Pharmacyclics LLC.
An Open Label Treatment Use Protocol for Ibrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
Conditions: Relapsed or Refractory Mantle Cell Lymphoma
The purpose of this study is to provide patients who have relapsed or refractory MantleCell Lymphoma (MCL) with early access to an investigational medication called ibrutinib(PCI-32765) and to collect safety information about the drug.
Exelixis
Expanded Access of Cabozantinib in Medullary Thyroid Cancer
Conditions: Medullary Thyroid Cancer
The objective of this study is to provide access to cabozantinib for eligible subjectswith medullary thyroid cancer (MTC) pending approval of Exelixis' New Drug Application(NDA) by the FDA and commercial availability of cabozantinib.
Boehringer Ingelheim
Afatinib Expanded Access Program
Conditions: Carcinoma, Non-Small-Cell Lung
This is an open-label, multi-center, single-arm trial, designed to provide early accessto afatinib and to provide additional information on the safety and efficacy of afatinibin advanced NSCLC patients who harbor an EGFR mutation.
Advanced Accelerator Applications
EAP 177Lu-DOTA0-Tyr3-Octreotate for Inoperable, SSR+, NETs, Progressive Under SSA Tx
Conditions: Neuroendocrine Tumors
Advanced Accelerator Applications is currently pursuing marketing approval for177Lu-DOTA0-Tyr3-Octreotate (Lutathera). This expanded access therapeutic protocol aimsto allow patients suffering from inoperable, somatostatin receptor positive,neuroendocrine tumors, progressive under somatostatin analogue therapy to access theinvestigational product, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera), prior to its commercialavailability.
Novartis Pharmaceuticals
An Open-label, Multi-center, Expanded Treatment Protocol of Pasireotide LAR in Patients With Acromegaly
Conditions: Acromegaly
The present study is planned as an expanded treatment protocol to provide acromegalicpatients for whom medical therapy is appropriate access to pasireotide LAR whileregulatory approval for pasireotide is sought.
Novartis
EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer
Conditions: Neoplasms, Breast
This study will provide pre-approval drug access to lapatinib, in combination withcapecitabine, to patients whose breast cancer had progressed on other therapies
Ellodi Pharmaceuticals, LP
Expanded Access Protocol for Patients With Eosinophilic Esophagitis
Conditions: Eosinophilic Esophagitis
This expanded access program is an open-label, single-arm design where consentingpatients may participate up until APT-1011 is commercially available in the relevantregions or the protocol is terminated by the Sponsor.
Boehringer Ingelheim
Tipranavir in Patients With Progressive, Systemic HIV-1 Disease Who Have Failed or Are Intolerant to Currently Approved Treatments for HIV Infection
Conditions: HIV Infections
To provide early access to tipranavir and evaluate the safety and tolerance of tipranavircombined with low dose of ritonavir in patients with progressive, HIV-1 disease who havefailed or are intolerant to currently approved treatments for HIV infection, who areunable to participate in another tipranavir controlled clinical trial and have an urgentneed for anti-HIV treatment.
Eli Lilly and Company
ALIMTA (Pemetrexed) Alone or in Combination With Cisplatin for Patients With Malignant Mesothelioma.
Conditions: Mesothelioma
This study is to evaluate the effects (good and bad) of ALIMTA and Cisplatin or ALIMTAalone on you and your malignant pleural mesothelioma as well as make ALIMTA available topatients who qualify for treatment.
Cancer Commons
Expanded Access to Ulixertinib (BVD-523) in Patients with Advanced MAPK Pathway-Altered Malignancies
Conditions: Pancreatic Cancer, Small Bowel Cancer, Colorectal Cancer, Melanoma, Non Small Cell Lung Cancer, Thyroid Cancer, Bladder Cancer, Head and Neck Cancer, Gastric Cancer, Esophageal Cancer, Cholangiocarcinoma, Ovarian Cancer, HepatoCellular Carcinoma, Glioblastoma, MAPK Gene Mutation, KRAS Activating Mutation, BRAF Gene Mutation, NRAS Gene Mutation, HRAS Gene Mutation, MEK Mutation, ERK Mutation
The objective of this expanded access program is to provide ulixertinib (BVD-523) forcompassionate use in advanced cancer patients with MAPK pathway-altered solid tumor(s),including but not limited to KRAS, NRAS, HRAS, BRAF, MEK, and ERK mutations who haveincomplete response to or have exhausted available therapies.Ulixertinib is available for treatment as monotherapy or in combination with otherclinically tolerable agent(s), conditionally approved by the drug manufacturer.