Phase I Drug Development:
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Phase I Drug Development: Early Indications of Antitumor Activity for Sarcoma Patients and Opportunities for Progress. Anthony Tolcher Director of Clinical Research Institute for Drug Development CTRC, San Antonio TX. Phase-1-ologist. Pronounced: faez ·won·ole·geest Definition:

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Anthony Tolcher Director of Clinical Research Institute for Drug Development CTRC, San Antonio TX

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Anthony tolcher director of clinical research institute for drug development ctrc san antonio tx

Phase I Drug Development:Early Indications of Antitumor Activity for Sarcoma Patients and Opportunities for Progress

Anthony Tolcher

Director of Clinical Research

Institute for Drug Development

CTRC, San Antonio TX


Phase 1 ologist

Phase-1-ologist

Pronounced: faez·won·ole·geest

Definition:

1small curious creature that inhabits Texas, Ohio, California, and occasionally Arizona.

2Exhibits animated activity when exposed to novel chemical structures or mechanisms of action

3Becomes ecstatic if one patient in 40 has response


Conventional wisdom

Conventional Wisdom

  • Focus on main indications

    • Breast, lung, colon, maybe prostate

  • Smaller pharma- quickest route to NDA

    • unmet need, or accelerated approval

  • Serendipity versus screening

    • Apriori, cannot predict activity

    • If we fail to have sarcoma patients, it is hard for us to convince sponsors to explore sarcoma as an indication


Ap23573 phase i

AP23573- Phase I

May 18 2004

Sep 15 2004


Ap23573 phase i1

AP23573 Phase I

34 yr old female with GIST Refractory to Gleevec, ET743 and others


Activity in phase i meaningful for some agents

Activity in Phase I Meaningful for Some Agents

Regulatory Success from phase I activity

  • Iressa: NSCLC activity phase I

    • colon intended as indication

    • Contrast Tarceva

  • Irinotecan: persistent SD in colorectal

  • Gemcitabine: pancreas


Integrated proliferation apoptosis targets

Integrated Proliferation/Apoptosis Targets

TRAIL

TNTC

TRM1

ETR2

CCI 779

AP23573

DR4/5

R115777

YM155

Oblimersen

Adapted from Johnstone et al. Cell. 2002.


Current phase i targets

Survivin

MFH

TRAIL R1

TRAIL R2

Durable SD

PDGFR

c-Met

Multi-targeted TKi

Integrins

mTOR

IGFR

Considerable literature

PARP

Kinesin 1 inhibitors

Aurora Kinase Inhibitors

Polo kinase inhibitors

C-myc

Current Phase I Targets


Opportunities for strategic collaborations

Opportunities for Strategic Collaborations

  • Sarcoma patients account for 10% or less of IDD phase I population (500 yr)

  • Serendipity or screening?

    • Can we increase “chance” to see activity

    • Known targets in sarcoma subtypes

    • Direct patients to studies

  • Early identification of activity, rapid dissemination to phase II through affiliation


Create a relationship

Create a Relationship

  • Activity seen in phase I (sarcoma pt)

  • Rapid access network of phase II sarcoma investigators to conduct study

    • Accrual remains a serious concern

    • Need to be “problem-free”

    • Quality of data remains the key


Referrals

Referrals

  • This is key

    • Early Screen / serendipity

    • 40% of our patients come from southern USA

    • Good performance status, adequate organ function

  • Help from patient advocates

    • Opportunities for patients looking for expt options


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