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NCT ID: NCT03025360 Approved for marketing - Clinical trials for Tumors Harboring NTRK Fusion

Expanded Access to Provide Larotrectinib for the Treatment of Cancers With a NTRK Gene Fusion

Start date: n/a
Phase:
Study type: Expanded Access

Larotrectinib expanded access is for patients with cancer with a NTRK1, NTRK2, or NTRK3 gene fusion, who are ineligible for an ongoing larotrectinib clinical trial or have other considerations that prevent access to larotrectinib through an existing clinical trial. Gene fusion occurs when a gene is made by joining parts of two different genes. NTRK gene fusion can lead to the development of solid tumors in a variety of tissue types. The study drug larotrectinib blocks the action of the NTRK gene fusion. Expanded access is intended to treat individual patients with different types of cancers with a NTRK gene fusion who are unresponsive to current standard treatment for their condition and also are unable to participate in ongoing clinical trials.

NCT ID: NCT03025867 Approved for marketing - Clinical trials for Recurrent Ovarian Cancer

Expanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancer

Start date: n/a
Phase: N/A
Study type: Expanded Access

This is an expanded access program (EAP) for eligible patients with Recurrent Ovarian Cancer. This program is designed to provide access to niraparib prior to approval by the US Food and Drug Administration (FDA). To be eligible, patients with Recurrent Ovarian Cancer following a partial (PR) or complete response (CR) to their most recent platinum-based chemotherapy and must have experienced a PR or CR after the penultimate (next to last) platinum-based chemotherapy for at least 6 months without disease progression after this chemotherapy.

NCT ID: NCT03070093 Approved for marketing - Clinical trials for Acute Myeloid Leukemia (AML)

Expanded Access Study of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)

Start date: n/a
Phase:
Study type: Expanded Access

The purpose of this study is to provide expanded access to ASP2215 for subjects with FLT3-mutated relapsed or refractory AML or FLT3-mutated AML in composite complete remission (CRc) (complete remission [CR], complete remission with incomplete hematologic recovery [CRi], complete remission with incomplete platelet recovery [CRp]) with MRD without access to comparable or alternative therapy.

NCT ID: NCT03072667 Approved for marketing - Liver Diseases Clinical Trials

Omegaven for Compassionate Use in the Treatment of Parenteral Nutrition-Associated Liver Disease

Start date: n/a
Phase:
Study type: Expanded Access

This is a compassionate use protocol of an investigational new drug (IND). The overall purpose of the treatment is to offer alternative treatment to children who developed parenteral nutrition-associated liver disease (PNALD) and have not responded positively to currently available medical therapies. PNALD develops in newborns dependent on parenteral nutrition (PN) and are unable to tolerate adequate enteral feedings to support fluid and nutritional fluids; although PN is necessary and life sustaining, it can result in severe liver disease.

NCT ID: NCT03079687 Approved for marketing - Ovarian Cancer Clinical Trials

Expanded Access Program for Olaparib Tablets as Maintenance Therapy in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer.

Start date: n/a
Phase: N/A
Study type: Expanded Access

This is an open-label, single-arm, international, multicenter Multiple Patient Expanded Access Program (MPEAP). The program is designed to provide treatment access to olaparib tablets for patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer without other treatment options or eligible for an olaparib clinical trials.

NCT ID: NCT03089658 Approved for marketing - Clinical trials for Metastatic Merkel Cell Carcinoma

Expanded Access to Avelumab for Treatment of Metastatic Merkel Cell Carcinoma (mMCC)

Start date: n/a
Phase:
Study type: Expanded Access

Expanded access to Avelumab solution for infusion will be made available for adult patients with mMCC whose disease has progressed after receiving at least one prior chemotherapy.

NCT ID: NCT03123965 Approved for marketing - Clinical trials for Hepatitis C Virus Infection

Expanded Access to Glecaprevir/ Pibrentasvir

Start date: n/a
Phase:
Study type: Expanded Access

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to glecaprevir/ pibrentasvir prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

NCT ID: NCT03126643 Approved for marketing - Pediatric Cancer Clinical Trials

Expanded Access to Nivolumab (Opdivo)

Start date: n/a
Phase:
Study type: Expanded Access

At BMS, we work with physicians/investigators to make investigational products available to patients with life-threatening diseases that have exhausted other treatment options and where there is a reasonable expectation of benefit over risk. When contacted by a treating physician, BMS will consider requests for providing early patient access to Nivolumab in pediatric patients exhibiting a high mutational load.

NCT ID: NCT03133988 Approved for marketing - Clinical trials for HER2-positive Breast Cancer

Margetuximab Expanded Access Program

Start date: n/a
Phase:
Study type: Expanded Access

The purpose of the Expanded Access program is to provide margetuximab to patients with pretreated HER2+ breast cancer for whom potential benefit justifies potential treatment risks.

NCT ID: NCT03147742 Approved for marketing - Clinical trials for Graft-versus-host Disease (GVHD)

An Expanded Access Program of Ruxolitinib for the Treatment of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant

Start date: n/a
Phase:
Study type: Expanded Access

To provide ruxolitinib through an expanded access program for the treatment of graft-versus-host disease (GVHD) in United States to patients who are ineligible or unable to participate in any actively enrolling Incyte-sponsored clinical studies for ruxolitinib in the treatment of GVHD.