Pharmatech's Active Clinical Trial Listing

ANEMIA

Protocol: NE-180-201

An Open-label, Sequential, Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Dose Response of Fixed, Repeated Doses of NE-180 (GlycoPEGylated™ rHuEPO) in Anemic Cancer Patients Receiving Chemotherapy

Eligibility:

• Male or female patients must be ≥ 18 and ≤ 80 years of age at the time of consent
• Patients must have a body weight ≥ 40 and ≤ 90 kg
• Patients must have a diagnosis of a histological-confirmed solid tumor or non-myeloid malignancy
• Patients must be on a 4-6 cycle regimen of myelosuppressive chemotherapy (platin– or non-platin-based chemotherapy is permitted) with a dosing schedule of every three weeks. Upon enrollment to the Treatment phase (Week 0), patients are expected to receive at least 4 additional cycles of chemotherapy.
• Patients must have anemia defined as baseline hemoglobin level of ≥ 9.0 and ≤ 11.0 g/dL within one week prior to administration of study drug
• Patients are expected to be treated with intravenous (IV) iron throughout the Treatment phase
• Patients must have an Eastern Cooperative Oncology (ECOG) performance status of 0, 1, or 2
• Patients must have a life expectancy of 6 months or more
• If female, the patient must be postmenopausal, surgically sterilized, or practicing an acceptable method of contraception

BREAST

Protocol: E7389-G000-301

A Phase III Open Label, Randomized Two-Parallel-Arm Multicenter Study of E7389 versus Capecitabine in Patients with Locally Advanced or Metastatic Breast Cancer Previously Treated with Anthracyclines and Taxanes and Refractory to the Most Recent Chemotherapy

Eligibility:

• Female patients with histological or cytological carcinoma of the breast. Every effort should be made to ensure that paraffin embedded tissue or slides from the diagnostic biopsy or surgical specimen are available for confirmation of diagnosis.
• Patients with locally advanced or metastasis disease who have received up to three prior chemotherapy regimens, and no more than two prior regimens for advanced disease. The regimens must have included an anthracycline and a taxane.
• Resolution of all chemotherapy or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy ≤ Grade 2 and alopecia
• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Life expectancy of ≥ 3 months
• Adequate renal, bone marrow, and liver function
• Patients willing and able to complete the EORTC quality of life questionnaire (QLQ-C30 with breast cancer module QLQ-BR23) and Pain VAS
• Patients willing and able to comply with the study protocol for the duration of the study
• Written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice

CHRONIC MYELOGENOUS LEUKEMIA

Protocol: 3160A4-3000-WW

A Phase 3 Randomized, Open-Label Study of Bosutinib versus Imatinib in Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myelogenous Leukemia

Eligibility:

• Chronic phase Ph+ CML, diagnosed for ≤ 6 months
• Treatment-naive, no prior anti-leukemia treatment allowed (including stem cell transplant)
• Patient is ≥ 18 years of age at the time informed consent is provided
• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Patient has no cardiac issues, HIV, hepatitis B, hepatitis C, cirrhosis, or GI disorders

NON-SMALL CELL LUNG CANCER

Protocol: 056-01

A Phase II/III Randomized, Double-Blind Study of Paclitaxel plus Carboplatin in Combination with Vorinostat (MK-0683) or Placebo in Patients with Stage IIIB (with pleural effusion) or Stage IV Non-Small-Cell Lung Cancer (NSCLC)

Eligibility:

• Patient has a histological or cytological confirmed diagnosis of Stage IIIB (with pleural effusion) or Stage IV NSCLC
• Patient has received no prior systemic chemotherapy, with the exception of adjuvant chemotherapy for NSCLC. If the patient has received prior adjuvant chemotherapy for NSCLC, it must have been completed 12 months or more prior to study enrollment.
• Patient is ≥ 18 years of age at the time informed consent is provided
• Patient has measurable disease
• Patient is at least 3 weeks from any prior major surgery or radiation therapy and has adequately recovered from the toxicity and/or complications of these interventions
• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1
• Patients has adequate organ function as indicated by the System Laboratory Values

SARCOMA

Protocol: SMI-BRS-202

A Phase II, Multicenter Context of Vulnerability Study to Determine the Activity of Brostallicin in the treatment of Patients with Myxoid Liposarcoma with (12;16) Translocation

Eligibility:

• Patient has a histological confirmed myxoid liposarcoma with the presence of a (12;16) translocation documented prior to treatment
• Patient has myxoid liposarcoma that is metastatic or unrespectable and for which standard curative or palliative measures do not exist or are no longer effective, in the judgment of the Investigator
• Patient is ≥ 18 years of age at the time informed consent is provided
• Life expectancy of at least 3 months
• Patient has measurable tumor on CT, spiral CT, or MRI scan which is classifiable according to RECIST criteria
• Acceptable liver and renal function
• Acceptable hematologic status