A treatment cycle is 28 days. Tagraxofusp will be administered at 9 mcg/kg IV over 15 minutes (-5 or +15 minutes) daily for 3 consecutive days (or 3 doses over a period not to exceed 10 days if postponement is required to allow for toxicity resolution), followed by azacitidine administered at 75 mg/m2 SQ or IV daily on Day 4 through Day 10. Venetoclax will begin on Day 4 and continue through Day 24 (21 consecutive days). A bone marrow biopsy (BM Bx) will be performed on Day 24 (+3 days) of Cycle 1.
Subjects who do not achieve a CRm will proceed with the next cycle of Induction Phase study treatment, irrespective of hematologic laboratory values. Cycle 2+ will consist of tagraxofusp 9 mcg/kg IV over 15 minutes daily for 3 consecutive days (Day 1-3 or 3 doses over a period not to exceed 10 days if postponement is required to allow for toxicity resolution), azacitidine 75 mg/m2 SQ or IV on Day 1 through Day 7 or Days 1-7 or 1-5, 8-9 and venetoclax 400 mg daily Day 1 through Day 21.
A bone marrow biopsy (BM Bx) will be performed on Day 21 (+3 days) of Cycle 2. If a CRm is obtained or maintained, the subject will move to or remain on the Continuation Phase. Subjects who do not achieve a marrow CR (CRm) after Cycle 2 will proceed with the next cycle of Induction Phase study treatment as described above, irrespective of hematologic laboratory values. If a CRm is obtained after Cycle 3 or 4, the subject will move to the Continuation Phase .
If a CRm is not obtained after Cycle 4, study treatment will be discontinued and the subject will move to follow up. If per the investigator, the subject is receiving clinical benefit, study treatment may continue until toxicity or completion of 12 total cycles. A BM Bx will be performed at least every 3 cycles for these subjects.

Start Date01 May 2024

Sponsor / Collaborator

Hoosier Oncology Group, Inc.

[+2]

NCT05502315

/ RecruitingPhase 2

A Phase 2 Study of Cabozantinib and Nivolumab in Metastatic Castration Resistant Prostate Cancer

This is a multicenter, single-arm, two-stage open-label phase 2 study of the combination of cabozantinib + nivolumab in subjects with advanced castration-resistant prostate cancer (CRPC).

Start Date02 Feb 2023

Sponsor / Collaborator

Hoosier Oncology Group, Inc.

[+2]

NCT03241186

/ Active, not recruitingPhase 2

Single Arm Phase II Study of Ipilimumab and Nivolumab as Adjuvant Therapy for Resected Mucosal Melanoma (SALVO Study). HCRN: MEL16-252

This is a single arm phase II clinical trial of Ipilimumab and Nivolumab in patients with resected mucosal melanoma. Ipilimumab (1 mg/kg) and Nivolumab (3 mg/kg) will be administered Day 1 of a 21-day cycle in Cycles 1-4 and then nivolumab 480 mg will be administered Day 1 of a 28-day cycle for Cycles 5-15 (maximum of 15) or until disease recurrence or intolerance before completion of 15 cycles.

Start Date12 Sep 2017

Sponsor / Collaborator

Hoosier Oncology Group, Inc.

[+2]

100 Clinical Results associated with Hoosier Oncology Group, Inc.

0 Patents (Medical) associated with Hoosier Oncology Group, Inc.

Literatures (Medical) associated with Hoosier Oncology Group, Inc.

01 Feb 2014·Clinical genitourinary cancerQ3 · MEDICINE

Failure to Suppress Markers of Bone Turnover on First-Line Hormone Therapy for Metastatic Prostate Cancer Is Associated With Shorter Time to Skeletal-Related Event

Q3 · MEDICINE

Article

Author: Sharma, Jaya ; Sweeney, Christopher J ; Yiannoutsos, Constantin T ; Hahn, Noah M ; Kirkpatrick, Kristina

BACKGROUND:

Elevated markers of bone turnover are prognostic for shorter survival in castration-resistant prostate cancer. We aimed to determine the prognostic value of bone turnover markers in metastatic hormone-sensitive prostate cancer.

PATIENTS AND METHODS:

Markers of bone turnover (urine deoxypyridinoline [DPD] and N-telopeptide, serum bone alkaline phosphatase (AP), and osteocalcin [OC]) from baseline and after 6 months of study were assessed in men enrolled in a prospective metastatic prostate cancer trial with androgen deprivation therapy (ADT) with or without risedronate (ClinicalTrials.gov, NCT00216060).

RESULTS:

Serum samples were collected from 63 patients with bone involvement and a median follow-up of 39.7 months. A multivariate model using Cox regression-which included prostate-specific antigen (PSA) nadir, bisphosphonate treatment, and extent of metastases-showed that suppression of bone turnover markers after 6 months of therapy compared with baseline was significantly associated with longer skeletal-related event (SRE)-free survival. ADT without bisphosphonate therapy was also associated with a decline in markers of bone turnover, presumably resulting from direct anticancer activity. Elevated baseline bone turnover markers were not prognostic.

CONCLUSION:

Failure to suppress bone turnover while receiving ADT, even when otherwise responding to therapy, may identify patients with hormone-sensitive metastatic prostate cancer who are destined for a shorter time to SREs and progression.

