STAR Trials

The US Oncology Research STAR model (Selected Trial for Accelerated Rollout) are a set of studies targeted for rare patient populations.  Trials in the STAR program can be made available for consenting patients within a 2-week time frame after a potential research patient has been identified and sponsor has given approval to move forward.  Southern Cancer Center is given visibility to the trials included in this rapid activation model.

 

STAR TRIALS CURRENTLY OPEN

Anal Cancer
USOR # 20189

A Phase 3 Global, Multicenter, Double-Blind Randomized Study of Carboplatin-Paclitaxel With INCMGA00012 or Placebo in Participants With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal Not Previously Treated With Systemic Chemotherapy – STAR Ph3 Carbo/Pac NCMGA00012 MSCC

USOR # 19151

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation (849-001) – STAR Ph1/2 MRTX849 Solids KRAS G12C

 

Biliary Cancer
USOR # 18264

A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib versus Gemcitabine with Cisplatin in Subjects with Advanced/Metastatic or Inoperable Cholangiocarcinoma with FGFR2 Gene Fusions/Translocations: The PROOF Trial (QBGJ398-301) – STAR Infigratinib vs Gem/Cis Cholangio

 

Bladder Cancer
USOR # 18033

A Phase 2 Study of Sitravatinib in Combination with PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma (516-003) – STAR Sitra+Nivo/Pembro+Enfor Adv/Met Uro

USOR # 19151

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation (849-001) – STAR Ph1/2 MRTX849 Solids KRAS G12C

USOR # 20172

A study of enfortumab vedotin (ASG-22CE) as monotherapy or in combination with other anticancer therapies for the treatment of urothelial cancer (SGN22E-002) Locally Advanced or Metastatic – PH 2 ASG-22CE Urothelial Ca- locally advanced

 

Breast Cancer
USOR # 14059

Phase I/II trial of Ibrutinib plus Trastuzumab in HER2-amplified Metastatic Breast Cancer – STAR Ph1/2 Ibrutinib+Tras HER2 amp/MBC

USOR # 19054

Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic HER2+ breast cancer (HER2CLIMB-02)(SGNTUC-016) – STAR Ph 3 Tuca/Placbo + T-DM1 HER2+

 

Carcinoid
USOR # 20189

A Phase 3 Global, Multicenter, Double-Blind Randomized Study of Carboplatin-Paclitaxel With INCMGA00012 or Placebo in Participants With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal Not Previously Treated With Systemic Chemotherapy (POD1UM-303/InterAACT 2) (INCMGA 0012-303) – STAR Ph3 Carbo/Pac NCMGA00012 MSCC

 

Cervical Cancer
USOR # 20225

A Phase 2, multicenter, single-arm, open-label study to evaluate the efficacy and safety of AK104 in subjects with recurrent or metastatic cervical cancer (AK104-201-AU) – STAR Ph2 Ak104 Cervical Cancer- mets

 

Colon Cancer
USOR # 20216

A Phase 2, Open Label Study of Tucatinib Combined with Trastuzumab in Patients with HER2+ Metastatic Colorectal Cancer (ACCRU-GI-1617, SGNTUC-017) – STAR: PH2 Tuca+ Tras HER2+ CC

 

Esophageal Cancer
USOR # 19151

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation (849-001) – STAR Ph1/2 MRTX849 Solids KRAS G12C

USOR # 20171

A Multicenter, Double-Blind, Randomized Phase III Clinical Trial Evaluating the Efficacy and Safety of Sintilimab vs. Placebo, in Combination with Chemotherapy, for First-Line Treatment of Unresectable, Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma (ORIENT-15)CIBI308A301 – STAR Ph3 Sinti vs Placebo ESCC

 

Essential Thrombocythemia
USOR # 19171

A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician’s Choice in Patients with Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia (Platelets Counts <50,000/µL) (PAC203) – STAR PH3 Pacritinib vs MD choice in MF

 

Leukemia (CLL)
USOR # 16213

A Multi-Center, Open-Label, Compassionate Use Extension Study of Ublituximab (TG-1101) in Combination with Umbralisib (TGR-1202) for Patients Previously Enrolled in Protocol UTX-TGR-304 – STAR Ublituximab+TGR-1202 Cross-over

 

Lung
USOR # 18129

A Phase 3 Randomized Open-label Study of Brigatinib (ALUNBRIG™) Versus Alectinib (ALECENSA®) in Advanced Anaplastic Lymphoma Kinase-Positive Non–Small-Cell Lung Cancer Patients Who Have Progressed on Crizotinib (XALKORI®) – STAR Ph3 ALK+ mNSCLC (Brigatinib-3001)

USOR # 18164

A Phase 1/2 Study of the Highly-selective RET Inhibitor, BLU-667, in Patients with Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC), and Other Advanced Solid Tumors – STAR Ph1/2 BLU667 thy, NSCLC, Sol tum

