West Cancer Center

MOLECULARLY TARGETED: Metastatic; >/=2nd line; P2P; "SIGNATURE CTKI258AUS26"

Molecular phase II study to link targeted therapy to patients with pathway activated tumors: Module 2 - Dovitinib for patients with tumor pathway activations inhibited by dovitinib including tumors with mutations or translocations of FGFR, PDGFR, VEGF, cKIT, FLT3, CSFR1, Trk, and RET

Title

Novartis CTKI258AUS26

Study Title

Site Link

NCT01831726

Malignancy

y- Advanced Cancer; non-squamous NSCLC (non-small cell lung), Melanoma, Ovarian, Thyroid, Multiple Myeloma, GIST (gastrointestinal stromal tumor), AML (acute myeloid leukemia)

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

>/=2nd line

Investigational Agent

Dovitinib (TKI258)

Drug Class

Angiogenesis inhibitor

Daruka Mahadevan, MD, PhD

Sponsor

Novartis Pharmaceuticals

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT01831726

Key Eligibility Criteria Details

Mutation or translocation of at least one of following genes:

FGFR 1/2/3, FLT3, cKIT,VEGFR 1/2, RET,
TrkA (NTRK1),PDGFRa/b,CSF-1R_
None of the following tumors:
Breast
RCC (kidney/renal)
Bladder
HCC (hepatocellular)
Endometrial
Squamous NSCLC
Heme malignancies (exceptFLT3 AML and MM)
At least one prior therapy for disease
ECOG 0-1
No brain mets
No anticoagulation

Objective

Primary- CBR: Secondary- ORR, PFS, OS, DoR, Safety

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Mutations or transolocations in: FGFR PDGFR VEGF cKIT FLT3 CSFR1 Trk RET

Dosing Frequency

Dovitinib 500mg oral 5 days on, 2 days off

Control Agents

N/A

Study Protocol

Randomized