Antineoplastic Agents

All Drugs and Chemicals

Epothilone B

Epothilones

Tubulin Modulators

Antimitotic Agents

Patupilone

Novartis Pharmaceuticals

The main purpose of this study is to characterize the distribution, metabolism, and elimination (ADME) of Patupilone after a single intravenous administration in patients with advanced solid tumor malignancies

Pharmacokinetics of Patupilone After a Single Intravenous Administration in Patients With Advance Solid Tumor Malignancies.

An Open-label Single Center Study to Characterize the Absorption, Distribution, Metabolism, and Elimination (ADME) of Patupilone (EPO906) After a Single Intravenous Administration of 10 mg/m2 [14C] Patupilone in Patients With Advanced Solid Tumor Malignancies.

External Affairs

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Nervous System Diseases

Substance Related Disorders

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Disease Progression

Peritoneal Neoplasms

Neurotoxicity Syndromes

Carcinoma

Fallopian Tube Neoplasms

Syndrome

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

Fallopian Tube Diseases

Poisoning

Chemically-Induced Disorders

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Paclitaxel

Albumin-Bound Paclitaxel

Laure COPEL, Physician

validation of a french version of FACT-GOG/NTX and using this questionnaire to evaluate the incidence of the peripheral neurotoxicity in patients treated for ovarian cancer with paclitaxel associated or not with EPO.

Use of FACT-GOG/NTX Questionnaire in Peripheral Neurotoxicity & Validation of a French Version of This Questionnaire

A Multicenter Prospective Phase II Study Evaluating Peripheral Neurotoxicity by Using FACT-GOG/NTX Questionnaire in Patients With Ovarian Cancer in Relapse Treated by Paclitaxel +/- EPO. Validation of a French Version of This Questionnaire

ARCAGY/ GINECO GROUP

Blood and Lymph Conditions

Anemia

Hematologic Diseases

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Hematinics

Chrysarobin

Epoetin Alfa

Peginesatide starting dose of 0.1 milligram per kilogram (mg/kg) administered subcutaneously (SC) once every 3 weeks (Q3W) for a total of 4 doses.

Peginesatide starting dose of 0.15 mg/kg administered SC Q3W for a total of 4 doses.

Peginesatide starting dose of 0.2 mg/kg administered SC Q3W for a total of 4 doses.

Peginesatide starting dose of 0.05 mg/kg administered SC Q3W for a total of 4 doses.

peginesatide

Affymax

The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple subcutaneously administered injections of peginesatide in anemic cancer participants receiving chemotherapy.

This was a Phase 2, open-label, multi-center, sequential dose finding study with up to 6 treatment cohorts receiving chemotherapy with 15 participants per cohort. The primary objective of this study was to determine the dose of peginesatide administered every 3 weeks (Q3W) by subcutaneous injection associated with a hemoglobin increase of ≥ 1 g/dL in ≥ 50% of anemic cancer participants receiving chemotherapy at 9 weeks following the first dose.

Study of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy

A Phase 2, Open-Label, Multi-Center Dose Escalation Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Precancerous Conditions

Pharmaceutical Solutions

Lenograstim

Darbepoetin alfa

solution for subcutaneous injection , syringe 500 mcg and 300 mcg respectively

solution for subcutaneous injection, 500 mcg

Aranesp and Neupogen G-CSF (Neupogen) 300 mcg s.c. twice a week, 3-4 days apart and EPO (Aranesp) 500 mcg s.c. once every 2 weeks until week 24, titrate depending of response

Darbepoetin and Filgrastim

Aranesp EPO (Aranesp) 500 mcg s.c. once every 2 weeks until 24 weeks, titrate depending of response

Darbepoetin

Samir G Agrawal, MD, PhD

Myelodysplastic syndromes (MDS) are acquired clonal disorders of the bone marrow. The clinical consequences of MDS are bone marrow failure and a predisposition to develop acute myeloid leukaemia (AML). Patients with 'low risk MDS' have less than 10% myeloblasts in the marrow and include the World Health Organization (WHO) subtypes refractory anaemia (RA), refractory anaemia with ring sideroblasts (RARS) and refractory anaemia with excess blasts-I (RAEB-I). This group of patients has a relatively low risk of leukaemic transformation and the major clinical problem is the manifestation of bone marrow failure. Up to 80% of these patients become red cell transfusion dependent. To date, the only curative therapy is allogeneic stem cell transplantation. Unfortunately, a median age at diagnosis of \> 65 years excludes this type of therapy for most patients with MDS. The aim of treatment is, therefore, supportive therapy. Long term red cell transfusion therapy carries the problems of acute transfusion reactions: iron overload, alloantibody formation, poor venous access and the risk of transfusion transmitted infection. With time, such patients require increasing frequency of transfusion and obtain decreased length of benefit from transfusion. The quality of life of such patients is significantly reduced. Alternative therapies, therefore, aimed at promoting more effective haemopoiesis and reducing the need for red cell transfusion may improve quality of life, reduce the use of expensive resources such as red cells and iron chelation, and perhaps enhance survival.

