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Pralatrexate Medical Research Studies

Up-to-date List of Pralatrexate Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Pralatrexate Medical Research Studies

Rank Status Study
1 Recruiting Erlotinib in Combination With Pralatrexate in Advanced Malignancies
Conditions: Advanced Cancers;   Solid Tumors
Interventions: Drug: Erlotinib;   Drug: Pralatrexate
Outcome Measures: Maximum Tolerated Dose (MTD) of Erlotinib with Pralatrexate;   Tumor Response
2 Recruiting Study of Pralatrexate Versus Observation Following CHOP-based Chemotherapy in Previously Undiagnosed Peripheral T-cell Lymphoma Patients
Condition: Peripheral T-cell Lymphoma
Intervention: Drug: Pralatrexate Injection
Outcome Measures: Progression-free Survival (PFS);   Overall Survival (OS);   Objective Response to Pralatrexate versus Observation
3 Recruiting Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer
Conditions: Adenocarcinoma of the Esophagus;   Adenocarcinoma of the Gastroesophageal Junction;   Diffuse Adenocarcinoma of the Stomach;   Intestinal Adenocarcinoma of the Stomach;   Mixed Adenocarcinoma of the Stomach;   Recurrent Esophageal Cancer;   Recurrent Gastric Cancer;   Squamous Cell Carcinoma of the Esophagus;   Stage III Esophageal Cancer;   Stage III Gastric Cancer;   Stage IV Esophageal Cancer;   Stage IV Gastric Cancer
Interventions: Drug: Pralatrexate;   Drug: oxaliplatin;   Other: pharmacogenomic studies;   Genetic: RNA analysis;   Genetic: polymorphism analysis;   Genetic: polymerase chain reaction;   Genetic: microarray analysis;   Procedure: esophagogastroduodenoscopy;   Procedure: biopsy;   Other: laboratory biomarker analysis
Outcome Measures: Overall response rate to combination Pralatrexate and oxaliplatin as assessed by RECIST;   Toxicity as assessed by NCI CTCAE version 4.0;   Time to progression;   Overall survival;   To examine whether functionally relevant polymorphisms of genes of the folate metabolism pathway correlate with efficacy and toxicity of Pralatrexate.;   To examine whether response to Pralatrexate can be predicted by microRNA expression profiling of the epithelial component of the tumor.
4 Not yet recruiting Phase 2, Single Arm, Open Label Study of Folotyn in Combination With Oral Leucovorin to Prevent or Reduce Mucositis in Patients With PTCL
Conditions: Relapsed Peripheral T-Cell Lymphoma;   Refractory Peripheral T-Cell Lymphoma
Interventions: Drug: Folotyn and Leucovorin;   Drug: Folic Acid;   Drug: Vitamin B12
Outcome Measures: Grade 3 Oral Mucositis Prevention;   Grade 2 Oral Mucositis Prevention;   Effectiveness of Leucovorin in Folotyn dose modification;   Overall Response Rate
5 Recruiting Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies
Conditions: Lymphoid Malignancies;   Multiple Myeloma;   Lymphoma;   Hodgkin Lymphoma;   Non-hodgkin Lymphoma
Interventions: Drug: Pralatrexate;   Drug: Romidepsin
Outcome Measures: Phase I: Maximum tolerated dose (MTD) of the combination of Pralatrexate and romidepsin.;   Phase II: Overall response rate (ORR) (complete + partial response) of the combination of Pralatrexate and romidepsin in patients with relapsed/refractory T-Cell Lymphoma.;   Phase II: Maximum number of cycles received;   Phase I: Number of dose delays at the MTD;   Phase I: Overall response rate (ORR) of the study population.;   Phase II: Duration of response (DOR) of the combination in patients with T-Cell Lymphoma;   Phase II: Overall survival (OS) of patients with T-Cell Lymphoma on study;   Phase II: Progression free survival (PFS) of the combination in patients with T-Cell Lymphoma;   Phase I: Number of dose reductions at the MTD.;   Phase I: Progression free survival (PFS) of the study population.;   Phase I: Duration of response (DOR) of the study population.