01 May 2013·Clinical lung cancerQ2 · MEDICINE

Erlotinib and Bevacizumab in Newly Diagnosed Performance Status 2 or Elderly Patients With Nonsquamous Non–Small-Cell Lung Cancer, a Phase II Study of the Hoosier Oncology Group: LUN04-77

Q2 · MEDICINE

Article

Author: Baghdadi, Tareq Al ; Jalal, Shadia I. ; Riggs, Heather ; Bhatia, Sumeet ; Yu, Menggang ; Hanna, Nasser ; McClean, John ; Taber, David ; Johnson, Cynthia ; Harb, Wael

BACKGROUND:

Poor PS is a negative prognostic factor for survival and a risk factor for treatment-related toxicity with standard platinum-doublet chemotherapy for advanced NSCLC. A phase II study combining erlotinib and bevacizumab for treatment of recurrent NSCLC showed encouraging efficacy and acceptable toxicity.

PATIENTS AND METHODS:

This single-arm phase II study evaluated erlotinib and bevacizumab as first-line therapy for newly diagnosed nonsquamous advanced NSCLC patients with Eastern Cooperative Oncology Group PS ≥ 2 or age 70 or older. Only patients eligible for bevacizumab per label were enrolled. Patients received erlotinib 150 mg orally daily and bevacizumab 15 mg/kg intravenously on day 1 every 21 days for up to 6 cycles. The primary end point was the rate of nonprogressive disease at 4 months (alternative hypothesis > 60%).

RESULTS:

Twenty-five patients were enrolled, with median age 77 years (range, 52-90 years), 44% female, 20% never- or remote-smokers. Ninety-two percent of patients enrolled had PS of 2 per investigator assessment. The rate of nonprogressive disease at 4 months was 28%. There were no complete responses, 1 patient achieved a partial response, and 11 patients (44%) experienced stable disease as best response. Rash, fatigue, and diarrhea were the most common toxicities.

CONCLUSION:

The combination of erlotinib and bevacizumab had insufficient activity in the absence of known activating epidermal growth factor receptor gene mutations to warrant study in newly diagnosed elderly or poor PS patients with nonsquamous NSCLC.

01 Jan 2012·The oncologistQ2 · MEDICINE

Phase II Trial of Erlotinib and Docetaxel in Advanced and Refractory Hepatocellular and Biliary Cancers: Hoosier Oncology Group GI06-101

Q2 · MEDICINE

Article

Author: Coleman, Nicki ; Tong, Yan ; Picus, Joel ; Bufill, Jose A. ; Currie, Colleen ; Loehrer, Patrick J. ; Chiorean, E. Gabriela ; Johnston, Erica L. ; Ramasubbaiah, Rashmi ; Yu, Menggang

Abstract:

Background.:

Patients with advanced hepatocellular (HCC) and biliary tract carcinomas (BTC) have poor prognosis. While the EGFR pathway is overactive in HCC and BTC, single agent anti-EGFR therapies confer modest activity. Preclinical data showed synergistic antiproliferative and proapoptotic effects between anti-EGFR therapies and taxanes. We conducted a phase I study of erlotinib and docetaxel in solid tumors, and noted good tolerability and sustained complete (5 years +) and partial responses in patients with HCC and BTC. This trial evaluated the efficacy of erlotinib with docetaxel in refractory hepatobiliary cancers.

Methods.:

Eligible patients were allowed to have two prior systemic therapies. Docetaxel 30 mg/m2 i.v. was administered on days 1, 8, 15, and erlotinib 150 mg was dosed orally on days 2–7, 9–14, 16–28 of each 28-day cycle. The primary endpoint was 16 weeks progression-free survival (PFS), and secondary endpoints included response, stable disease, and overall survival. Tumor samples were analyzed for KRAS gene mutations and E-cadherin expression by immunohistochemistry (IHC). Patients with BTC and HCC were accrued and assessed in separate strata for the efficacy endpoints, but for the two-stage initial design of the study, combined PFS was considered. A Simon optimal two-stage design tested the hypothesis that the 16-week PFS is ≤ 15% (clinically inactive) versus the alternative of ≥ 30% (warranting further study).

Results.:

Twenty-five patients, 14 with HCC and 11 with BTC, were enrolled. Common toxicities were rash (76%), diarrhea (56%), and fatigue (52%), mostly grade 1 or 2. No objective responses were seen. Seven BTC (64%) and 6 HCC patients (46%) had stable disease as best response, with a median duration of 16.1 weeks (95% CI 3.7–56.3) for BTC, and 17.6 weeks (95% CI 8.1–49.8) for HCC. The 16-week PFS was 64% for BTC (95% CI 29.7–84.5), and 38% for HCC (95% CI 14.1–62.8). Median overall survival was 5.7 and 6.7 months for BTC and HCC patients, respectively. BTC patients with grade ≥ 2 rash had higher median PFS (6.2 vs 2.2 months) and OS (14.2 vs 4.2 months). HCC patients with negative/low E-cadherin expression had higher median PFS (6.7 vs 2.1 months) and OS (14.5 vs 4 months).

Conclusion.:

Erlotinib with docetaxel met the 16-week PFS ≥ 30% endpoint,but overall survival was comparable to that seen with single-agent erlotinib. With the limitation of small numbers of patients, grade ≥ 2 rash (in BTC), and negative/low E-cadherin expression (HCC) were associated with higher PFS and OS.

100 Deals associated with Hoosier Oncology Group, Inc.

100 Translational Medicine associated with Hoosier Oncology Group, Inc.

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