Clinical Trials Supported by Accelerating Clinical Trials of Novel Oncologic PathWays (ACTNOW) Initiative
ACTNOW is an early-phase clinical trial program designed to help shorten the time it takes to move new cancer treatments from the discovery phase, to drug development, and, ultimately, to approval and safe use by cancer patients.
The table below lists the ACTNOW trials by cancer type, and contains links to descriptions of the drugs being studied, the trial objectives, patient enrollment criteria, and locations where patients receive treatment.
| Disease(s) | Study Drug / Therapy | Protocol ID / Title | Lead Organization |
|---|---|---|---|
| Brain tumor | Cediranib | Laboratory and imaging studies related to 8030, Phase I/II Study of Cediranib, Temozolomide, and Radiotherapy in Patients With Newly Diagnosed Glioblastoma | Massachusetts General Hospital, Dana-Farber Cancer Institute |
| Brain tumor | Cediranib Cilengitide | ABTC-0903 A Phase Ib Study of Cediranib in Combination with Cilengitide in Patients with Recurrent Glioblastoma | Adult Brain Tumor Consortium |
| Brain tumor | GDC-0449 | ABTC-0904 A Biomarker and Phase II Study of GDC-0449 in Patients with Recurrent Glioblastoma Multiforme | Adult Brain Tumor Consortium |
| Brain tumor | GDC-0449 | PBTC-025B A Phase II Clinical Trial Evaluating the Efficacy and Safety of GDC-0449 in Adults with Recurrent or Refractory Medulloblastoma | Pediatric Brain Tumor Consortium |
| Brain tumor | ABT-888 | PBTC-027 A Phase I Study of ABT-888, an Oral Inhibitor of Poly (ADP-ribose) Polymerase and Temozolomide in Children with Recurrent/Refractory CNS Tumors | Pediatric Brain Tumor Consortium |
| Brain tumor | GDC-0449 | PBTC-025 A Phase I Pharmacokinetic and Safety Study in Children with Recurrent or Refractory Medulloblastoma to Identify a Pharmacokinetic Based Dose for GDC-0449 | Pediatric Brain Tumor Consortium |
| Brain tumor | 18F- fluoromisonidazole (FMISO) as imaging agent | ACRIN-6684 Multicenter Phase II Assessment of Tumor Hypoxia in Glioblastoma Using 18F-Fluoromisonidazole (FMISO) with PET and MRI | American College of Radiology Imaging Network (ACRIN), with Brown University as biostatistics center |
| Breast cancer and other solid tumors | 1-Methyl-d-tryptophan Ad.p53 DC vaccine | MCC-16025 A phase 1/2 study of Ad.p53 DC vaccine in combination with 1-methyl-D-tryptophan in metastatic solid tumors and invasive breast cancer | Moffitt Cancer Center and Research Institute |
| Breast cancer | Bevacizumab | CALGB-40603 Randomized Phase II 2 x 2 Factorial Trial of the Addition of Carboplatin +/- Bevacizumab to Neoadjuvant Weekly Paclitaxel Followed by Dose-Dense AC in Hormone Receptor-Poor/HER2-Negative Resectable Breast Cancer | Cancer and Leukemia Group B |
| Breast cancer | Bevacizumab | SWOG-S0800 A Randomized Phase II Trial of Weekly Nanoparticle Albumin Bound Paclitaxel (Nab-Paclitaxel) (NSC-736631) With or Without Bevacizumab, Either Preceded By Or Followed By Q 2 Week Doxorubicin (A) And Cyclophosphamide (C) Plus Pegfilgrastim (Peg-G) as Neoadjuvant Therapy for Inflammatory and Locally Advanced Her-2/Neu Negative Breast Cancer | Southwest Oncology Group (SWOG) |
| Breast cancer | GDC-0449 RO4929097 | 2009-099 A Phase I Study of the Hedgehog Smoothened Antagonist GDC-0449 (NSC # 747691) Plus Pan-Notch Inhibitor RO4929097 (NSC # 749225) Administered in Patients with Advanced Breast Cancer | Wayne State University -Barbara Ann Karmanos Cancer Institute |
