A Phase 2 Open-Label Study Evaluating the Efficacy and Safety of Telatinib in Combination with Chemotherapy as First-line Therapy in Subjects with Advanced Gastric CancerEstudio de fase 2, abierto, de evaluación de la eficacia y la seguridad de telatinib en combinación con quimioterapia como tratamiento de primera línea en pacientes con cáncer gástrico avanzado

Start Date17 Jun 2009

Sponsor / Collaborator

ACT Biotech, Inc.

NCT00952497 / CompletedPhase 2

A Phase 2 Open-Label Study Evaluating the Efficacy and Safety of Telatinib in Combination With Chemotherapy as First-Line Therapy in Subjects With Advanced Gastric Cancer

The objectives of this study are to evaluate the anti-tumor activity, safety, and tolerability of telatinib when used in combination with chemotherapy (capecitabine and cisplatin) as first-line therapy in subjects with advanced gastric cancer. The primary objective is to assess progression free survival (PFS) in subjects receiving telatinib in combination with chemotherapy (capecitabine and cisplatin). The secondary objectives are to assess overall survival, overall response rate, safety and tolerability, pharmacokinetics and biomarkers.

Start Date01 Jun 2009

Sponsor / Collaborator

ACT Biotech, Inc.

100 Clinical Results associated with ACT Biotech, Inc.

0 Patents (Medical) associated with ACT Biotech, Inc.

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20 May 2012·Journal of Clinical Oncology

Response rates to single-agent carfilzomib in patients refractory or intolerant to both bortezomib and immunomodulators in trial PX-171-003-A1.

Author: Chang, Yu-Lin ; Kukreti, Vishal ; Reu, Frederic J. ; Siegel, David Samuel DiCapua ; Vij, Ravi ; Kunkel, Lori A. ; Jakubowiak, Andrzej J. ; Chanan-Khan, Asher Alban Akmal ; Stewart, A. Keith ; Singhal, Seema ; Rajangam, Kanya ; Alsina, Melissa ; Lonial, Sagar ; Martin, Thomas ; Somlo, George ; Jagannath, Sundar ; Bahlis, Nizar J. ; Orlowski, Robert Z. ; Buadi, Francis ; Wang, Michael

8035 Background: Patients (pts) with relapsed and refractory multiple myeloma (RR MM) who are refractory or intolerant to both bortezomib (BTZ) and immunomodulators (IMiDs; thalidomide [Thal] or lenalidomide [Len]) (ie, “double-refractory/intolerant”), have few therapeutic options and a poor prognosis. Carfilzomib (CFZ), a next generation proteasome inhibitor (PI), has shown durable single-agent activity in clinical studies including 003-A1, an open-label, single-arm phase 2b trial in RR MM. The present analysis describes clinical activity in pts from 003-A1 with double-refractory/intolerant disease and in other groups of clinical interest including pts with disease refractory to all 5 approved classes of anti-MM tx (alkylators, anthracyclines, corticosteroids, IMiDs, and PIs) in clinical use (“refractory to all approved tx”). Methods: Pts from 003-A1 with double-refractory/intolerant disease were analyzed, as were pts with disease refractory to all approved tx. CFZ was given on days 1, 2, 8, 9, 15, 16 of 28-day cycles (C), (20 mg/m2 in C1; 27 mg/m2 in C2–12). Primary endpoint was overall response rate (ORR). Secondary endpoints included duration of response (DOR), overall survival, and safety. Results: The study ORR was 22.9% with median DOR of 7.8 mo (N=266). 228 pts (86%) with double-refractory/intolerant disease had ORRs of 20.6% and a median DOR of 7.4 mo. Conclusions: Single-agent CFZ demonstrated clinically meaningful, durable responses in pts with double-refractory/intolerant MM or disease refractory to all 5 approved classes of tx. The ORRs across groups of clinical interest were generally consistent with results for the entire study population. These results are notable for a next-generation PI and demonstrate the activity of single-agent CFZ in pts with advanced stage MM. [Table: see text]

12 Nov 2011·Molecular Cancer Therapeutics

Abstract A6: Association of clinical outcomes and the change in circulating soluble VEGF receptor 2 (VEGFR2) levels in advanced gastric cancer patients treated with telatinib (Tel), capecitabine (X), and cislatin (P).