6 Recruiting Phase I Bortezomib (VELCADE) in Combo With Pralatrexate in Relapsed/Refractory MM
Condition: Multiple Myeloma
Interventions: Drug: velcade;   Drug: Pralatrexate
Outcome Measures: The maximum tolerated dose (MTD) for the combination of Pralatrexate with VELCADE in previously treated adult patients with multiple myeloma.;   Clinical evidence of anti-tumor activity based on response rates;   Time to progression (TTP);   Duration of Response Outcome;   Progression free survival (PFS);   Overall survival (OS)
7 Recruiting Phase II of Carbo/Pralatrexate in Rec. Platinum-Sensitive Ovarian, Fallopian or Primary Peritoneal Cancer
Conditions: Ovarian Cancer;   Fallopian Tube Cancer;   Peritoneal Cancer
Interventions: Drug: carboplatin;   Drug: Pralatrexate
Outcome Measures: Maximum Tolerated Dose;   Response Rate;   Progression-free and Overall Survival;   Toxicities;   Pharmacokinetics
8 Unknown  Pralatrexate and Fluorouracil in Treating Patients With Recurrent Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Interventions: Drug: Pralatrexate;   Drug: fluorouracil;   Other: laboratory biomarker analysis;   Genetic: DNA analysis;   Other: high performance liquid chromatography;   Genetic: polymerase chain reaction;   Genetic: nucleic acid sequencing;   Other: pharmacological study;   Other: pharmacogenomic studies;   Genetic: polymorphism analysis
Outcome Measures: Recommended dose of PDX given in combination with a fixed dose of 5-FU administered as a 48-hour infusion given every other week;   Clinical response to therapy in subjects with measurable disease and time to disease progression in all subjects;   Toxicity profile of the combination of PDX and 5-FU;   Pharmacokinetics of PDX and 5-FU and correlate with clinical toxicity;   Polymorphisms in methylenetetrahydrofolate reductase and thymidylate synthase and correlate with clinical toxicity
9 Recruiting Phase I/II Clinical Study of Pralatrexate in Japanese Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
Condition: Peripheral T-cell Lymphoma
Interventions: Drug: Pralatrexate injection;   Dietary Supplement: Vitamin B12;   Dietary Supplement: Folic Acid
Outcome Measure: Objective response rate (ORR) per independent central review committee
10 Recruiting Alisertib (MLN8237) or Investigator's Choice in Patients With Relapsed/Refractory Peripheral T-Cell Lymphoma
Conditions: Relapsed Peripheral T-Cell Lymphoma;   Refractory Peripheral T-Cell Lymphoma
Interventions: Drug: Alisertib;   Drug: Pralatrexate;   Drug: Gemcitabine;   Drug: Romidepsin
Outcome Measures: Number of patients with overall response;   Number of patients with PFS;   Number of patients with complete response + complete response unconfirmed;   Number of patients with overall survival;   Time to disease progression, duration of response, and time to response;   Number of adverse events, serious adverse events, assessments of clinical laboratory values and clinically important abnormalities, and vital sign measurements;   Time to subsequent antineoplastic therapy;   Plasma concentration-time data to contribute to future population pharmacokinetics (PK) analysis;   Changes in reported symptoms and Quality of Life (QOL) assessment per Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) for functioning and symptoms
11 Recruiting KW 0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)
Condition: Adult T-cell Leukemia-Lymphoma
Interventions: Biological: KW-0761;   Drug: investigator's choice (Pralatrexate; gemcitabine/oxaliplatin; dexamethasone/cisplatin/cytarabine))
Outcome Measure: Overall Response Rate

These studies may lead to new treatments and are adding insight into Pralatrexate etiology and treatment.

A major focus of Pralatrexate research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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