| Breast and gynecologic cancers | Cediranib Olaparib | NCI # 8348, DFCI# 09293 Phase I/II study of cediranib and olaparib in combination for treatment of recurrent papillary-serous ovarian, fallopian tube, or peritoneal cancer or for treatment of recurrent triple-negative breast cancer | Dana-Farber Cancer Institute |
| Breast and gynecologic cancers | ABT-888 | UPCI 08-121 A Phase 1 Study of Chronically-Dosed, Single-Agent ABT-888 in Patients with BRCA ½ -Mutated Cancer; Platinum-Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer; or Basal-Like Breast Cancer | University of Pittsburgh Medical Center (UPMC) |
| Germ-cell cancers | Alvocidib | MSKCC-09034 A Non-Randomized Phase 2 Study of Alvocidib (Flavopiridol) Plus Oxaliplatin with or without 5-FU and Leucovorin for Relapsed or Refractory Germ-Cell Tumors | Memorial Sloan-Kettering Cancer Center |
| Gynecologic cancers | ABT-888 Bevacizumab | GOG-9923 A Phase I Study of Carboplatin/Paclitaxel/CTEP Supplied Agent Bevacizumab (NSC #704865, IND #7921) and CTEP Supplied Agent ABT-888 (NSC #737664 IND#77840) in Newly Diagnosed Patients with Previously Untreated Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer | Gynecologic Oncology Group |
| Gynecologic cancers | Ixabepilone Bevacizumab Temsirolimus | GOG-0086P A Three Arm Randomized Phase II Study of Paclitaxel/Carboplatin/Bevacizumab (NSC#704865, IND#7921), Paclitaxel/Carboplatin/Temsirolimus (NSC#683864, IND#61010) and Ixabepilone (NSC#710428, IND#59699)/ Carboplatin/Bevacizumab as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer | Gynecologic Oncology Group |
| Hodgkin lymphoma | Therapy adapted to results of PET scans | SWOG-S0816 A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging | Southwest Oncology Group |
| Leukemia | Vorinostat Gemtuzumab Ozogamicin Azacitidine | FHCRC -2288.00 A Phase 1/2 Study of Vorinostat (Zolinza®) in Combination with Gemtuzumab Ozogamicin (Mylotarg®) and Azacitidine (Vidaza®) in Patients 50 Years of Age and Older with Relapsed/Refractory non-APL Acute Myeloid Leukemia (AML) | Fred Hutchinson Cancer Research Center |
| Liver cancer | Sorafenib Bevacizumab | NCCTG-N0745 Phase I/II Randomized Trial of Sorafenib and Bevacizumab as First-Line Therapy in Patients with Locally Advanced or Metastatic Hepatocellular Carcinoma | North Central Cancer Treatment Group |
| Liver cancer | Cixutumumab Sorafenib | CCC-PHI-64 A Phase I Trial of Escalating Doses of the Anti-IGF-1R Monoclonal Antibody IMCA12 and Standard Dose Sorafenib for Treatment of Advanced Hepatocellular Carcinoma | California Cancer Consortium |
| Lung cancer | 18F-FLT as PET imaging agent to assess preoperative therapy | J08134 Phase II Single-Arm Trial Comparing the Use of FLT PET to Standard Computed Tomography to Assess the Treatment Response of Neoadjuvant Docetaxel and Cisplatin in Stage IB-IIIA Resectable Non-Small Cell Lung Cancer | Johns Hopkins University |
| Lung cancer | GDC-0449 Cixutumumab | ECOG-E1508 A Randomized Phase II Study of Cisplatin and Etoposide in Combination with Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMCA12 for Patients with Extensive Stage Small Cell Lung Cancer | Eastern Cooperative Oncology Group |
| Lung cancer | Cixutumumab Cetuximab | ECOG-E4508 Three-Arm Randomized Phase II Study of Carboplatin and Paclitaxel in Combination with Cetuximab, IMC-A12 or Both in Patients With Advanced Non-Small Cell Lung Cancer Who Will Not Receive Bevacizumab-Based Therapy | Eastern Cooperative Oncology Group |
| Melanoma | AZD6244 | MSKCC-09003 Phase II Trial of Hyd-sulfate AZD6244 [NSC 748727] in Patients with BRAF or NRAS Mutated Melanomas | Memorial Sloan-Kettering Cancer Center |
