Advanced and Metastatic Disease

BBI 608-CanStem303c

A Phase III Study of BBI-608 in Combination With 5-Fluorouracil, Leucovorin, Irinotecan (FOLFIRI) in Adult Patients With Previously Treated Metastatic Colorectal Cancer (CRC). 

Purpose

To determine if the addition of BBI-608 will increase the survival of patients with metastatic (Stage IV) colorectal cancer.

Eligibility

This study is looking for patients who are diagnosed with advance Colorectal Cancer who have failed one chemotherapy regimen. Patient must be able and willing to swallow the study drug daily.

Learn more about study.

NRG-CC001

Memantine Hydrochloride and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance in Reducing Neurocognitive Decline in Patients With Brain Metastases

Purpose

This trial compares memantine hydrochloride and whole-brain radiotherapy with or without hippocampal avoidance in patients with cancer that has spread from the primary

Eligibility 

This study is looking for patients who have a brain metastases who have not received brain radiation.

Learn more about study.

NRG BR002

Standard of Care Therapy With or Without Stereotactic Radiosurgery and/or Surgery in Treating Patients With Limited Metastatic Breast Cancer

Purpose

This trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has spread to one or two locations in the body (limited metastatic) that are previously untreated.

Eligiblity

This study is looking for patients with confirmed metastatic breast cancer.

Learn more about this study.

NRG BR001

A Phase 1 Study of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases (BONE METS TEMP CLOSED)

Purpose

This trial studies the side effects and the best dose of stereotactic body radiation therapy in treating patients with breast cancer, non-small cell lung cancer, or prostate cancer that has spread to other parts of the body. Treatment

Eligiblity

This study is looking for patients with metastatic breast cancer or metastatic non-small cell lung cancer or metastatic adenocarcinoma of the prostate.

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RTOG 1119

Phase II Randomized Study of Whole Brain Radiotherapy in Combination With Concurrent Lapatinib in Patients With Brain Metastasis From HER2-Positive Breast Cancer: A Collaborative Study of RTOG and KROG

Purpose

This trial studies how well whole-brain radiation therapy (WBRT) with or without lapatinib works in treating patients with HER2 positive breast cancer that has spread to the brain.

Eligibility

This study is looking for patients with proven diagnosis of invasive HER2 positive breast cancer that has spread to the brain.

Learn more about this study

SCRX001-007 AbbVie/Stemcentrx 

An Intensive QT/QTc Study to Investigate the Effects of Rovalpituzumab Tesirine on Cardiac Ventricular Repolarization In Subjects with Small Cell Lung Cancer.

Purpose

To evaluate the effect of rovalpituzumab tesirine on cardiac ventricular repolarization in subjects with small cell lung cancer.

Eligibility

Histologically confirmed extensive stage small cell lung cancer.

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Incyte INCB 54828-202 

Efficacy and Safety of INCB054828 in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy

Purpose

The purpose of this study is evaluate the efficacy of INCB054828 in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocation who have failed at least 1 previous treatment.

Eligibility

Histologically or cytologically confirmed cholangiocarcinoma with radiographically measurable or evaluable disease. Disease progression after at least 1 line of prior systemic therapy. Tumor assessment for FGF/FGFR gene alteration status.

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Incyte INCB 50465-202 

A Phase 2 Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)

Purpose

The purpose of this study is to assess the safety and efficacy of INCB050465 in subjects with relapsed or refractory diffuse large B-cell lymphoma.

Eligibility

Relapsed or refractory DLBCL, which has been histologically documented, defined as having received at least 2 but no more than 5 prior treatment regimens and ineligible for high-dose chemotherapy supported by autologous stem cell transplant. Must have at least 1 measureable lesion that is ≥ 2 cm.

Learn more about this study

Merck MK-3475-022-02 

A Study of the Safety and Efficacy of Pembrolizumab (MK-3475) in Combination With Trametinib and Dabrafenib in Participants With Advanced Melanoma (MK-3475-022/KEYNOTE-022)

