Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Lipid Regulating Agents

All Drugs and Chemicals

Pravastatin

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Enzyme Inhibitors

Healthy volunteer female subjects of non-childbearing potential will be administered pravastatin once on Day 1 during Period 1 (Day -1 to Day 4). During Period 2 (Days 5-28) GDC-0810 will be administered daily on Days 5-8. Pravastatin will be co-administered on Day 7.

During Period 2 subjects will be administered an oral 600 mg dose GDC-0810 daily beginning on Day 5 for 4 consecutive days (from Days 5 to 8, inclusive).

GDC-0810

Subjects will receive a single oral dose of 10 mg pravastatin on Day 1 in Period 1 and Day 7 in Period 2.

Clinical Trials

This study is to assess the pharmacokinetics (PK) of a single dose of pravastatin with and without concomitant GDC-0810 administration in healthy female subjects of non-childbearing potential. During Period 1 (Day -1 to Day 4) PK parameters of pravastatin will be determined in the absence of GDC-0810. During Period 2 (Days 5-28) PK parameters of pravastatin will be determined in the presence of GDC-0810.

Effect of GDC-0810 on the Pharmacokinetics of Pravastatin in Healthy Female Subjects of Non-Childbearing Potential

A Phase 1, Open-Label Study to Evaluate the Effect of GDC-0810 on the Pharmacokinetics of Pravastatin in Healthy Female Subjects of Non-Childbearing Potential

Genentech, Inc.

Blood and Lymph Conditions

Leukemia

Neoplasms by Histologic Type

Hematologic Diseases

Antineoplastic Agents

Bortezomib

Patients who have received a Stem cell transplant for Hematologic malignancies will be monitored for signs of relapse with blood tests for CD34+ chimerism. Patients with signs of relapse will have bone marrow aspirate and/or other appropriate tests to confirm presence of relapse. All patients who are confirmed to have relapsed and meet eligibility criteria to receive study drug will be eligible to receive treatment on the treatment arm.

Patients with confirmed disease will initiate therapy with bortezomib and pravastatin, a regimen that has efficacy in treatment of leukemia and graft-versus-host disease, while sparing healthy donor hematopoietic stem cells may improve the dismal survival of relapse post allogeneic transplant. Depending on response, patients may receive up to 13 cycles of therapy

1.3 mg/m2/dose subcutaneously (SQ) daily (total 4 doses) on Days 1, 4, 8 and 11 (+/- 1 day with at least 72 hours between doses) q3 weeks. (For patients continuing to receive drug in cycles 6 or greater, at investigator discretion, the schedule may be changed to 1.3 mg/m2/dose SQ daily (total 3 doses) on Days 1, 8, and 15 (+/- 1 day with at least 72 hours between doses) every 4 weeks in an effort to decrease risk of peripheral neuropathy.)

10 mg for age \< 8 years, 20 mg for age 8-\<13 years, 40 mg for ages \>14 years

Reuven Schore, MD

This study aims to monitor patients for relapse of the leukemia following allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in order to identify patients early in relapse, with a low burden of disease, when interventions may be more successful by monitoring of peripheral blood lineage specific chimerism. Once disease has been confirmed, patients will initiate a novel combination of bortezomib and pravastatin.

Patients will be enrolled on this study at the time of transplantation. Following HSCT, CD34+ chimerism in peripheral blood will be monitored in real time at scheduled intervals. If chimerism of CD34+ cells diminishes post-HSCT or clinical signs or symptoms of relapsed leukemia, relapse in bone marrow will be confirmed, after which immunosuppression will be withdrawn and treatment initiated with bortezomib and pravastatin. Patients will be monitored for disease response until 1 year post-HSCT or post-study therapy. Patients with confirmed relapse post-HSCT will also be eligible to enroll and receive novel combination.

Monitoring and Treatment of Relapsed Leukemia Following Allogeneic Hematopoietic Stem Cell Transplantation in Children

Pilot Study to Evaluate the Tolerability of Velcade (Bortezomib) and Pravastatin for the Treatment of Relapsed Leukemia Following Allogeneic Hematopoietic Stem Cell Transplantation in Children

Tolerability of bortezomib and pravastatin in pediatric relapsed leukemia patients following allogeneic transplantation

The sensitivity of detection of recurrent acute leukemia in pediatric patients by peripheral blood CD34+ chimerism in pediatric patients following allogeneic HSCT

Millennium Pharmaceuticals, Inc.

Hyundai Hope On Wheels

Reuven Schore

Symptoms and General Pathology

Behaviors and Mental Disorders

Fibrosis

Quality of Life

ePRO intervention + PRAVASTATINE treatment

Statements of symptoms and patients' health status (PROs) will be collected via a web interface, including access and use in patients with burden symptoms.

