12-Month Follow-up From Phase 2 Trial of Liposomal Amikacin for Inhalation (LAI) in Patients With Nontuberculous Mycobacterial (NTM) Lung Infection

Pneumologie ◽  
2016 ◽  
Vol 70 (10) ◽  
Author(s):  
K Olivier ◽  
D Griffith ◽  
K Winthrop ◽  
B Brown-Elliott ◽  
G Eagle ◽  
...  
Keyword(s):  
Lung Infection ◽  
Phase 2 ◽  
Phase 2 Trial

scholarly journals Lenalidomide and prednisone for myelofibrosis: Eastern Cooperative Oncology Group (ECOG) phase 2 trial E4903

Blood ◽  
2010 ◽  
Vol 116 (22) ◽  
pp. 4436-4438 ◽  
Author(s):  
Ruben A. Mesa ◽  
Xiaopan Yao ◽  
Larry D. Cripe ◽  
Chin Yang Li ◽  
Mark Litzow ◽  
...  
Keyword(s):  
Eastern Cooperative Oncology Group ◽  
Hematologic Toxicity ◽  
Cooperative Group ◽  
Phase 2 ◽  
Phase 2 Trial ◽  
Nonhematologic Toxicity ◽  
Grade 3 ◽  
Bone Marrow Analysis ◽  
Dose Prednisone

A multicenter Eastern Cooperative Group (ECOG) phase 2 trial assessed whether adding prednisone to lenalidomide would improve previously reported responses in persons with myelofibrosis (MF). Forty-eight subjects with anemia (42 evaluable) received lenalidomide, 10 mg/d, with a 3-month low-dose prednisone taper. Ten subjects received 3 months, and 25 received 6 months of therapy. Myelosuppression was the main toxicity with 88% with ≥ grade 3 hematologic toxicity and 45% ≥ grade 3 nonhematologic toxicity. There were responses in 10 subjects (23%) using the International Working Group for Myelofibrosis Research and Treatment (IWG-MRT)–defined clinical improvement of anemia in 8 (19%) and/or decreased spleen size in 4 (10%). Serial bone marrow analysis showed no resolution of disease-related fibrosis or angiogenesis. With a median follow-up of 2.3 years, 23 subjects are alive. Lenali-domide and prednisone for myelofibro-sis evaluated through a multicentered-cooperative group mechanism is only modestly active and myelosuppre-sive. This study was registered at http://clinicaltrials.gov as NCT00227591.

Atezolizumab + obinutuzumab + venetoclax in patients with relapsed or refractory indolent non-Hodgkin’s lymphoma (R/R iNHL): Primary analysis of a phase 2 trial from LYSA.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 7544-7544
Author(s):  
Charles Herbaux ◽  
Herve Ghesquieres ◽  
Reda Bouabdallah ◽  
Stephanie Guidez ◽  
Emmanuel Gyan ◽  
...  
Keyword(s):  
Tumor Lysis Syndrome ◽  
Safety Data ◽  
Induction Treatment ◽  
Phase 2 ◽  
Primary Analysis ◽  
Phase 2 Trial ◽  
Ann Arbor ◽  
Baseline Characteristics ◽  
Grade 3

