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An Expanded Access Program for AM0010 (Pegilodecakin)

ABSTRACT: This is an Expanded Access Program (EAP) available to patients who have advanced cancers, who have failed or progressed on standard of care systemic therapy and do not qualify for ongoing clinical trials.

DISEASE(S): Carcinoma,Melanoma,Breast Cancer,Pancreatic Carcinoma,Colorectal Carcinoma,Ovarian Cancer,Carcinoma, Renal Cell,Colorectal Neoplasms,Prostate Cancer,Carcinoma, Non-small-cell Lung,Renal Cell Carcinoma,Pancreatic Neoplasms,Non-small Cell Lung Carcinoma,Solid Tumors

PROVIDER: 2275175 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Individual Patient Expanded Access to CA102N

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Expanded Access of Onvansertib With FOLFIRI and Bevacizumab for the Second-Line Treatment of Participants With KRAS-Mutated Metastatic Colorectal Cancer

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Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies

Project description:The primary objective of this protocol is to provide expanded access to tabelecleucel to participants with Epstein-Barr virus-associated diseases and malignancies for whom there are no other appropriate therapeutic options, and who are not eligible to enroll in clinical studies designed to support the development and registration of tabelecleucel.

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Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies

Project description:The objective of this expanded access program is to provide ulixertinib (BVD-523) for compassionate 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 have incomplete response to or have exhausted available therapies. Ulixertinib is available for treatment as monotherapy or in combination with other clinically tolerable agent(s), conditionally approved by the drug manufacturer.

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Efficacy and Safety Results of the Afatinib Expanded Access Program.

Project description:IntroductionAfatinib is an oral, irreversible ErbB family blocker approved for first-line treatment of metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). The expanded access program (EAP) allowed early access to afatinib and provided additional data on its safety, tolerability, and efficacy.MethodsThe afatinib EAP was an open-label, multicenter, single-arm program in the United States that treated and followed patients with locally advanced or metastatic NSCLC harboring EGFR mutations. Afatinib 40 mg was administered orally once daily until discontinuation due to disease progression, adverse events (AEs), or transition to commercially available drug.ResultsThree hundred twenty-two patients received ≥1 dose of afatinib. Most patients had received prior therapies. Drug-related AEs occurred in 89.4% of patients, including 7.8% with serious AEs. The most common afatinib-related AEs (all grades) were diarrhea (77.0%) and rash (36.0%). Dose reductions occurred in 31.1% of patients. Discontinuation rates due to diarrhea (1.6%) or rash/acne (0.3%) were low. Efficacy data were collected and analyzed when available, with 17.1% and 69.9% of patients achieving objective response and disease control, respectively, in this highly pretreated population.ConclusionsNo additional or unexpected safety concerns were revealed, and afatinib demonstrated antitumor activity in a heavily pretreated NSCLC patient population in a routine clinical setting.Trial registrationClinicalTrials.gov Identifier: NCT01649284.FundingBoehringer Ingelheim Pharmaceuticals, Inc.

| S-EPMC5488108 | biostudies-literature

Early Access Program Providing HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor

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Whole genome transcriptomics of pre-access veins and hemodialysis arteriovenous fistula (AVF) samples from two-stage AVF patients with different maturation outcomes (matured vs failed)

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2023-04-19 | GSE220796 | GEO

Canadian cohort expanded-access program of nivolumab plus ipilimumab in advanced melanoma.

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| S-EPMC7467793 | biostudies-literature

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2020-01-28 | GSE119296 | GEO

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