Author: Kunkel, Lori A. ; Ajani, Jaffer ; Fattaey, Ali ; Baker, Jackie ; Cruikshank, Scott

AbstractBackground: Serum VEGFA concentrations and association with metastasic disease/and or poor outcome has been well documented in gastric cancer (GC) patients (pts). However, VEGFA has not been a useful predictor for outcome of treatment with VEGF pathway inhibitors. The soluble form of the VEGF receptor 2 (sVEGFR2) neutralizes circulating VEGF and functions as a negative feedback mechanism to enable partial inhibition of angiogenesis. Reduction in circulating sVEGFR2 levels has been shown upon treatment with multiple small molecule VEGFR inhibitors. Tel is a potent, oral and selective inhibitor of VEGFR 1, 2 and 3 and PDGF receptors. We investigated if marked decrease in the concentration of sVEGFR2 from baseline in response to Tel treatment were associated with lower risk of progression and death compared to pts with smaller decreases or no decrease from baseline.Methods: TEL0805, a phase 2 study, administered Tel with X and P (TEL-XP) as first-line treatment for advanced GC pts. Tel was administered at 900 mg bid beginning day (d)-7 (lead-in for PK/PD analysis) continuously until progression, X was administered d1–14, and P d1 of each 21 day cycle. Serum samples for sVEGR2 analysis were collected on d-7 (baseline) and d1 prior to treatment of the first and every other cycle. Pts whose maximum percentage decrease from baseline was >33% were considered to have “larger” decreases in sVEGFR2. Pts whose maximum percentage decrease from baseline was <33% were considered to have “smaller” decreases, this group included pts with sVEGFR2 levels unchanged or increased from baseline.Results: Twenty-eight pts (25 metastatic, 3 stage III) had sVEGFR2 levels available for analysis. The median baseline sVEGR2 levels were 6,780 pg/mL (range 3,750 to 9,100). Treatment with Tel alone demonstrated onset of reduction of sVEGFR2 by d 7 of the first cycle. Reductions were achieved regardless of tumor histology or disease location. The median of the distribution corresponds to a maximum decrease from baseline of 25%. The duration of OS and PFS were both significantly longer for pts with ≥33% in sVEGFR2 relative to pts with <33%. Median PFS was 4.7 vs. 11.6 months (mths) for pts with smaller versus larger decreases in sVEGFR2 (hazard ratio 0.19; 95% CI: 0.05 to 0.68; p=0.01 by log-rank test). Similarly, median OS was 7.6 mths for pts with smaller decreases in sVEGFR2 and was not reached for pts with larger decreases (hazard ratio 0.23; 95% CI: 0.05 to 1.03; P=0.04 by log-rank test). Follow-up for surviving pts with larger decreases in sVEGFR2 ranges from 9 to 14 mths.Conclusions: In GC pts treated with the TEL-XP regimen, larger percentage decreases in the concentration of sVEGFR2 from baseline were associated with lower risk of progression and death compared to pts with smaller decreases or no decrease from baseline. Further study of sVEGR2 levels as a predictor of response to TEL-XP will be explored in a randomized setting.Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics; 2011 Nov 12-16; San Francisco, CA. Philadelphia (PA): AACR; Mol Cancer Ther 2011;10(11 Suppl):Abstract nr A6.

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Drug(Targets)	Indications	Global Highest Phase

EDP-317 ( FGFRs x VEGFR2 )	Neoplasms More	Pending
Telatinib ( PDGFRβ x VEGFR2 x VEGFR3 x c-Kit )	Advanced gastric carcinoma More	Pending
ACTB-1011 ( ABL x VEGFR x c-Kit )	Neoplasms More	Pending

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