Solid Tumor/Phase I Clinical Trials

Showing 1-30 of 38 items
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  • A Study of Oral Rucaparib in Patients With gBRCA Mutation Breast or Ovarian Cancer, or Other Solid Tumor
  • The purpose of the first part of the study is to evaluate the safety of different doses of oral rucaparib given daily to patients with solid tumors. The purpose of the second part of the study is to determine the safety and clinical activity of oral rucaparib given daily to patients with locally advanced or metastatic breast cancer associated with a germline breast cancer (gBRCA) mutation and to patients with platinum-sensitive relapsed ovarian cancer associated with a gBRCA mutation who have received at least two, but no more than three, prior regimens (all platinum based).
  • Diagnoses: Solid Tumor/Phase I, Breast: Metastatic
  • Status: Recruiting
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  • Safety Study of MGA271 in Refractory Cancer
  • The purpose of this study is to evaluate the safety of MGA271 when given by intravenous (IV) infusion to patients with refractory cancer. The study will also evaluate how long MGA271 stays in the blood and how long it takes for it to leave the body, what is the highest dose that can safely be given, and whether it may have an effect on tumors.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • A Two Part, Multicenter, Open-label Study of TEN-010 Given Subcutaneously
  • TEN-010 is a small molecule, bromodomain and extra-terminal domain (BET) bromodomain inhibitor. This study is designed to characterize the safety, tolerability, pharmacokinetics and anti-tumor activity of TEN-010 in patients who are refractory or intolerant to standard/approved therapies. This first-in-human study of TEN-010 will be conducted in two parts: dose escalation and dose expansion. For dose escalation (Part A), a standard "3+3" design will be used in which successive cohorts of three or more patients with advanced solid tumor malignancies will be treated at escalating doses until a maximum tolerated dose (MTD) is identified. For the dose expansion part of the study (Part B), a subset of patients with advanced solid malignancies will be treated with TEN-010 at the MTD (or the highest dose tested if the MTD is not defined) to further characterize safety and biological effect. In addition, up to 10 patients with nuclear protein in testis (NUT) midline carcinoma (NMC) will be permitted to enroll in a substudy of the protocol.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • Veliparib and Dinaciclib With or Without Carboplatin in Treating Patients With Advanced Solid Tumors
  • This phase I trial studies the side effects and the best dose of veliparib and dinaciclib given together with or without carboplatin and to see how well they work in treating patients with advanced solid tumors. Veliparib and dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving veliparib and dinaciclib with or without carboplatin may kill more tumor cells
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • MLN0128 and Bevacizumab in Treating Patients With Recurrent Glioblastoma or Advanced Solid Tumors
  • This phase I trial studies the side effects and best dose of MLN0128 when given in combination with bevacizumab in treating patients with glioblastoma, a type of brain tumor, or a solid tumor that has spread and not responded to standard treatment. MLN0128 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the progression of tumors by blocking the growth of new blood vessels necessary for tumor growth.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • Safety Study of PLX108-01 in Patients With Solid Tumors
  • PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity. The primary objective of this study is to evaluate the safety and pharmacokinetics of orally administered PLX3397 in patients with advanced, incurable, solid tumors in which these target kinases are linked to disease pathophysiology. These tumors include, but are not limited to, acute myelogenous leukemia (Flt3), gastrointestinal stromal tumor and neurofibromatosis-1 (Kit), and glioma, breast cancer, prostate cancer, multiple myeloma, Hodgkin lymphoma, and osteosarcoma (Fms/CSF-1). The secondary objective is to measure the pharmacodynamic activity of PLX3397 via plasma and urine biomarkers of Fms activity.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • A Safety, Pharmacokinetic and Pharmacodynamic Study of Kevetrin in Patients With Advanced Solid Tumors
  • In the laboratory, Kevetrin activates p53, a tumor suppressor protein that has an important role in protecting the body. p53 functions by activating proteins that repair DNA and kill cells that have genetic mutations such as in cancers. Research experiments showed that when cancer cells were treated with Kevetrin, it activated p53 which induced p21, a protein that inhibits cancer cell growth. p53 also induced PUMA (p53 up-regulated modulator of apoptosis), a protein that causes tumor cell death. Because of these activities, slowing cancer cell growth and causing cancer cell death, Kevetrin may help to treat tumors.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • AZD8186 First Time In Patient Ascending Dose Study
  • This is a phase I, open-label, multicentre study of AZD8186 administered orally in patients with advanced castrate-resistant prostate cancer (CRPC), squamous non-small cell lung cancer (sqNSCLC), triple negative breast cancer (TNBC) and known PTEN-deficient advanced solid malignancies. The study design allows an escalation of dose with intensive safety monitoring to ensure the safety of the patients. There are two parts to this study: Part A, dose escalation, and Part B, expansion cohort(s) at the intended therapeutic dose(s).