Purpose

This is a 5-part dose-finding and preliminary efficacy study of pembrolizumab (Pembro) + dabrafenib (D) + trametinib (T) for participants with advanced melanoma. Parts 1 and 2 are open-label to find and confirm the maximum tolerated dose (MTD)/maximum administered dose (MAD) for Pembro+D+T. The primary hypothesis (Parts 1 and 2) is that Pembro+D+T is sufficiently well-tolerated to permit clinical investigation. Part 3 is a double-blind study of Pembro+D+T versus placebo+D+T. The primary study hypothesis (Part 3 only) is that the Pembro+D+T improves progression-free survival (PFS) compared with placebo+D+T. Part 4 is nonrandomized and open-label and is designed to evaluate the safety and tolerability and identify the MTD or MAD of Pembro+T in participants who have v-raf murine sarcoma viral oncogene homolog B1 [BRAF] mutation-negative (without V600 E or K) melanoma or solid tumors [irrespective of BRAF status]. The primary hypothesis (Part 4) is that Pembro+T is sufficiently well-tolerated to permit clinical investigation. Part 5 will confirm the dose(s) identified in Part 4 in participants BRAF wild type [without V600E or K] melanoma or solid tumors [irrespective of BRAF status] and will further evaluate the safety and preliminary efficacy (Objective Response Rate [ORR]) of Pembro+T in participants who have BRAF wild type [without V600E or K] melanoma only. The primary hypotheses (Part 5) are that Pembro+T is sufficiently well-tolerated at the MTD/MAD to permit further clinical investigation and is effective in attaining objective responses based upon Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator review in participants who have melanoma without BRAF V600 E or K mutations. Parts 1 and 2 of the study will also explore the MTD/MAD for open-label Pembro+T (for BRAF mutation-negative participants) concurrently with the Pembro+D+T arm; Pembro+D (for BRAF mutation-positive participants).

Eligibility

Histologically-confirmed diagnosis of advanced (unresectable Stage III) or metastatic (Stage IV) melanoma excluding mucosal, or ocular melanoma (or a histologically or cytologically-documented locally-advanced or metastatic solid malignancy in Parts 4 and 5). At least one measurable lesion on imaging studies. BRAF mutation negative melanoma with progression after at least one prior therapy. For solid tumor, must have failed prior therapy.

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Celgene MEDI4736-DLBCL-001 

A Study of Durvalumab in Combination With R-CHOP or Lenalidomide Plus R-CHOP in Previously Untreated High-Risk Diffuse Large B-Cell Lymphoma

Purpose

This Phase 2, two-arm, open-label study is designed to evaluate the safety, clinical activity, predictive biomarkers and pharmacokinetics/ pharmacodynamics of durvalumabin combination with R-CHOP (Arm A) or R2-CHOP (Arm B), followed by durvalumab consolidation therapy in previously untreated subjects with high-risk DLBCL.

Eligibility

CD20+ Diffuse Large B-Cell Lymphoma with Ann Arbor stage 3 or 4 or stage 2 bulky disease. Must be high or high-intermediate disease risk with no prior anti-lymphoma treatment

Learn more about this study.

Genentech WO30070 

Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma (IMvigor130)

Purpose

A Phase III, randomised study of atezolizumab alone and in combination with chemotherapy versus chemotherapy alone in participants with untreated advanced urothelial cancer.

Eligibility

Histologically confirmed locally advanced or metastatic urothelial carcinoma, with no prior chemotherapy. Must have measurable disease. Prior local intravesical chemotherapy or immunotherapy is allowed if completed at least 4 weeks prior to initiation of study treatment.

Learn more about this study.

CanStem111P 

A Study of Napabucasin Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma (CanStem111P)

Purpose

This is a randomized, open-label, multi-center, phase 3 study of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine for adult patients with Metastatic Pancreatic Ductal Adenocarcinoma.

Eligibility

Must have histologically or cytologically confirmed PDAC that is metatstatic. May not have received any prior lines of therapy for metastatic PDAC unless done in the adjuvant setting > 6 months ago.

Learn more about this study.

Nanocarrier NC-6300-001 

Dose-Escalation and Expansion Trial of NC-6300 in Patients With Advanced Solid Tumors or Soft Tissue Sarcoma

Purpose

The goal of this study is to find the highest tolerated dose of NC-6300 that can be given to patients with advanced solid tumors or soft tissue sarcoma. The safety and tolerability of the drug will also be studied.

Eligibility

Must have histologically or cytologically confirmed diagnosis of advanced solid tumor or sarcoma that is refractory to standard therapy. Must have measurable disease.

Learn more about this study.

For more information about cancer-related clinical trials, call (260) 425-6800 and ask to speak to a clinical research coordinator. You may also e-mail oncologyresearch@parkview.com.

Parkview Cancer Institute
11050 Parkview Circle
Fort Wayne, Indiana 46845

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