SCCA Clinical Studies: Phase 1 Program

Phase I studies are critical to future patients and the health-care industry. Potentially speeding the development of new therapies, phase I studies require a high level of unique technical and scientific competencies, like those found at SCCA’s Phase I Cancer Clinical Trials Program.

Located in the Clinical Trials Unit (CTU) at SCCA, our program’s researchers have access to leading research facilities at Fred Hutchinson Cancer Research Center, the source of multiple medical breakthroughs and home to Nobel Prize winning researchers, and University of Washington Medicine where advanced technologies such as positron emission tomography (PET) and other essential tools support thorough research studies.

We're currently enrolling patients into the following trials:

All solid tumor malignancies

• LDK378 for Tumors with ALK Mutation
  A Dose Finding Study With Oral LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase (ALK).
• PF-05082566 for Advanced Cancer or B-Cell Lymphoma
  A Phase 1 Study Of PF-05082566 As A Single Agent In Patients With Advanced Cancer, And In Combination With Rituximab In Patients With Non-Hodgkin's Lymphoma (NHL)
• LY2157299 for Metastatic Cancer and Advanced or Metastatic Pancreatic Cancer
  A Phase 1b/2 Study With Gemcitabine and LY2157299 for Patients With Metastatic Cancer (Phase 1b) and Advanced or Metastatic Unresectable Pancreatic Cancer (Phase 2)
• RO5429083 Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors
  Open-Label Multicenter 2-Arm Phase I Study of RO5429083 With Dose-Escalation and Extension Cohorts, and Imaging Cohorts With RO5429083 and 89Zr-labeled RO5429083, in Patients With Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors

Breast Cancer

• PARP Inhibitor ABT-888 with Carboplatin & Gemcitabine  (M10-758)
  A Phase 1 Study of ABT-888 in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors.
• PARP Inhibitor ABT-888 with Cisplatin and Vinorelbine
  Phase I Study of ABT-888 in Combination With Cisplatin and Vinorelbine for Patients With Advanced Triple Negative Breast Cancer and/or BRCA-Mutation Associated Breast Cancer.
• MLN8237, an Aurora A Kinase Inhibitor w/ Weekly Paclitaxel (C14008)
  Phase 1 Study of MLN8237, an Aurora A Kinase Inhibitor, Plus Weekly Paclitaxel in Patients with Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer or breast cancer.
• MDX-1105 for Advanced or Recurrent Cancer (MDX1105-01)
  A Phase 1, Open-label, Dose-escalation, Multidose Study of MDX-1105 Administered Every 14 Days in Subjects With Selected Advanced or Recurrent Solid Tumors. 

GI Cancer 

• PARP Inhibitor ABT-888 with Carboplatin & Gemcitabine  (M10-758)
  A Phase 1 Study of ABT-888 in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors.
• LY2157299 for Metastatic Cancer and Advanced or Metastatic Pancreatic Cancer
  A Phase 1b/2 Study With Gemcitabine and LY2157299 for Patients With Metastatic Cancer (Phase 1b) and Advanced or Metastatic Unresectable Pancreatic Cancer (Phase 2)
• MDX-1105 for Advanced or Recurrent Cancer (MDX1105-01)
  A Phase 1, Open-label, Dose-escalation, Multidose Study of MDX-1105 Administered Every 14 Days in Subjects With Selected Advanced or Recurrent Solid Tumors. 
• PEGPH20 for Stage IV Previously Untreated Pancreatic Cancer
  A Phase 1b/2 Multicenter, International, Randomized, Double Blind, Placebo-Controlled, Study of Gemcitabine Combined with PEGPH20 (PEGylated Recombinant Human Hyaluronidase) Compared to Gemcitabine Combined with Placebo in Patients with Stage IV Previously Untreated Pancreatic Cancer.

 GU Cancer

• PARP Inhibitor ABT-888 with Carboplatin & Gemcitabine  (M10-758)
  A Phase 1 Study of ABT-888 in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors.
• Dose-Escalation Study of MLN9708 (C16001) (UW08039)
  An Open-Label, Dose Escalation, Phase 1 Study of MLN9708, a Second-Generation Proteasome Inhibitor, in Adult Patients With Advanced Nonhematologic Malignancies.
   

