NCI CTEP-Approved Trials for the Month of July

The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month. For further information, contact the principal investigator listed.

Phase I

ADVL1314: A Phase 1 Study of Eribulin Mesylate (E7389, IND#116,292), a Novel Microtubule Targeting Chemotherapeutic Agent in Children with Refractory or Recurrent Solid Tumors (Excluding CNS), Including Lymphomas. COG Phase 1 Consortium; Schafer, Eric Stephen. (832) 825-4241

ADVL1315: A Phase 1 Study of the VEGF Receptor Tyrosine Kinase Inhibitor Axitinib (INLYTA, IND# TBD) in Children with Recurrent or Refractory Solid Tumors. COG Phase 1 Consortium; Geller, James Ian. (513) 636-6312

Phase I/II

EA2131: A Phase I and Randomized, Double-Blinded Phase II Study of Nab-Paclitaxel/Gemcitabine Plus AZD1775 or Placebo in Treatment-Naïve Metastatic Adenocarcinoma of the Pancreas. ECOG-ACRIN Cancer Research Group; Chee, Cheng Ean. (216) 844-8609

Phase II

9604: Perfusion CT as Predictive Biomarker in a Phase II Study of Ziv-Aflibercept in Patients with Advanced Pancreatic Neuroendocrine Tumors. MD Anderson Cancer Center; Yao, James C. (713) 792-2828

S1300: A Randomized, Phase II Trial of Crizotinib Plus Pemetrexed Versus Pemetrexed Monotherapy in ALK-Positive Non-Squamous NSCLC Patients Who Have Progressed Systemically After Previous Clinical Benefit From Crizotinib Monotherapy. SWOG; Camidge, David Ross. (720) 848-0449

S1320: A Randomized Phase II Trial of Intermittent Versus Continuous Dosing of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAF V600E/K Mutant Melanoma. SWOG; Algazi, Alain Patrick. (415) 353-7552

Phase II/III

ARST1321: Pazopanib Neoadjuvant Trial in Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib (NSC# 737754, IND# 118613). Children’s Oncology Group; Weiss, Aaron Robert. (207) 396-7565

S1400: Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer. SWOG; Papadimitrakopoulou, Vassiliki A. (713) 792-6363

S1400A: A Phase II/III Randomized Study of MEDI4736 Versus Chemotherapy as Second Line Therapy for Patients with Squamous Cell Lung Cancer and No Matching Biomarkers. SWOG; Papadimitrakopoulou, Vassiliki A. (713) 792-6363

S1400B: A Phase II/III Randomized Study of GDC-0032 Versus Chemotherapy as Second Line Therapy for Biomarker Selected Patients with Squamous Cell Lung Cancer. SWOG; Papadimitrakopoulou, Vassiliki A. (713) 792-6363

S1400C: A Phase II/III Randomized Study of Palbociclib Versus Chemotherapy as Second Line Therapy for Biomarker Selected Patients with Squamous Cell Lung Cancer. SWOG; Papadimitrakopoulou, Vassiliki A. (713) 792-6363

S1400D: A Phase II/III Randomized Study of AZD4547 Versus Chemotherapy as Second Line Therapy for Biomarker Selected Patients with Squamous Cell Lung Cancer. SWOG; Papadimitrakopoulou, Vassiliki A. (713) 792-6363

S1400E: A Phase II/III Randomized Study of Rilotumumab Plus Erlotinib Versus Erlotinib as Second Line Therapy for Biomarker Selected Patients with Squamous Cell Lung Cancer. SWOG; Papadimitrakopoulou, Vassiliki A. (713) 792-6363

Phase III

AMC-A01: ANCHOR Study: Anal Cancer/HSIL Outcomes Research Study. AIDS-Associated Malignancies Clinical Trials Consortium; Palefsky, Joel. (415) 476-1574

NSABP-B-55: A Randomised, Double-Blind, Parallel Group, Placebo-Controlled Multi-Centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy. NRG Oncology; Geyer, Charles Edward. (804) 628-6435

Other Phases

A151202: Development of Predictive and Prognostic Blood-Based Biomarkers in Men with Castration-Resistant Prostate Cancer in CALGB 90401. Alliance for Clinical Trials in Oncology; George, Daniel James. (919) 668-4615

AAML14B5-Q: Efficacy of CFB-SMMHC Inhibitor in Inv16 AML Cells. Children’s Oncology Group; Castilla, Lucio H. (508) 856-3281

AOST14B1-Q: Probing the Alternative Lengthening of Telomeres ALT Pathway in Osteosarcoma. Children’s Oncology Group; Flynn, Rachel Litman. (617) 638-4346

GOG-ELD1301: Pre-Operative Assessment and Post-Operative Outcomes of Elderly Women with Gynecologic Cancers. NRG Oncology; Ahmed, Amina. (847) 723-8180

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NCI CTEP-Approved Trials for the Month of July

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Anthony Letai reflects on Year One as NCI Director: “The NCI is in business”

With Year One metrics in hand, Letai is ready to “bring it home” in Year Two
“I hope I don’t see any more reports of NCI cutting funding, because it just is not consistent with the facts”

Michael Caputo appointed to President’s Cancer Panel
The cancer survivor and political operative says his appointment signals Trump’s interest in cancer, survivorship

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So far, 38 million patients have received a dense breast notification. Now what?

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“Because it works in one neural system, you begin to wonder: Well, what about another?”

ASCO Genitourinary Cancers Symposium: Pioneering breakthroughs, optimizing patient outcomes

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NCI CTEP-Approved Trials for the Month of July

YOU MAY BE INTERESTED IN

Anthony Letai reflects on Year One as NCI Director: “The NCI is in business”

With Year One metrics in hand, Letai is ready to “bring it home” in Year Two“I hope I don’t see any more reports of NCI cutting funding, because it just is not consistent with the facts”

Michael Caputo appointed to President’s Cancer PanelThe cancer survivor and political operative says his appointment signals Trump’s interest in cancer, survivorship

Two years after FDA’s breast density notification rule, there is still no standard for follow-upSo far, 38 million patients have received a dense breast notification. Now what?

MD Anderson study suggests psilocybin may prevent chemo-induced neuropathy“Because it works in one neural system, you begin to wonder: Well, what about another?”

ASCO Genitourinary Cancers Symposium: Pioneering breakthroughs, optimizing patient outcomes

Never miss an issue!

Login

With Year One metrics in hand, Letai is ready to “bring it home” in Year Two
“I hope I don’t see any more reports of NCI cutting funding, because it just is not consistent with the facts”

Michael Caputo appointed to President’s Cancer Panel
The cancer survivor and political operative says his appointment signals Trump’s interest in cancer, survivorship

Two years after FDA’s breast density notification rule, there is still no standard for follow-up
So far, 38 million patients have received a dense breast notification. Now what?

MD Anderson study suggests psilocybin may prevent chemo-induced neuropathy
“Because it works in one neural system, you begin to wonder: Well, what about another?”