Combined darbepoetin alfa (Aranesp) plus G-CSF (Neupogen; filgrastim) in low risk MDS is better than best supportive care, with respect to haemoglobin and quality of life. The study will assess:

* the costs of this approach
* long-term outcomes
* clinical/laboratory parameters allowing early cessation of therapy in patients destined not to respond

STUDY OBJECTIVES:

Primary objectives:

* To compare the Quality of Life of Low-risk MDS patients randomised to receive prolonged treatment with EPO alone, EPO with G-CSF or best supportive care alone.

Secondary objectives:

* To compare the haemoglobin response and transfusion requirements of patients in each of these arms.
* To compare the economics costs of treating patients in each arm, in order to derive a cost:benefit analysis.
* To assess the utility of prognostic factor and predictive factor assessment, in particular against the predictive model proposed by Hellstrom-Lindberg.

STUDY DESIGN:

This trial is a multi-centre, randomised, triple arm, open-label trial of EPO alone (with best supportive care), EPO plus G-CSF (with best supportive care) and best supportive care only in patients with low-risk myelodysplastic syndrome with symptomatic anaemia and/or red cell transfusion dependence. Screening procedures will take place within 42 days of randomisation.

Patients will be randomised in a 1:1:1 ratio to EPO and best supportive care, EPO with G-CSF and best supportive care, or best supportive care only. Patients randomised to drug therapy arms will receive EPO subcutaneously every fortnight ± G-CSF at least weekly, together with red cell transfusions and other supportive care if required. Patients randomised to "best supportive care" only will receive red cell transfusions and supportive care as required. Study visits and selected study investigations will occur every 4 weeks for the first 24 weeks, then at 36 and 52 weeks.

Quality of life (FACT-An and EQ-5D) measures will be used for all arms of the study.

Analysis \& Reporting:

Data will be analysed and reported for all endpoints after the final patient has completed the 52 week follow-up.

Data Monitoring Committee:

An independent Data Monitoring Committee (DMC) will ensure the safety of patients enrolled in the trial. This group will be the MRC Leukaemia LDMEC (Chair: Prof. Gordon Murray). The DMC will meet at the commencement of recruitment and will formulate its guidelines for safety and efficacy monitoring. The DMC will provide a report of their meetings to the TSC. The DMC will meet at least annually and more frequently if needed.

Central Morphology Review:

Bone marrow biopsies/aspirates for all patients will be sent for central morphology review to determine eligibility for the study. All screening aspirates and biopsies will be reviewed centrally to confirm the diagnosis of MDS and the categorisation of the WHO/FAB subtype. On-study and end of study bone marrows will also be reviewed. In addition, centralised testing of specialist investigations will be performed.

STUDY ENDPOINTS:

Primary end point:

* Quality of life at 24 weeks (FACT-An \& EQ-5D - the latter for use in health economic analyses)

Secondary end points:

* Quality of life at 12, 36 and 52 weeks (FACT-An \& EQ-5D)
* Overall erythroid response (major and minor) at 24 weeks (main analysis point) and also at 12 and 52 weeks, as defined by the International Working Group (IWG) criteria
* Incidence of disease progression (i.e. to RAEB or AML)
* Overall survival
* Economic costs of managing anaemia in each arm of the study.

STUDY DURATION:

Patients will be monitored for all study endpoints up to 52 weeks. Patients responding to EPO ± G-CSF will remain on therapy for 52 weeks. Beyond 52 weeks, patients will be followed up indefinitely in order to assess duration of response, incidence of disease progression and overall survival (through the Office of National Statistics).

TOTAL SAMPLE SIZE:

Three hundred \& sixty(360) patients, one hundred \& twenty (120) in each arm.

DOSING REGIMEN:

The treatment schedule uses the concept of 'frontloading' to give patients the highest doses of EPO at the start of therapy in order to induce a response as quickly as possible. The long-acting nature of darbepoetin alpha avoids excessive frequency of injections, but allows delivery of high doses of EPO. At week 24, if no response is achieved, the study treatment is deemed to have failed and is stopped and patients will receive 'best supportive care' only.