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • A Study Evaluating the Safety of Escalating Doses of DLYE5953A in Patients With Refractory Solid Tumors
  • This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and PK of escalating doses of DLYE5953A administered to patients with incurable, locally advanced, or metastatic solid malignancy that has progressed on standard therapy. The Phase I study consists of two stages: Stage 1 dose-escalation and Stage 2 expansion in selected patients. In Stage 1, a 3 + 3 dose-escalation design will be used to examine the safety, tolerability, and PK of increasing doses of DLYE5953A. In Stage 2, patients will be enrolled to further characterize the safety, tolerability, and PK of the proposed dose and schedule for future studies.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • Study of MK-3475 in Participants With Advanced Solid Tumors (MK-3475-028/KEYNOTE-28)
  • This study will assess the efficacy and safety of MK-3475 administered to participants with advanced biomarker-positive solid tumors that have not responded to current therapy, for which current therapy is not appropriate, or for which no current therapy exists. The hypothesis is that administration of MK-3475 to participants with some types of solid tumors will result in a clinically meaningful response rate.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents
  • This study will evaluate PF-05212384 (PI3K/mTOR inhibitor) in combination with either docetaxel, cisplatin or dacomitinib in select advanced solid tumors. The study will assess the safety, pharmacokinetics and pharmacodynamics of these combinations in patients with advanced cancer in order to determine the maximum tolerated dose in each combination.
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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  • A Phase I/Ib Trial for the Evaluation of SAR260301 in Monotherapy or in Combination With Vemurafenib in Patients With Various Advanced Cancer
  • Primary Objective: Part A - Monotherapy: - To determine the maximum tolerated dose (MTD) of SAR260301 administered as monotherapy and either on a once or twice daily schedule, to patients with advanced solid tumors or lymphomas. Part B - Combination: - To determine the maximum tolerated dose (MTD) of SAR260301 administered in combination with the recommended standard dosage of Vemurafenib to patients with unresectable / metastatic v-raf murine sarcoma viral oncogene homolog B1 (BRAF)-mutated melanoma. Secondary Objectives: - To characterize the overall safety and tolerability profile of SAR260301 administered as monotherapy (Part A) and in combination with Vemurafenib (Part B). - To characterize the pharmacokinetic (PK) profile of SAR260301 administered as monotherapy (Part A) and in combination with Vemurafenib (Part B) as well as Vemurafenib PK in combination with SAR260301 (Part B) - To evaluate food effect on SAR260301 PK (Part A) - To assess preliminary antitumor activity according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1 criteria). - To assess preliminary antitumor activity using volumetric computed tomography (CT) or magnetic resonance imaging(MRI) - To evaluate the pharmacodynamic (PD) effects of SAR260301 on blood and tumor. - To evaluate PK/PD relationships. - To identify the recommended phase 2 dose of SAR260301 in combination with Vemurafenib (RP2D) (Part B only) - To assess potential induction effect of SAR260301 on cytochrome P450 (CYP) isoenzyme 3A (CYP3A) (Part A)
  • Diagnoses: Solid Tumor/Phase I
  • Status: Recruiting
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Showing 1-30 of 38 items
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