The platform will include four items concerning 7 side effects of fibrosis of grade \> 2 in breast cancer. Patients will be encouraged to evaluate on a 5-point Likert scale the frequency, the intensity and the repercussions on the daily life of some symptoms during the last 7 days, in particular on:

* general pain
* anxiety
* sadness
* texture of the treated breast
* Patients will also be invited to express themselves on the severity of two other symptoms of their choice, to their worst degree, by listing and rating them on a 5-point scale ranging from "None" to "Very severe" Finally, the aesthetic impact will be evaluated by patients on a visual analogue scale (VAS) of 0 to 100mm

e-PRO Intervention

All patients will take Pravastatin 40 mg per day (From Day 0 to Month 12).

BOURGIER MD CELINE

BLEUSE Jean-pierre

Conserving surgery followed by adjuvant radiotherapy is currently the therapeutic standard for patient with Breast Cancer. Symptoms are common among patients receiving this treatment. Ten percent of them will develop severe and chronic radio-induced toxicities, such as breast radio-induced-fibrosis impairing their quality of life (QoL). Yet, paying attention to symptom improves the empowerment and psychological adjustment to the disease. Web-based systems that can provide electronic-Patient reported Outcomes (e-PRO) have been shown to prompt clinicians to intensify symptom management, to improve symptom control, and to enhance patient-clinician communication patient satisfaction, as well as well-being.Benefits of systems to elicit e-PRO improve reliable measure of health-related quality of life (QoL) remains discussed.

To date, there are few specific treatments for these severe radio-induced fibrosis except the antifibrotic combinaison Pentoxifylline/Vitamin E with inconsistent result.

Since 2000, we and others have developed a mechanistic approach modulating the severity of RIF by targeting the Rho/ROCK/CTGF pathway, especially by inhibiting Rho activation by pravastatin. Our preclinical data, then followed by the Phase II PRAVACUR-01 trial, concluded that the use of pravastatin has an anti-fibrotic action on different experimental models and reduces the severity of the grade of fibrosis in 50% of patients.

Patients can now benefit from this new anti-fibrotic agent.

Taken as a whole, these data encourage combining both drug (pravastatin) and non-pharmacological intervention , in particular e-PRO, in the RIF management.

Improving Theempowerment in Patients With Severe Breast Fibrosis Radio-induced Treated by Pravastatin : Benefit of e-PROs (Electronic " Patient Reported Outcome ") on Breast-related Quality of Life

The BRQoL improvement rate at 12 months, compared with baseline, defined as:

* an improvement of 5 points (or more) of the score assessed by the functional scale "body image" of the QLQ-BR23 (summary score including the items # 39-42), or
* a reduction of 5 points (or more) of the score on the symptom scale "breast symptoms" assessed by the QLQ-BR23 (summary score including the items # 51- 53).

defined by the Health-related quality of life assessed by the EORTC QLQ-C30 and its module BR23

defined by the rate and dose of used antidepressants

defined by the rate and dose of used analgesics

defined by the rate and dose of used anxiolytics

assessed by (HADS) Scale : score {min :0 (no Distress) --- max :21 ( Hight Distress) }

Timing of the e-PROs alerts and the care management (phone call or planning of a consultation, treatment initiation)

Evolution of the 7 different e-PROs scores across time (general pain { 0 (no pain)- 4 (high pain)}, anxiety{ 0 (no anxiety)- 4 (high anxiety)}, sadness { 0 (no sad)- 4 (high sad)}, texture of the treated breast{ 0 (no sweeling)- 4 (high sweeling)}, two other symptoms assessed by the PRO-CTCAE scales { 0 (none)- 4 (severe)}, and scores of aesthetic impact assesses by a Visual Analog Scale{ 0 (no impact)- 100 (max impact)}

Number of hospital emergency visits or hospitalizations

Regression rate of at least 1 grade of fibrosis (follow-up of fibrosis grade evolution since inclusion)

Relapse-free survival defined as the time from the date of randomization to the date of the first observed oncological event such as local, ipsilateral, regional or metastatic recurrence or death for any cause

Institut du Cancer de Montpellier - Val d'Aurelle

Digestive System Diseases

Carcinoma, Hepatocellular

Carcinoma

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Sorafenib

The treatment received will be sorafenib 400 mg/12 h + pravastatin 40 mg/24 h.

The treatment received will be sorafenib 400 mg/12 h + placebo/24 h.