Darbepoetin (120 patients):

* EPO (Aranesp®) 500 mcg s.c. once every 2 weeks.

  1. If a rapid response is obtained (Hb increase \> or = 2 g/dl in any 4 week period), titrate down the dose frequency of EPO.
  2. If major response, titrate EPO to lowest dose frequency that maintains the response.
* At 24 weeks :

  1. If no response, stop EPO and give supportive therapy only.
  2. If minor response, continue EPO 500 mcg once every 2 weeks s.c.
  3. If major response, titrate EPO to lowest dose frequency that maintains the response.

Darbepoetine with Filgrastim (120 patients):

* G-CSF (Neupogen®) 300 mcg s.c. twice a week, 3-4 days apart.
* EPO (Aranesp®) 500 mcg s.c. once every 2 weeks.

  1. If a rapid response is obtained (Hb increase \> or = 2 g/dl in any 4 week period), titrate down the dose frequency of EPO.
  2. If major response, titrate EPO and G-CSF to lowest dose frequency that maintains the response.
* At 24 weeks :

  1. If no response, stop EPO and G-CSF and give supportive therapy only.
  2. If minor response, continue EPO 500 mcg every 2 weeks s.c. and G-CSF 300 mcg s.c. twice a week, 3-4 days apart.
  3. If major response, titrate EPO and G-CSF to lowest dose frequency that maintains the response.

Best Supportive Care (120 patients):

Patients randomised to no growth factor treatment will receive best supportive care, defined as:

* Red cell transfusion support to achieve a predicted post-transfusion haemoglobin of 11.0 to 12.0 g/dl at a quantity \& frequency such that the trough haemoglobin is never \< 8.0 g/dl OR

  * such that the patient is never excessively symptomatic, according to local transfusion guidelines/policy.

STUDY DRUG SUPPLIES:

Darbepoetin (Aranesp®) pre-filled syringes 500 mcg and filgrastim (Neupogen®) pre-filled syringes 300 mcg will be supplied by Amgen (UK)and provided free of charge.

SAFETY ASSESSMENTS:

* Vital signs
* Physical examination
* Clinical laboratory assessments
* Concomitant medications
* Adverse events

EFFICACY ASSESSMENTS:

* Quality of life assessments
* Number and frequency of red cell transfusions
* Clinical laboratory assessments
* Bone marrow aspirate assessments

Erythropoietin (EPO) and Granulocyte-Colony Stimulating Factor (G-CSF) for Low-Risk Myelodysplastic Syndromes (MDS)

A Randomised Controlled Trial of Prolonged Treatment With Darbepoetin Alpha With or Without Recombinant Human Granulocyte Colony Stimulating Factor (G-CSF) Versus Best Supportive Care in Patients With Low-Risk Myelodysplastic Syndromes

St. Bartholomew's Hospital

Dr. S. Agrawal

Kidney Diseases

Kidney Failure, Chronic

Renal Insufficiency

Renal Insufficiency, Chronic

Urologic Diseases

Male Urogenital Diseases

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Single injection administered intravenously

Single peginesatide dose of 0.025 milligram per kilogram (mg/kg) administered intravenously.

Single peginesatide dose of 0.05 mg/kg administered intravenously.

Single peginesatide dose of 0.10 mg/kg administered intravenously.

Placebo

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and minimum pharmacologically active dose of peginesatide in Healthy Volunteers.

This was a Phase 1, double-blind, placebo-controlled trial of peginesatide, an erythropoiesis stimulating agent, with approximately 7 treatment cohorts and 7 healthy volunteer participants per cohort. In each cohort of 7 participants, a ratio of 5:2 participants was randomly assigned to receive a single dose of peginesatide or placebo, respectively, administered as an intravenous infusion. Planned peginesatide dose levels were to escalate by cohort. The study was conducted at a single clinical center.

Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers

A Phase 1, Double-blind, Placebo-controlled, Dose Escalation Study of the Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers

Cytopenia

Panobinostat

Histone Deacetylase Inhibitors

Enzyme Inhibitors

During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.

During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.

LBH589 was supplied at dose strengths of 5 mg or 20 mg hard gelatin capsules.

LBH589

Epoetin alfa was supplied as 10000 IU/1 mL in a ready-to-use syringe.