Gynecologic Cancer

• MDX-1105 for Advanced or Recurrent Cancer (MDX1105-01)
  A Phase 1, Open-label, Dose-escalation, Multidose Study of MDX-1105 Administered Every 14 Days in Subjects With Selected Advanced or Recurrent Solid Tumors. 
• PARP Inhibitor ABT-888 with Carboplatin & Gemcitabine  (M10-758)
  A Phase 1 Study of ABT-888 in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors.
• MLN8237, an Aurora A Kinase Inhibitor w/ Weekly Paclitaxel (C14008)
  Phase 1 Study of MLN8237, an Aurora A Kinase Inhibitor, Plus Weekly Paclitaxel in Patients with Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer or breast cancer.
  

Head & Neck Cancer

• Dose-Escalation Study of MLN9708 (C16001) (UW08039)
  An Open-Label, Dose Escalation, Phase 1 Study of MLN9708, a Second-Generation Proteasome Inhibitor, in Adult Patients With Advanced Nonhematologic Malignancies.

Hematologic Malignancies

• PF-05082566 for Advanced Cancer or B-Cell Lymphoma
  A Phase 1 Study Of PF-05082566 As A Single Agent In Patients With Advanced Cancer, And In Combination With Rituximab In Patients With Non-Hodgkin's Lymphoma (NHL)
• TRU-016 w/ Rituximab and Bendamustine for Lymphoma
  A Phase 1b/2 Study of TRU-016 in Combination With Rituximab and Bendamustine in Subjects With Relapsed Indolent Lymphoma
• PF-04449913 for Hematologic Malignancies (B1371001)
  A Phase 1 Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of PF-04449913, An Oral Hedgehog Inhibitor, Administered As Single Agent In Select Hematologic Malignancies Or In Combination With Dasatinib In Chronic Myeloid Leukemia (CML)
• SGN-75 for Lymphoma or Renal Cell Carcinoma (SGN75-001)
  A Phase 1, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of SGN-75 in Patients With CD70-positive Relapsed or Refractory Non-Hodgkin Lymphoma or Metastatic Renal Cell Carcinoma. 
• SGN-35 for Lymphoma (UW 09043)
  An Open-Label Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35) in Patients With CD30-Positive Hematologic Malignancies: CYP3A4 Drug-Drug Interactions, Excretion, and Special Populations
• Oral LDK378 for Patients With ALK-positive Tumors
  A Dose Finding Study With Oral LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase (ALK).
• Oral BMN 673 for Advanced Hematological Malignancies
  Phase 1, Two-arm, Open-label Study of Once Daily, Oral BMN 673 in Patients With Advanced Hematological Malignancies.
• GA101 (RO5072759) for Previously Untreated Chronic Lymphocytic Leukemia
  An Open-Label, Multicenter, Phase Ib Trial of GA101 (RO5072759) in Combination With Chemotherapy in Patients With Previously Untreated Chronic Lymphocytic Leukemia
• Inotuzumab Ozogamicin for Acute Lymphocytic Leukemia
  An Open-Label, Phase 1 Study Of Inotuzumab Ozogamicin In Subjects With Relapsed Or Refractory CD22-Positive Acute Lymphocytic Leukemia

Lung Cancer

• MDX-1105 for Advanced or Recurrent Cancer (MDX1105-01)
  A Phase 1, Open-label, Dose-escalation, Multidose Study of MDX-1105 Administered Every 14 Days in Subjects With Selected Advanced or Recurrent Solid Tumors. 
• Oral LDK378 for Patients With ALK-positive Tumors
  A Dose Finding Study With Oral LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase (ALK).

Melanoma

• ALT-801 Plus Cisplatin for Melanoma (CA-ALT-801-02-09)
  Phase Ib/II Study of ALT-801 With Cisplatin in Patients With Metastatic Melanoma. 
  
• MLN4924 for Metastatic Melanoma (C15005)
  A Phase I, Open-Label, Dose Escalation Study of MLN4924, a Novel Inhibitor of Nedd8-Activating Enzyme, in Adult Patients With Melanoma.

Renal Cancer

• AGS-16M8F for Advanced Renal Cancer
  A Phase 1, Open-label, Multi-center, Dose Escalation Study of the Safety and Pharmacokinetics of AGS-16M8F Monotherapy in Subjects With Advanced Renal Cell Carcinoma