| Meningioma | Radiation or observation | RTOG-0539 Phase II Trial of Observation for Low-Risk Meningiomas and of Radiotherapy for Intermediate- and High-Risk Meningiomas | Radiation Therapy Oncology Group |
| Myeloma | SCH 727965 | MC0888 Phase II Trial of Cdk Inhibitor SCH 727965 in Multiple Myeloma | Mayo Clinic Phase 2 Consortium |
| Neuroblastoma | Monoclonal Antibody CH14.18 | COG-ANBL0931 A Comprehensive Safety Trial of Chimeric Antibody 14.18 (Ch14.18) with GM-CSF, IL-2 and Isotretinoin in High-Risk Neuroblastoma Patients Following Myeloablative Therapy | Children's Oncology Group |
| Pancreatic cancer | GDC-0449 | 09-068-B A Multi-Center, Double Blind, Placebo-Controlled, Randomized Phase II of Gemcitabine Plus GDC-0449 (NSC 747691), a Hh Pathway Inhibitor, in Patients with Metastatic Pancreatic Cancer (10052747) | University of Chicago Phase 2 Consortium |
| Prostate cancer | Cixutumumab Temsirolimus | MSKCC-09117 Phase I/II Trial of Anti-IGF-IR Monoclonal Antibody IMC-A12 Plus mTOR Inhibitor Temsirolimus (CCI-779) in Metastatic Castration- Resistant Prostate Cancer (CRPC) | Memorial Sloan-Kettering Cancer Center |
| Sarcomas | Cixutumumab Temsirolimus | MSKCC-09097 A Phase II Study of Temsirolimus (CCI-779, NSC 683864) and IGF-1 Receptor Antibody IMC-A12 (NSC 742460) in Patients with Metastatic Sarcomas | Memorial Sloan-Kettering Cancer Center |
| Stomach and gastroesophageal cancers | GDC-0449 | NYCC-09-0356 A Randomized, Double Blind Placebo Controlled Phase 2 Study of FOLFOX Plus or Minus GDC-0449 in Patients with Advanced Gastric and Gastroesophageal Junction (GEJ) Carcinoma | New York University Langone Medical Center / Montefiore (NY Phase 2 Consortium) |
| Various solid tumors - Pediatric | Cixutumumab Temsirolimus | COG-ADVL0813 A Phase I Study of IMC-A12 (Anti-Insulin-Like Growth Factor-I Receptor Monoclonal Antibody) in Combination with CCI-779 (Temsirolimus) in Pediatric Patients with Recurrent or Refractory Solid Tumors | COG Phase 1 Consortium |
| Various solid tumors - Pediatric | Seneca Valley virus-001 | COG-ADVL0911 A Phase 1 Dose Escalation Study of Seneca Valley Virus (NTX-010), A Replication-Competent Picornavirus, in Relapsed/Refractory Pediatric Patients with Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors with Neuroendocrine Features | Children's Oncology Group Phase 1 Consortium |
| Various solid tumors | ABT-888 | OSU-09100 ABT-888 as monotherapy and in combination with Mitomycin C in patients with solid tumors with deficiency in homologous recombination repair | Ohio State University Medical Center |
| Various solid tumors | ABT-888 | PCI-07-015 A Phase I Study of ABT-888 in Combination with Carboplatin and Paclitaxel in Advanced Solid Malignancies | University of Pittsburgh Medical Center (UPMC)/ U Pittsburgh Cancer Institute (UPCI) |
| Various solid tumors | AZD6244 Cixutumumab | J0691 A Phase 1, Single-Institution Open Label, Dose-Escalation Trial with an Expansion Cohort Evaluating the Safety and Tolerability of AZD6244 and IMC-A12 in Subjects with Advanced Solid Malignancies | Johns Hopkins University |
| Various solid tumors | AZD6244 | 09-005 Phase II Clinical Trial of the MEK 1/2 Inhibitor AZD6244 in Cancers with BRAF Mutations Identified by Prospective Genotypic Analysis | Massachusetts General Hospital |
| Various solid tumors | Cediranib and whole brain radiation therapy | 09-089 A Phase 1 Study of AZD2171 and WBRT in Patients with Brain Metastases | Massachusetts General Hospital, Dana-Farber Cancer Institute |