USOR # 19239

A Phase 2, Randomized, Multicenter, Double-blind, Study of the Glutaminase Inhibitor Telaglenastat with Pembrolizumab and Chemotherapy versus Placebo with Pembrolizumab and Chemotherapy in First-line Metastatic KEAP1/NRF2-mutated Nonsquamous, Non-Small Cell Lung Cancer (NSCLC) – STAR KEAP1/NRF2 NSCLC

USOR # 20249

A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared with Carboplatin-Pemetrexed, in Patients with EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (61186372NSC3001) – Ph 3 JNJ-61186372 Peme EGFR NSCLC

USOR # 19208

A Randomized, Open-Label, Phase 3 Study of Pralsetinib versus Standard of Care for First Line Treatment of RET fusion-positive, Metastatic Non-Small Cell Lung Cancer (BLU-667-2303) – STAR-PH3 pral(Blu-667) RET-fusion mNSCLC

 

Lymphoma (Hodgkins)
USOR #11282

A phase 2 open-label study of brentuximab vedotin in front-line therapy of Hodgkin lymphoma (HL) and CD30-expressing peripheral T-cell lymphoma (PTCL) in older patients or patients with significant comorbidities ineligible for standard chemotherapy – STAR BV in older pts w/1L cHL or PTCL

USOR #18013

Multiple Part Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma Subjects – STAR Ph2 A+AVD +G-CSF or AOAD in CHL

 

Myelofibrosis
USOR #20177

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Navitoclax in Combination with Ruxolitinib versus Ruxolitinib in Subjects with Myelofibrosis (TRANSFORM-1) – STAR Ph3 Navi Ruxo Myelofibrosis

USOR #19171

A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician’s Choice in Patients with Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia (Platelets Counts <50,000/µL) (PAC203) – STAR PH3 Pacritinib vs MD choice in MF

 

Prostate Cancer
USOR #18103

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Subjects with Metastatic Prostate Cancer(64091742PCR3001) – STAR Ph3 Nirap+Abirat+Pred mCRPC

USOR #19151

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation (849-001) – STAR Ph1/2 MRTX849 Solids KRAS G12C

USOR #16238

A Multicenter, Randomized, Open-label Phase 3 Study of Rucaparib versus Physician’s Choice of Therapy for Patients with Metastatic Castration-resistant Prostate Cancer Associated with Homologous Recombination Deficiency (CO-338-063) – STAR Rucaparib v PhysC mCRPC (TRITON3)

USOR #20248

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants with Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)(67652000PCR3002) – STAR PH3 Nirap Abira HRR mCSPC

 

Rectal Cancer
USOR # 19151

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation (849-001) – STAR Ph1/2 MRTX849 Solids KRAS G12C

USOR # 20216

A Phase 2, Open Label Study of Tucatinib Combined with Trastuzumab in Patients with HER2+ Metastatic Colorectal Cancer (ACCRU-GI-1617, SGNTUC-017) – STAR: PH2 Tuca+ Tras HER2+ CC

 

Solid Tumors
USOR # 18164

Phase 1/2 Study of the Highly-selective RET Inhibitor, BLU-667, in Patients with Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC), and Other Advanced Solid Tumors – STAR Ph1/2 BLU667 thy, NSCLC, Sol tum

USOR # 19079

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207) – STAR Ph2 Pemigatinib Solids FGFR

USOR # 19092

A Phase 2 Study of Erdafitinib in Subjects With Advanced Solid Tumors and FGFR Gene Alterations (42756493CAN2002) – STAR Ph2 Erdafitinib FGFR Solid Tumors

USOR # 19151

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation (849-001) – STAR Ph1/2 MRTX849 Solids KRAS G12C

 

Thyroid Cancer
USOR # 18164

A Phase 1/2 Study of the Highly-selective RET Inhibitor, BLU-667, in Patients with Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC), and Other Advanced Solid Tumors – STAR Ph1/2 BLU667 thy, NSCLC, Sol tum

USOR # 19151

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation (849-001) – STAR Ph1/2 MRTX849 Solids KRAS G12C

 

Urothelial Cancer
USOR # 17133

A Phase 3 Study of Erdafitinib Compared with Vinflunine or Docetaxel or Pembrolizumab in Subjects with Advanced Urothelial Cancer and Selected FGFR Gene Aberrations (THOR) – STAR Ph3 FGFR erdafitinib urothelial

USOR # 18033

A Phase 2 Study of Sitravatinib in Combination with PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma (516-003) – STAR Sitra+Nivo/Pembro+Enfor Adv/Met Uro

USOR # 19094

Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations (PROOF302) – STAR Ph 3 Infigratinib UC w/ FGFR3 Alt

USOR # 19151

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation (849-001) – STAR Ph1/2 MRTX849 Solids KRAS G12C

USOR # 20172

A study of enfortumab vedotin (ASG-22CE) as monotherapy or in combination with other anticancer therapies for the treatment of urothelial cancer (SGN22E-002) – STAR PH 2 ASG-22CE Urothelial Cancer

 

 

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