Treatment:

Patients will be randomized in two groups, A and B:

* Control Group (A ≡ 1): Patients will receive treatment with sorafenib 400 mg/12 h + placebo/24 h.
* Experimental Group (B ≡ 2): The treatment received will be sorafenib 400 mg/12 h + pravastatin 40 mg/24 h.

Juan I Arenas, MD,PHD

Javier Bustamante Scheneider, MD

Trinidad Serrano Aullo, MD, PHD

Mercedes Iñarrairaegui Bastarrica, MD

Sonia Blanco Sampascual, MD

Maria Varela, MD, PHD

Oscar Nuñez, MD

The purpose of this study is to evaluate the overall survival (OS) in order to assess the efficacy and safety of pravastatin as adjuvant treatment to sorafenib.

Efficacy and Safety Study of Sorafenib Plus Pravastatin to Treat Advanced Hepatocarcinoma

Phase-II, Multicenter, Randomized, Double-Blind, Parallel-Group Trial to Compare the Efficacy and Safety of Sorafenib Plus Pravastatin Against Sorafenib Plus Placebo in Patients With Advanced Hepatocarcinoma

To evaluate the overall survival (OS) in order to assess the efficacy and safety of pravastatin as adjuvant treatment to sorafenib.

To evaluate the time to progression (TTP).

To evaluate the time to symptomatic progression (TTSP).

INSTITUTO BIODONOSTIA

Hospital Donostia

MD. PHD

Diseases and Abnormalities at or Before Birth

Rare Diseases

Recurrence

Congenital Abnormalities

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

Cytarabine

Idarubicin

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Antibiotics, Antitubercular

cytarabine

idarubicin

pravastatin

Stephen H. Petersdorf, MD

RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Pravastatin may help idarubicin and cytarabine work better by making cancer cells more sensitive to the drugs. Giving pravastatin together with idarubicin and cytarabine may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of pravastatin when given together with idarubicin and cytarabine in treating patients with acute myeloid leukemia.

OBJECTIVES:

* Determine the biological efficacy of pravastatin in leukemia cells, in terms of measuring surrogate endpoints, including cellular cholesterol, messenger RNA encoding cholesterol synthesis, cholesterol import regulators, and specific protein farnesylation, in patients with acute myeloid leukemia.
* Determine whether increasing doses of pravastatin, when administered with idarubicin and high-dose cytarabine, produce increased apoptosis in leukemia cells of these patients.
* Determine the maximum tolerated dose (MTD) of pravastatin when administered with idarubicin and high-dose cytarabine in these patients.
* Determine whether the MTD of pravastatin is required to achieve the maximal biological effect on cholesterol metabolism in leukemia cells of these patients.

OUTLINE: This is an open-label, multicenter, dose-escalation study of pravastatin.

Patients receive oral pravastatin once daily on days 1-8, idarubicin IV over 30 minutes on days 4-6, and high-dose cytarabine IV continuously on days 4-7. Treatment repeats every 28-42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete remission (CR) may receive additional treatment with the same doses of study drugs over fewer days. These patients receive oral pravastatin once daily on days 1-6 and idarubicin IV over 30 minutes and high-dose cytarabine IV continuously on days 4 and 5. Patients experiencing disease response with severe side effects may receive additional treatment at a lower dose of the study drug causing the side effects.

Cohorts of 3 patients receive escalating doses of pravastatin until the maximum tolerated dose (MTD)\* is determined or a predetermined maximum dose is reached.

NOTE: \*Patients achieving a CR with a dose of pravastatin that is subsequently determined to be above the MTD receive pravastatin at the MTD for all subsequent courses.

After completion of study treatment, patients are followed at least every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 2 years.

Pravastatin, Idarubicin, and Cytarabine in Treating Patients With Acute Myeloid Leukemia

A Phase I Trial Evaluating the Effect of the Addition of HMGCoA-Reductase Inhibition With Pravastatin to Salvage Chemotherapy Idarubicin-HDAC in Patients With Relapsed or Refractory Acute Myelogenous Leukemia

Fred Hutchinson Cancer Center

Esophageal Neoplasms

Stomach Neoplasms

Disease Attributes

Head and Neck Neoplasms

Esophageal Diseases

Stomach Diseases

Esophageal Cancer

Stomach Cancer

Receive one tablet of 40 mg of pravastatin, orally every 24 hours (at breakfast) for 2 years.

Luis Bujanda, Prof.

