Advertisement

Topics

A Phase I/II Study of CP-4055 in Patients With Refractory/Relapsed Hematologic Malignancies

2014-07-23 21:34:33 | BioPortfolio

Summary

Patients with refractory or relapsed hematologic malignancies will receive CP-4055 intravenously(IV) on Day 1-5 every three weeks until complete response or disease worsening/progressing

Description

This is a multicentre clinical study conducted in the USA and in Europe. It is an open label, dose escalation study designed to characterize the safety, tolerability, pharmacokinetics (PK), and efficacy of CP-4055 as a single agent when administered as a 2 hours intravenous (IV) or a continuous IV (CIV) infusion administered daily for 5 days in a 21-day cycle, either alone or with idarubicin IV, in patients with refractory/relapsed hematologic malignancies who have either failed potentially curative therapy or are considered unsuitable for standard therapy.

In a second phase of the study the efficacy of single agent CP-4055 in patients with AML may be assessed.

It is intended that patients receive a minimum of two cycles of therapy in the absence of unacceptable toxicity or significant disease progression.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Hematologic Malignancies

Intervention

CP-4055, CP-4055

Location

Mew York Medical College, Division of Oncology
Valhalla
New York
United States
10595

Status

Active, not recruiting

Source

Clavis Pharma

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:34:33-0400

Clinical Trials [653 Associated Clinical Trials listed on BioPortfolio]

A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer

This is non randomised, open label, dose finding, efficacy and safety study, enrolling patients with advanced (stage III and IV) ovarian cancer It will be conducted in two successive phase...

A Phase II Study of CP-4055 as Second Line Therapy in Patients With Advanced Colorectal Cancer

Patients with histologically or cytologically confirmed metastatic colorectal cancer (CRC) who have failed a first-line chemotherapeutic regimen containing oxaliplatin and 5-fluorouracil (...

Multicentre, Dose Finding, Ph II,CP-4055 in Comb. With Sorafenib - Patients With Metastatic Malignant Melanoma

Patients with metastatic malignant melanoma will receive CP-4055 200 mg/m2/day intravenously (IV) on Day 1-5 every four weeks and sorafenib 400 mg b.i.d. (twice daily) every day until comp...

Clinical Study of Previously Untreated Patients With Malignant Melanoma

Previously untreated patients with malignant melanoma receive a new chemotherapy drug currently under development. CP-4055 is given intravenously on days 1-5 every four weeks until comple...

A Trial of TTI-621 for Patients With Hematologic Malignancies

Multicenter, open-label, Phase 1a/1b trial of TTI-621 in subjects with relapsed or refractory hematologic malignancies.

PubMed Articles [997 Associated PubMed Articles listed on BioPortfolio]

Urgent Chemotherapy in Sepsis-Like Shock Related to Hematologic Malignancies.

Hematologic malignancies may result in multiple organ involvement including pulmonary and renal dysfunctions, and the less common acute circulatory failure. We herein addressed the outcome of patients...

The Critical Role of Inflammation in the Pathogenesis and Progression of Myeloid Malignancies.

Hematopoietic stem cells (HSCs) maintain an organism's immune system for a lifetime, and derangements in HSC proliferation and differentiation result in hematologic malignancies. Chronic inflammation ...

Acute Acalculous Cholecystitis in Hospitalized Patients With Hematologic Malignancies and Prognostic Importance of Gallbladder Ultrasound Findings.

Patients with hematologic malignancies, especially those with acute disease or those receiving intense chemotherapy, are known to develop acute acalculous cholecystitis (AAC). The aim of this study wa...

Intensity of End-of-Life Care for Patients with Hematologic Malignancies and the Role of Race/Ethnicity.

Racial/ethnic minority patients with nonhematologic malignancies (non-HM) have lower rates of hospice care, advance directive use, and palliative care utilization than non-Hispanic white (NHW) patient...

Hematologic Malignancies Associated With Mediastinal Germ Cell Tumors: 10 Years' Experience at Thailand's National Pediatric Tertiary Referral Center.

Mediastinal germ cell tumor (MGCT), which accounts for 1% to 3% of extragonadal germ cell tumors, has unique manifestations; it is associated with several types of hematologic malignancy, particularly...

Medical and Biotech [MESH] Definitions

An alkylating agent of value against both hematologic malignancies and solid tumors.

The co-occurrence of pregnancy and a blood disease (HEMATOLOGIC DISEASES) which involves BLOOD CELLS or COAGULATION FACTORS. The hematologic disease may precede or follow FERTILIZATION and it may or may not have a deleterious effect on the pregnant woman or FETUS.

A hematopoietic growth factor which promotes proliferation and maturation of neutrophil granulocytes. Clinically it is effective in decreasing the incidence of febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive therapy or in reducing the duration of neutropenia and neutropenia-related clinical sequelae in patients with non-myeloid malignancies undergoing myeloblastive chemotherapy followed by BMT. It has also been used in AIDS patients with CMV retinitis being treated with GANCICLOVIR. (Gelman CR, Rumack BH & Hess AJ (eds): DRUGDEX(R) System. MICROMEDEX, Inc., Englewood, Colorado (Edition expires 11/30/95))

Disorders of the blood and blood forming tissues.

Tests used in the analysis of the hemic system.

More From BioPortfolio on "A Phase I/II Study of CP-4055 in Patients With Refractory/Relapsed Hematologic Malignancies"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Cancer
  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...


Searches Linking to this Trial