7544 Background: R/R iNHL treatment remains challenging. Atezolizumab (ATE) and obinutuzumab (OBI) are monoclonal antibodies acting respectively to inhibit T-lymphocyte exhaustion or by inducing lymphoma cells cytotoxicity, whereas venetoclax (VEN) is a small molecule inhibiting BCL-2. Combining tumor-targeted therapies with agents that enhance anti-tumor immunity represents an attractive treatment paradigm. This LYSA sponsored multicenter phase 2 trial (NCT03276468) evaluated ATE, OBI and VEN combination in R/R B-cell lymphomas. Herein, we present primary efficacy and safety data from the iNHL cohort including Follicular Lymphoma (FL) and Marginal Zone Lymphomas (MZL). Methods: Patients ≥18 years with biopsy-confirmed R/R FL and MZL who failed at least one line of therapy were eligible. OBI was given IV at 1 g on day (D) 1, 8 and 15 of cycle (C) 1 and on D1 from C2 to C8 every 3 weeks. ATE was given IV, 1.2 g every 3 weeks, started at D2 of C1, then administered at D2 of each cycle for 24 cycles. VEN was given orally at 800 mg/D at full dose, starting on D8C1 for 24 cycles. The primary endpoint was the Overall Response Rate (ORR) evaluated by Lugano criteria at the end of induction (EOI) after 8 cycles of ATE, OBI and VEN (M6) or at premature treatment discontinuation. Results: At the time of the primary analysis (08 Jan 2021), 78 patients were enrolled. FL cohort (n = 58): the median follow-up was 14.5 months. Main baseline characteristics were: Ann Arbor Stage III/IV, 85.7%; FLIPI HR, 47.3%; > 2 prior lines of therapy, 32.1%; and exposed to ASCT, 30.4%. The ORR on PET scan at EOI was measured at 53.6% [41.8%-65.1%], including 30.4% of CMR. 37 patients (63%) received the full induction treatment. MZL cohort (n = 20; 13 nMZL, 5 eMZL, 2 sMZL): the median follow-up was 11.9 months. Main baseline characteristics were: Ann Arbor Stage IV, 100%; bone marrow infiltration, 38.9%; ≥ 2 extra-nodal sites, 50%; and > 2 prior lines of therapy, 22.2%. The ORR on CT scan at EOI was measured at 66.76% [44.6%-84.4%], including 16.7% of CR and 50.0% PR. 11 patients (55%) received the full induction treatment. At time of the present analysis, responses in the 2 cohorts seem durable with only 21,4% of responders who have reported relapse/progression. Out of the 78 pts, a total of 55 (70.5%) pts experienced grade 3–4 adverse event (AE) and 1 patient experienced an AE that led to discontinuation of any drug. Main AE of grade 3 or more were hematologic cytopenias, with only one febrile neutropenia (1.3%). Three pts experienced immune-related AE (1 grade 2 myositis and 2 grade 3 colitis), no tumor lysis syndrome was observed. Conclusions: ATE, OBI and VEN triplet appears to be well tolerated, with no unexpected toxicity brought by the combination. The ORR at EOI seems to be comparable to other innovative regiments in this setting, with durable responses to date. Clinical trial information: NCT03276468.

scholarly journals Microwave Versus Radiofrequency Ablation for the Treatment of Liver Malignancies: A Randomized Controlled Phase 2 Trial

2021 ◽  
Author(s):  
Aleksandar Radosevic ◽  
Rita Quesada ◽  
Clara Serlavos ◽  
Juan Sánchez ◽  
Ander Zugazaga ◽  
...  
Keyword(s):  
Radiofrequency Ablation ◽  
Liver Tumors ◽  
Statistical Significance ◽  
Phase 2 ◽  
Liver Malignancies ◽  
Phase 2 Trial ◽  
Primary Endpoints ◽  
Phase 2 Clinical Trial ◽  
Ablative Techniques

Abstract Purpose: Microwave (MWA) and radiofrequency ablation (RFA) are main ablative techniques for hepatocellular carcinoma (HCC) and colorectal liver metastasis (MT). This randomized phase 2 clinical trial compares the effectiveness of MWA and RFA in medium-sized liver tumors.Methods: HCC and MT patients with 1.5 to 4 cm tumors suitable for ablation were randomized into MWA or RFA Groups. The primary endpoints were primary technical success (TS) and local tumor progression (LTP) rate after a 2-year follow-up. Secondary endpoints were safety and overall survival. Results: Between June 2015 and April 2020, 82 patients were randomly assigned (41 patients per group). For the per-protocol analysis, three patients were excluded. Median follow-up was 27 months (MWA group) and 23 months (RFA Group). The TS was achieved in 98% (46/47) and 90 % (45/50) (p=0.108), and LTP was observed in 21% (10/47) vs. 12% (6/50) (OR 1.9 [95% CI 0.66-5.3], p=0.238) of tumors in the MWA and RFA Group, respectively. Major complications were found in 5 cases (11%) in the MWA Group vs. 2 cases (4%) in RFA, without statistical significance. MWA created larger ablation zones than RFA (p=0.036).Conclusion: MWA and RFA show similar effectiveness and safety in medium-sized liver tumors (1.5-4 cm).

scholarly journals Apatinib plus camrelizumab (anti-PD1 therapy, SHR-1210) for advanced osteosarcoma (APFAO) progressing after chemotherapy: a single-arm, open-label, phase 2 trial

2020 ◽  
Vol 8 (1) ◽  
pp. e000798
Author(s):  
Lu Xie ◽  
Jie Xu ◽  
Xin Sun ◽  
Wei Guo ◽  
Jin Gu ◽  
...  
Keyword(s):  
Pulmonary Metastases ◽  
Single Agent ◽  
Objective Response ◽  
Progression Free Survival ◽  
Phase 2 ◽  
Open Label ◽  
Phase 2 Trial ◽  
Open Label Phase ◽  
High Grade Osteosarcoma

