pharmacokinetic profile of this regimen in these patients.
* Correlate the toxicity profile with the pharmacokinetics of this regimen in these patients.

Phase II

* Determine the objective response rate (partial and complete response) and prolonged stable disease rate in patients treated with this regimen.
* Determine the median survival, 1-year survival, response or stable disease duration, time to disease progression, clinical benefit response, and progression-free survival of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
* Correlate changes in serum CTX levels (post-treatment vs baseline) with response and other clinical outcomes in patients treated with this regimen.

OUTLINE: This is a phase I, open-label, multicenter, dose-escalation study of AZD0530 followed by a phase II study.

* Phase I: Patients receive oral AZD0530 once daily on days 1-28 and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients receive 2 additional courses after achieving complete response or stable partial response. Patients with ongoing stable disease receive up to 6 courses. Patients who discontinue gemcitabine due to unacceptable toxicity or who complete 6 courses of therapy may continue to receive AZD0530 alone in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of AZD0530 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.

* Phase II: Patients receive AZD0530 at the MTD determined in phase I and gemcitabine as in phase I.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

AZD0530 and Gemcitabine in Locally Advanced/Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery

A Phase I/II Study of AZD0530 in Combination With Gemcitabine in Patients With Advanced Pancreatic Cancer

Response is assessed every other cycle and will be reported on at final analysis

Toxicity is assessed from the time of first treatment and final results will be reported at final analysis

NCIC Clinical Trials Group

oral, tablet, once daily, dose will be variable

Mary Stuart, MD

Narikazu Boku, MD

This is a dose escalation study to assess the safety and tolerability of AZD0530 in patients with advanced solid malignancies.

AZD0530 Study 21 - Phase I Study in Patients With Solid Tumours

A Phase I, Open-label, Dose-escalation Study to Assess the Safety and Tolerability of AZD0530 in Patients With Advanced Solid Malignancies

Dr Mary Stuart, BSc MSc MB BCh BAO MRCPI, Medical Science Director Emerging Oncology Product Team 1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study to Evaluate the Safety and Effects AZD0530 on Prostate and Breast Cancer Subjects With Metastatic Bone Disease	NCT00558272	Breast Cancer Prostate Cancer Bone Neoplasms	AZD0530 Zoledronic Acid	18 Years -	AstraZeneca
Safety and Tolerability Study of AZD2171 in Combination With AZD0530 in Patients With Advanced Solid Tumours	NCT00475956	Neoplasms	AZD2171 AZD0530	18 Years -	AstraZeneca
Study to Assess Safety and Tolerability of AZD0530 in Combination With Carboplatin and Paclitaxel	NCT01000896	Cancer Non Small Cell ... Epithelial Ovar...	AZD0530 Carboplatin paclitaxel	20 Years -	AstraZeneca
A Placebo-Controlled Study of Saracatinib (AZD0530) in Patients With Recurrent Osteosarcoma Localized to the Lung	NCT00752206	Osteosarcoma	Saracatinib Placebo	15 Years - 74 Years	Sarcoma Alliance for Research through Collaboration
A Placebo-Controlled Study of Saracatinib (AZD0530) in Patients With Recurrent Osteosarcoma Localized to the Lung	NCT00752206	Osteosarcoma	Saracatinib Placebo	15 Years - 74 Years	Sarcoma Alliance for Research through Collaboration
Study to Evaluate the Safety and Effects AZD0530 on Prostate and Breast Cancer Subjects With Metastatic Bone Disease	NCT00558272	Breast Cancer Prostate Cancer Bone Neoplasms	AZD0530 Zoledronic Acid	18 Years -	AstraZeneca
Study to Evaluate the Safety and Effects AZD0530 on Prostate and Breast Cancer Subjects With Metastatic Bone Disease	NCT00558272	Breast Cancer Prostate Cancer Bone Neoplasms	AZD0530 Zoledronic Acid	18 Years -	AstraZeneca
AZD0530 and Gemcitabine in Locally Advanced/Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery	NCT00265876	Pancreatic Canc...	AZD0530 gemcitabine hyd...	18 Years - 120 Years	Canadian Cancer Trials Group
AZD0530 Study 21 - Phase I Study in Patients With Solid Tumours	NCT00704366	Solid Tumor	AZD0530	20 Years -	AstraZeneca
Study to Evaluate the Safety and Effects AZD0530 on Prostate and Breast Cancer Subjects With Metastatic Bone Disease	NCT00558272	Breast Cancer Prostate Cancer Bone Neoplasms	AZD0530 Zoledronic Acid	18 Years -	AstraZeneca
Study to Assess Safety and Tolerability of AZD0530 in Combination With Carboplatin and Paclitaxel	NCT01000896	Cancer Non Small Cell ... Epithelial Ovar...	AZD0530 Carboplatin paclitaxel	20 Years -	AstraZeneca

Spots Global Cancer Trial Database for azd0530

Every month we try and update this database with for azd0530 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for azd0530

Every month we try and update this database with for azd0530 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for azd0530 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.