This study assessed the efficacy and safety of LBH589 as single agent and in combination with ESA in red blood cell transfusion-dependent Low and Int-1 MDS patients being either refractory to ESA or with a low probability of response. The study had a non-randomized core phase followed by a randomized phase.

LBH589 Alone or in Combination With Erythropoietin Stimulating Agents (ESA) in Patients With Low or Int-1 Risk Myelodysplastic Syndromes (MDS)

A One Year, Open Label, Multicenter Trial of LBH589 Alone or in Combination With ESA in Red Blood Cell Transfusion-dependent LOW and INT-1 MDS Patients Being Either Refractory to ESA or With a Low Probability of Response - the GErman PAnobinostat Low Risk MDS Trial - GEPARD Study

HI-E was assessed according to the modified international working group (IWG) criteria for HI. Erythroid response (pretreatment, \<11 g/dL): Hgb increase by ≥ 1.5 g/dL, relevant reduction of units of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 wk compared with the pretreatment transfusion number in the previous 8 wk, and only RBC transfusions given for a Hgb of ≤ 9.0 g/dL pretreatment were counted in the RBC transfusion response evaluation; Platelet response (pretreatment, \< 100 x 109/L): absolute increase of ≥ 30 x 109/L for participants starting with \> 20 x 109/L and platelets Increase from \< 20 x 109/L to \> 20 x 109/L and by at least 100%; Neutrophil response (pretreatment, \< 1.0 x 109/L): at least 100% increase and an absolute increase \> 0.5 x 109/L; Progression or relapse after HI: At least 1 of the following: At least 50% decrement from maximum response levels in granulocytes or platelets, reduction in Hgb by ≥1.5 g/dL, or transfusion dependence.

Objective response (complete remission (CR) + partial remission (PR) and HI-platelet (HI-P) response + HI-neutrophil (HI-N) response) was assessed according to the modified IWG criteria: CR bone marrow with 5% myeloblasts with normal maturation of al cell lines (persistent dysplasia is noted) and peripheral blood with Hgb \>= 11 g/dL platelets \>=100 X 10\^9/L, neutrophils \>= 1.0 x 10\^9/L and blasts 0%. PR = All CR if abnormal before treatment except bone marrow blasts decreased by\>=50% over pretreatment but still \>5% (ellularity and morphology not relevant). HI-P (pretreatment, \< 100 x 109/L) = absolute increase of ≥ 30 x 109/L for participants starting with \> 20 x 109/L and platelets Increase from \< 20 x 109/L to \> 20 x 109/L and by at least 100%; HI-N (pretreatment, \< 1.0 x 109/L) = at least 100% increase and an absolute increase \> 0.5 x 10\^9/L.

The IPSS score values were calculated based on the results of bone marrow analysis. A score value of 0 has bone marrow blast \<5%, karyotype of normal, sole: -Y, del 5Q, del 20q and cytopenias (lineages affected) of 0 to 1. Score value of 0.5 has 5-10 bone marrow blasts, karyotype of Others and cytopenias of 2 to 3. A score value of 1.0 has complex \>= 3 chromosomal abnormalities and/or chromosome 7 anomalies. A score of 1.5 has 11-20 bone marrow blasts and a score of 2.0 has 21-30 bone marrow blasts. The prognostic score is determined by the sum of the single scoring values. The risk groups are determined as follows: Low = 0 points (5.7 years of median survival); intermediate -1 (INT-1) = 0.5-1.0 points (3.5 years of median survival); INT-2 = 1.5-2.0 points (1.2 years of median survival); and high \>=2.5 points (6 months of median survival).

OS was defined as the time from start of treatment to death from any cause.

Time to response was defined as the time from start of treatment to the first documented response (complete \[CR\] or partial \[PR\]) according to modified IWG criteria for HI.

EFS was defined as the time from start of treatment to failure or death from any cause.

PFS was defined as the time from start of treatment to disease progression or death from MDS.

DFS was defined as the time from start of treatment to the time to relapse.

Time to cause-specific death was defined as the time from start of treatment to death related to MDS.

LBH589 - Core Phase

LBH589 - Randomized Phase

LBH589 + ESA - Randomized Phase

Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.

Not Randomized

Age, Continuous

Sex: Female, Male

Study Director

Participants from the core phase, who had valid response data, were analyzed.

Percentage of Participants With Hematological Response of the Erythropoetic System (HI-E) - Core Phase

32 weeks (n=5,1,1)

52 weeks (n=4,3,1)

LBH589 + Epoetin Alfa

Participants from the randomized phase, who had valid response data, were analyzed.