The survival of esophageal cancer and stomach cancer (EGC) at 5 years is less than 30%. Pravastatin is a potent inhibitor of HMG-CoA reductase inhibitor that has shown increased survival in patients with advanced hepatocellular carcinoma. The objective is to evaluate the efficacy of treatment (increase in survival and recurrence-free period of the disease) with pravastatin in patients with advanced EGC. The investigators have designed a randomized, controlled and open. Advanced stage was considered for patients with T4 or N1 or M1 according to the TNM classification. It has been estimated sample size per treatment arm of 73 patients (146 patients in total). Randomization was done on a stratified by location (CE or CG). All patients receive hatitual treatment (surgery and / or chemotherapy and / or radiotherapy and / or palliative) for each of their clinical conditions. The experimental group will receive one tablet of 40 mg of pravastatin orally every 24 hours (breakfast) for 2 years. There will be a monthly monitoring of these patients for at least 2 years which includes an analytics. Every 2 months there will be an abdominal-pelvic CT scan to assess progression and treatment response.

1. Design: A randomized, controlled, open, parallel group study to assess the survival and disease-free period or progression in patients with advanced CGE over a period of 2 years.
2. Under study: Patients diagnosed in histology for the first time, advanced-stage CGE and fulfilling the inclusion criteria and none of the exclusion criteria proposed in the Hospital Donostia (San Sebastian) and Hospital de Basurto (Bilbao) .
3. Inclusion criteria: older than 18 years, esophageal or gastric cancer histologically confirmed (squamous or adenocarcinoma) for the first time, advanced stage (T4 or N1 or M1) according to the fourth edition of TNM classification and signing the informed consent
4. Exclusion criteria: Patients who routinely take (more than 3 days a week) anti-inflammatory drugs or aspirin, patients receiving oral anticoagulants, fibrates, cyclosporine and oral contraceptives, patients with hypersensitivity to pravastatin, pregnant women being lactation, peripheral neuropathy grade 2 or greater, patients who have been diagnosed in the previous 5 years other than skin cancer tumor that is not melanoma or carcinoma in situ of cervix or bladder, patients receiving chemotherapy or radiotherapy for other of tumor patients in their laboratory parameters before starting the present study transaminases or alkaline phosphatase more than twice the normal value, patients with platelet count less than 100.000/mm3, absolute neutrophil count below 1000/mm3, or patients with evidence of bleeding diathesis or coagulopathy, patients with heart failure than NYHA grade II, patients with creatinine greater than 2 mg / dL, patients over 75 years, asthmatics, patients with physical or mental disability, patients with alcoholism or patients with diseases hereditary muscle
5. Intervention: Patients were randomized to two groups:

   * Experimental Group: You will receive one tablet of 40 mg of pravastatin Cinfa EFG, orally every 24 hours (at breakfast) for 2 years.
   * Control Group: will not receive pravastatin. All patients receive the prescribed treatment (surgery and / or chemotherapy and / or radiotherapy and / or palliative) based on their stage and clinical situation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of GDC-0810 on the Pharmacokinetics of Pravastatin in Healthy Female Subjects of Non-Childbearing Potential	NCT02621957	Breast Cancer	GDC-0810 Pravastatin	18 Years - 65 Years	Genentech, Inc.
Monitoring and Treatment of Relapsed Leukemia Following Allogeneic Hematopoietic Stem Cell Transplantation in Children	NCT02484261	Leukemia	Bortezomib Pravastatin	22 Months - 21 Years	Children's National Research Institute
Improving Theempowerment in Patients With Severe Breast Fibrosis Radio-induced Treated by Pravastatin : Benefit of e-PROs (Electronic " Patient Reported Outcome ") on Breast-related Quality of Life	NCT04356209	Breast Cancer	e-PRO Intervent... Pravastatin	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle
Efficacy and Safety Study of Sorafenib Plus Pravastatin to Treat Advanced Hepatocarcinoma	NCT01418729	Advanced Hepato...	Pravastatin	18 Years - 100 Years	Hospital Donostia
Efficacy and Safety Study of Sorafenib Plus Pravastatin to Treat Advanced Hepatocarcinoma	NCT01418729	Advanced Hepato...	Pravastatin	18 Years - 100 Years	Hospital Donostia
Efficacy and Safety Study of Sorafenib Plus Pravastatin to Treat Advanced Hepatocarcinoma	NCT01418729	Advanced Hepato...	Pravastatin	18 Years - 100 Years	Hospital Donostia
Pravastatin, Idarubicin, and Cytarabine in Treating Patients With Acute Myeloid Leukemia	NCT00107523	Leukemia	cytarabine idarubicin pravastatin	18 Years -	Fred Hutchinson Cancer Center
Study to Evaluate the Efficacy of Pravastatin on Survival and Recurrence of Advanced Gastroesophageal Cancer	NCT01038154	Esophageal Canc... Stomach Cancer	Pravastatin	18 Years -	Hospital Donostia

Spots Global Cancer Trial Database for pravastatin

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

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