Dr. Charles Geyer, Jr., President & CMO of the Statewide Clinical Trials Network of Texas (CTNeT) discusses CTNeT (Statewide Clinical Trials Network of Texas) and its role in Building Texas' Life Sciences Infrastructure; Getting the Most Promising Science to the Most People at the 2012 CPRIT Innovation in Cancer Conference

1. Building Texas’ Life Science
Infrastructure
Charles E. Geyer, Jr., MD
President and CMO
Innovations in Cancer Research and
Prevention Conference
CPRIT 2012

2. Creation of CTNeT
 CPRIT infrastructure grant established CTNeT to
facilitate and coordinate the conduct of statewide
clinical trials in cancer – Applied Science
 Main scientific tenets:
• Conduct statewide, tissue-based and biomarker-driven
clinical trials focused on advancing targeted, more
personalized care for cancer
• Collaborate closely with the CPRIT-funded Texas Cancer
Research Biobank (TCRB)
• Implement efficient and scalable cancer clinical trials
model to rapidly develop, activate, conduct and analyze
high quality clinical trials

3. Vision of CTNeT
 Improve access of Texans with cancers that are
considered incurable to promising new cancer
treatments by providing:
• extensive genetic analyses of their tumors to
identify targets of new drugs in development
• statewide clinical trials of new drugs targeting
genetic abnormalities identified as possible key
drivers of their cancers
• statewide clinical trials evaluating new drugs in
rare malignancies including childhood cancers

4. Chronic Myeloid Leukemia

5. Chronic Myeloid Leukemia
Translocation – Dominant Driver Gene
Legend
BCR-Abl
fusion gene - 99%

6. Breast Cancer

7. Breast Cancer
Amplification – Dominant Driver Gene
Legend
HER2
Amplification - 15%

8. Lung Cancer

9. Lung Cancer
Array of Low Frequency Genetic Alterations
Legend
EGFR
mutation - 14%
KRAS
mutation - 24%
EML4-ALK
translocation - 4%
MET
aberration - 15%
KIF5B RET
translocation - 2%
BRAF
mutation - 2%

10. Lung Cancer
Clinical Trial Targeting MET Aberrant Disease
Legend
MET
aberrations

11. Lung Cancer
Clinical Trial Targeting MET Aberrant Disease
Legend
MET
mutation or
overexpression
MET
amplification

12. Lung Cancer
Clinical Trial Targeting MET Aberrant Disease
Legend
MET mutation MET
or overexpression amplification

13. Lung Cancer
Clinical Trial Targeting KRAS Mutant Disease
Legend
KRAS
mutation

14. Lung Cancer
Clinical Trial Targeting KRAS Mutant Disease
Legend
KRAS mutation
TS gene 1 wild
TS gene 2 wild
KRAS mutation
TS gene 1 mutant
TS gene 2 wild
KRAS mutation
TS gene 1 wild
TS gene 2 mutant

15. Lung Cancer
Clinical Trial Targeting KRAS Mutant Disease
Legend
KRAS mutation KRAS mutation KRAS mutation
TS gene 1 wild TS gene 1 mutant TS gene 1 wild
TS gene 2 wild TS gene 2 wild TS gene 2 mutant

16. Lung Cancer
Trial Targeting KIF5B RET Translocation
Legend
KIF5B RET
translocation

17. KIF5B RET Inhibitor Clinical Trial

18. BRAF V600E Inhibitor Clinical Trial

19. Single Molecular Characterization Protocol

20. Molecular Characterization Infrastructure
Tissue Results
Patient Patient submitted reported CTNeT
Consent Registration Members
Tissue stored for All test results stored
future research in data warehouse
Communication with
site for future
CTNeT potential studies
Biorepository
Operations

21. Members of CTNeT
BAYLOR COLLEGE of MEDICINE UT HEALTH SCIENCE CENTER AT HOUSTON
CANCER CARE CENTERS of SOUTH TEXAS UT HEALTH SCIENCE CENTER at SAN ANTONIO
CENTER for CANCER and BLOOD DISORDERS UT HEALTH SCIENCE CENTER AT TYLER
MARY CROWLEY CANCER RESEARCH CENTER UT MD ANDERSON CANCER CENTER
MEMORIAL HERMANN CANCER CENTER UT MEDICAL BRANCH at GALVESTON
THE METHODIST HOSPITAL SYSTEM UT SOUTHWESTERN MEDICAL CENTER
ONCOLOGY CONSULTANTS, PA TEXAS CHILDREN’S CANCER CENTER
SCOTT & WHITE HEALTHCARE TEXAS ONCOLOGY
SOUTH TEXAS ONCOLOGY HEMATOLOGY AT START CENTER
TEXAS TECH HEALTH SCIENCES CENTER / COVENANT HEALTH SYSTEM

22. Initial Portfolio of Studies
 Tissue Procurement and Molecular Testing:
• Procurement and Molecular Characterization of Existing FFPE
Tumor Samples to Identify Biomarker-Based Cohorts of
Patients as Potential Candidates for Clinical Trials (N=2,500)

23. Initial Portfolio of Studies
 Clinical Studies:
• Phase II study of MET inhibition in previously treated NSCLC,
SCCHN and TNBC with MET aberrations (N=72)
Study Co-chairs - George R. Blumenschein, Jr., MD and
Ana M. Gonzalez-Angulo, MD, MSc (MDACC)
• Phase II study of FAK inhibition in KRAS mutant NSCLC (N=114)
Study Co-chairs - David E. Gerber, MD
and Pier Paolo Scaglioni, MD (UTSW)
• Phase II study of RET inhibition in KIF5B-RET-positive
adenocarcinoma of the lung (N=20)
• Phase II study of BRAF inhibition in BRAF V600E mutant
adenocarcinoma of the lung (N=40)

24. Initial Portfolio of Studies
 Clinical Studies (continued):
• Phase II study of dual MEK1 and FLT3 inhibition in
relapsed/refractory AML with FLT3 and/or RAS mutation (N=60)
Study Co-chairs - Gautam Borthakur, MD and
Jorge E. Cortes, MD (MDACC)
• Phase I/II study of combination of anti-CD22 antibody-
chemotherapy conjugate with lower-intensity chemotherapy in
elderly patients with ALL (N=66)
Study Chair – Hagop M Kantarjian, MD (MDACC)
• A Phase II, Multicenter, Single-Arm Study of G-202 as Second-
Line Therapy Following Sorafenib for Adult Patients with
Progressive Advanced Hepatocellular Carcinoma (N=29)
Study Chair - Devalingam Mahalingam, MD, PhD
(CTRC at UTHSC San Antonio)