BackgroundResults of our previous study showed high objective response but short-term activity of apatinib in advanced osteosarcoma. We aimed to investigate the activity of apatinib in combination with camrelizumab in patients with inoperable high-grade osteosarcoma progressing after chemotherapy.MethodsThis open-label, phase 2 trial was conducted at Peking University People’s Hospital. We enrolled patients with advanced osteosarcoma progressed after chemotherapy. Patients received 500 mg apatinib orally once daily plus 200 mg camrelizumab by intravenous infusion every 2 weeks until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS) and clinical benefit rate at 6 months, which were based on RECIST V.1.1.Results43 patients were enrolled between January 25 and September 4, 2018. With median follow-up time of 48.3 (Q1, Q3, 30.6, 66.6) weeks, 13 (30.23%, 95% CI 17.2%, 40.1%) of 43 patients were progression free at 6 months and the 6-month PFS rate was 50.9% (95% CI 34.6%, 65.0%). Until final follow-up, the objective response rate was 20.9% (9/43) and two patients with durable disease control were observed. Patients with programmed cell death 1 ligand-1 (PD-L1) tumor proportion score ≥5% and pulmonary metastases tended to have a longer PFS in comparison to the others (p=0.004 and 0.017, respectively). Toxic effects led to dose reductions, or interruptions, or both in 24 (55.8%) of 43 patients and permanent discontinuation in 4 (9.3%) patients. There were no treatment-related deaths.ConclusionsAlthough the combination of apatinib and camrelizumab seemed to prolong PFS in comparison to single agent apatinib in treating advanced osteosarcoma, it did not reach the prespecified target of 6-month PFS of 60% or greater. Overexpression of PD-L1 and the presence of pulmonary metastases only were associated with longer PFS.Trial registration numberNCT03359018.

scholarly journals Extended follow-up of a phase 2 trial of bortezomib alone and in combination with dexamethasone for the frontline treatment of multiple myeloma

2009 ◽  
Vol 146 (6) ◽  
pp. 619-626 ◽  
Author(s):  
Sundar Jagannath ◽  
Brian G. M. Durie ◽  
Jeffrey Lee Wolf ◽  
Elber S. Camacho ◽  
David Irwin ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Phase 2 ◽  
Phase 2 Trial ◽  
Frontline Treatment

Updated survival of patients (pts) with previously treated BRAF V600E–mutant advanced non-small cell lung cancer (NSCLC) who received dabrafenib (D) or D + trametinib (T) in the phase II BRF113928 study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 9075-9075 ◽  
Author(s):  
David Planchard ◽  
Benjamin Besse ◽  
Tae Min Kim ◽  
Elisabeth A. Quoix ◽  
Pierre Jean Souquet ◽  
...  
Keyword(s):  
Progression Free Survival ◽  
Braf V600e ◽  
Phase 2 ◽  
Primary Analysis ◽  
Durable Response ◽  
Phase 2 Trial ◽  
Duration Of Response ◽  
Independent Review ◽  
Previously Treated

9075 Background: BRAF V600E mutations occur in 1% to 2% of lung adenocarcinomas and act as oncogenic drivers. Initial cohorts of the BRF113928 (NCT01336634) trial evaluated efficacy and safety of D monotherapy (cohort A; n = 78) or D + T (cohort B; n = 57) in pts with previously treated BRAFV600E–mutant metastatic NSCLC. At primary analysis, overall response rates (ORRs) were 33.3% and 63.2% in pts who received D or D + T, respectively. Furthermore, durable response (median duration of response [DOR], 9.0 mo) was observed in D + T pts. Here, we present an updated survival analysis based on additional follow-up. Methods: In this phase 2 trial, 2 cohorts (A and B) of pts with previously treated metastatic BRAFV600E–mutant NSCLC were enrolled sequentially. The primary endpoint was investigator-assessed ORR. Secondary efficacy endpoints included progression-free survival (PFS), DOR, and overall survival (OS). D and T were dosed orally at the established phase 2 dose of D 150 mg twice daily and T 2 mg once daily. Results: This updated analysis had a median follow-up of 16.2 mo, which represented an additional 10 mo of follow-up. Median OS was 12.7 mo (95% CI, 7.3-16.3) with 57 deaths reported for pts treated with D monotherapy and 18.2 mo (95% CI, 14.3-not estimable [NE]) with 33 deaths reported for pts treated with D + T. Detailed efficacy results are presented in the table. Investigator-assessed ORR, DOR, and PFS were supported by independent review committee assessments. No new safety signals were observed for D + T. Conclusions: This update of the BRF113928 study confirms that durable responses and encouraging survival were achieved with combination D + T in pts with BRAFV600E–mutant NSCLC. Clinical trial information: NCT01336634. [Table: see text]

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