Percentage of Participants With HI-E - Randomized Phase

Participants from the core phase, who had valid data, were analyzed.

Percentage of Participants With Objective Response During Core Phase

Week 32 ( n=5,1,1)

Week 48 (n=6,5,1)

Participants from the randomized phase, who had valid data, were analyzed.

Percentage of Participants With Objective Response During the Randomized Phase

Baseline (core phase), Low

Baseline (core phase),, INT-1

Baseline (core phase),, INT-2

Baseline (core phase), High

All participants from the core phase were analyzed.

Frequency Distribution of IPSS Score Status - Core Phase

Week 52 (randomized phase), Low

Week 52 (randomized phase), , INT-1

Week 52 (randomized phase), INT-2

Week 52 (randomized phase), HIgh

Only participants from the randomized phase, who had values at week 52, were included in the analysis.

Frequency Distribution of IPSS Score Status - Randomized Phase

Mean Single Scoring Values of the IPSS - Core Phase

Participants from the randomized phase, who had values at week 52, were included in the analysis.

Mean Single Scoring Values of the IPSS - Randomized Phase

Overall Survival (OS) - Overall Period

Time to response could not be evaluated because there was no response.

Time to Response - Overall Period

Event-free survival could not be evaluated because there was no response, no progression or no disease-free period.

Event-free Survival (EFS) - Overall Period

PFS could not be evaluated because there was no progression.

Progression-free Survival (PFS) - Overall Period

DFS could not be evaluated because there was no disease-free period.

Disease-free Survival (DFS) - Overall Period

Time to cause-specific death could not be evaluated because there was no cause-specific death.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pharmacokinetics of Patupilone After a Single Intravenous Administration in Patients With Advance Solid Tumor Malignancies.	NCT00426140	Advanced Malign... Solid Tumors	Patupilone	18 Years -	Novartis
Use of FACT-GOG/NTX Questionnaire in Peripheral Neurotoxicity & Validation of a French Version of This Questionnaire	NCT00517621	Ovarian Cancer Fallopian Tube ... Peritoneal Neop...	Paclitaxel EPO	18 Years -	ARCAGY/ GINECO GROUP
Study of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy	NCT00272662	Chemotherapy In... Cancer	peginesatide	18 Years - 80 Years	Affymax
Pharmacokinetics of Patupilone After a Single Intravenous Administration in Patients With Advance Solid Tumor Malignancies.	NCT00426140	Advanced Malign... Solid Tumors	Patupilone	18 Years -	Novartis
Erythropoietin (EPO) and Granulocyte-Colony Stimulating Factor (G-CSF) for Low-Risk Myelodysplastic Syndromes (MDS)	NCT00234143	Myelodysplastic...	Darbepoetin and... Darbepoetin	18 Years -	St. Bartholomew's Hospital
Safety and Pharmacokinetics of Single Intravenous Doses of Peginesatide in Healthy Volunteers	NCT00097747	Anemia Chronic Kidney ... Chronic Renal F... Cancer	Placebo peginesatide	18 Years - 40 Years	Affymax
LBH589 Alone or in Combination With Erythropoietin Stimulating Agents (ESA) in Patients With Low or Int-1 Risk Myelodysplastic Syndromes (MDS)	NCT01034657	Myelodysplastic...	LBH589 Epoetin Alfa	18 Years -	Novartis
Study of Patupilone in Patients With Brain Metastasis From Non-small Cell Lung Cancer	NCT00219297	Brain Metastasi... Non-small Cell ...	Patupilone	18 Years -	Novartis
Pharmacokinetics of Patupilone After a Single Intravenous Administration in Patients With Advance Solid Tumor Malignancies.	NCT00426140	Advanced Malign... Solid Tumors	Patupilone	18 Years -	Novartis
Erythropoietin (EPO) and Granulocyte-Colony Stimulating Factor (G-CSF) for Low-Risk Myelodysplastic Syndromes (MDS)	NCT00234143	Myelodysplastic...	Darbepoetin and... Darbepoetin	18 Years -	St. Bartholomew's Hospital
LBH589 Alone or in Combination With Erythropoietin Stimulating Agents (ESA) in Patients With Low or Int-1 Risk Myelodysplastic Syndromes (MDS)	NCT01034657	Myelodysplastic...	LBH589 Epoetin Alfa	18 Years -	Novartis

Spots Global Cancer Trial Database for epo

Every month we try and update this database with for epo 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 epo

Every month we try and update this database with for epo 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 epo 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.