Navigate the Synta Pharma SNTA Research Notes Pages
- Introduction (valuation, financials, outlooks, catalysts)
- Ganetespib - Background (HSP90, basic drug info, regulatory strategies and business development)
- Ganetespib - HSP90 inhibitor safety and toxicity (info on liver and ocular toxicities associated with this class of drugs)
- Ganetespib - NSCLC (lead programs in lung cancer including ALK+ group and combo w/ docetaxel)
- Ganetespib - Clinical Trials (complete list of trials in other indications and links to data presentations)
- Elesclomol & Pipeline (information about other drug candidates in the SNTA pipeline)
- HSP90 Inhibitors - learn more about targeting heat shock protein 90 and all inhibitors in development
Completed, ongoing, or planned company-sponsored trials
These trials are funded and operated by Synta Pharma. Be sure to check out the clinical trials in the flagship indication of non-small cell lung cancer here.
Last updated May 8, 2012.
Last updated May 8, 2012.
- Phase 1 solid tumors once per week dosing (NCT00687934; 5/2012 ongoing but not recruiting). 35 pts - enrollment stopped July 2011, 7-259 mg/m2
- Phase 1 solid tumors 2x per week dosing (NCT00688116; 5/2012 active and recruiting; target 45 pts). --- Interim data presented 6/2010 at ASCO: 29 pts at 2-25 mg/m2, single DLT at 10 mg/m2 was elevated LFTs, still escalating up to 50 mg at least).
- Phase 1 hematological malignancies once per week dosing (NCT00964873; 5/2012 ongoing but not recruiting; target 40 pts).
--- 6/2011 at ASCO presented final results (click for PR): Safe and well tolerated up to 144 mg/m2 dose, no MTD yet, still ongoing. 54 patients enrolled total (36 at doses of 2-50 mg/m2, 11 at 100-120 mg/m2, and 7 at 144 mg/m2), 13 pts discontinue prior to 8 week evaluation, therefore 41 pts evaluable at this time- observed 2 single-agent PRs (triple negative breast cancer, melanoma) and 12 SD.
- Phase 1 hematological malignancies twice per week dosing (NCT00858572; 5/2012 active but not recruiting; target 60 pts - enrollment stopped March 2012).
- Phase 1/2 combo w/ docetaxel in solid tumors (NCT01183364; 5/2012 active and recruiting; target 27 pts). Weekly 2 out of 3 weeks cycle. Includes lung, prostate, breast, others. First patient treated 8/2010.
- Phase 2 open label in GIST (NCT01039519; 5/2012 ongoing but not recruiting). SNTA-sponsored, weekly dosing. Initiated 12/2009, target 55 pts, closed to enrollment 3/2012. Metastatic or unresectable tumors after gleevec and sutent failure. 3q2010 10q: stage 1 done and passed criteria to advance to stage 2. Click here for more info on the rationale of usin HSP90 inhibitors in GIST
- Phase 2 in Her2+ and triple negative breast cancer. Not yet initiated.
---9/2011 presented phase 1 combo data at EMCC (click here for complete abstract - click here for PR). Tested 3 doses: 60 mg/m2 docetaxel + 150 mg/m2 ganetespib; 75 mg/m2 docetaxel + 150 mg/m2 gan; 75 mg/m2 docetaxel + 200 mg/m2 gan. Highest dose has 2/4 patients with dose limiting toxicity, so expanded middle dose and selected this for phase 2b trial. 10 total patients evaluable (median 4 cycles, 6 still on study), 7 of which had SD at 6 weeks, 4 at 12 weeks, and 1 to 18 weeks. One confirmed PR.
Ongoing and planned Phase 2, open-label, single-agent investigator-sponsored trials (ISTs)
These trials are not funded or conducted by SNTA, but are initiated by medical researchers, institutes, etc seeking to explore single-agent ganetespib efficacy in various tumor types.
Last updated May 8, 2012.
Last updated May 8, 2012.
- Colorectal cancer (NCT01111838; 10/2011 active but no longer recruiting). Investigator-sponsored, weekly dosing. Initiated 2q2010, target 33 pts
- Advanced esophagogastric cancer (NCT01167114; 10/2011 active and recruiting). Investigator-sponsored, weekly dosing. Initiated 2q2010, target 40 previously treated pts
- Small-cell lung cancer (NCT01173523; 10/2011 active and recruiting). Investigator-sponsored, weekly dosing. Initiated 3q2010, target 52 pts.
- Metastatic ocular melanoma (NCT01200238; 10/2011 active and recruiting). Investigator-sponsored, weekly dosing. Initiated 3q2010, target 30 pts.
- Second-line metastatic pancreatic cancer (NCT01227018; 10/2011 active and recruiting). Investigator-sponsored, weekly dosing. Initiated 4q2010, target 43 pts.
- Metastatic hormone refractory prostate cancer (HRPC) (NCT01270880; 10/2011 active and recruiting). Investigator-sponsored, weekly dosing. Initiated 4q2010, target 51 pts previously treated with docetaxel
- Metastatic breast cancer (NCT01273896; 10/2011 active but no longer recruiting). Investigator-sponsored, weekly dosing. Initiated 4q2010, target 40 pts.
- ganetespib +/- dutasteride in HRPC (NCT01368003; 5/2012 - suspended in 2/2012 to revise and allow other sites to participate). Primarily a biomarker study of androgen receptor expression and its target genes, also measuring response rate, PFS, OS. Started 4/2011, targeting 30 pts.
Completed, ongoing, or planned ISTs in combination with other agents
- Phase 1/2 open label in liver cancer (HCC). Investigator sponsored, initiated 3q2010. (As of 10/2011 no info found on clinicaltrials.gov)
- Phase 1 in relapsed/refractory multiple myeloma (MM) in combo w/ bortezomib (VELCADE). (NCT01485835; active and recruiting as of May 2012). Initiated January 2012. MMRF support up to $1m announced January 2011 with plans to initiate 2h-2011. Classic 3+3 design to determine MTD of combination.
- Phase 1 in rectal cancer in combo with radiation and capecitabine (NCT01554969, not yet recruiting as of May 2012). Targeting 24 pts.
- Phase 1/2 in malignant pleural mesothelioma in combo with pemetrexed-cisplatin (NCT01590160; not yet recruiting patients as of May 2012). Listed as starting in September 2012. Doses of 100, 150, 200 mg/m2 ganetespib.
- Phase 2 trial in HR+ breast cancer combo with fulvestrant (FASLODEX) (NCT01560416; 5/2012 not yet recruiting patients). Randomized, open label at Dana Farber. Hormone receptor positive metastatic breast cancer. Target 71 pts, allows crossover after progression. PFS is primary endpoint.