NCT01006252 (SUMMIT-1) is a Phase 3 clinical trial of Tasisulam-sodium in Melanoma, sponsored by Eli Lilly and Company.

Who is sponsoring NCT01006252?

NCT01006252 is sponsored by Eli Lilly and Company.

What drugs are being tested in NCT01006252?

Interventions in NCT01006252: Tasisulam-sodium, Paclitaxel.

Is NCT01006252 still recruiting?

NCT01006252 is currently terminated. Last updated 18 June 2018.

Are results published for NCT01006252?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-06-18 · How we verify

NCT01006252: SUMMIT-1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized Phase 3 Study of Tasisulam-sodium Administered as an Intravenous Infusion on Day 1 of a 28-Day Cycle Versus Paclitaxel as Second-line Treatment in Patients With Metastatic Melanoma

Terminated Phase 3 Results posted Last updated 18 June 2018

What this trial tests

Phase 3 trial testing Tasisulam-sodium in Melanoma in 336 participants. Terminated before completion.

Timeline

1 December 2009

Primary endpoint
1 March 2011

1 March 2011

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	336
Start date	1 December 2009
Primary completion	1 March 2011
Estimated completion	1 March 2011
Sites	122 locations across United States, Australia, Austria, Belgium, Canada, Finland, France, Germany

Drugs / interventions tested

Tasisulam-sodium
Paclitaxel — full drug profile →

Conditions studied

Melanoma — all drugs for Melanoma →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

18 and older, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Overall Survival (OS)
Time frame: Randomization to date of death from any cause (assessed at every cycle and every 60 days following treatment discontinuation) up to 14.32 months
OS is duration from enrollment to death; OS censored for participants who were alive at last contact.

Sponsor's own description

The primary purpose of this study was to see how tasisulam-sodium affected metastatic melanoma when compared against paclitaxel as measured by overall survival.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

RNA-binding protein 39: a promising therapeutic target for cancer.
Xu C, Chen X, Zhang X, Zhao D, et al · · 2021 · cited 57× · PMID 34389703 · DOI 10.1038/s41420-021-00598-7
Transforming of the Tumor Microenvironment: Implications for TGF-<i>β</i> Inhibition in the Context of Immune-Checkpoint Therapy.
Löffek S. · · 2018 · cited 36× · PMID 30631358 · DOI 10.1155/2018/9732939
Targeting RNA splicing modulation: new perspectives for anticancer strategy?
Lv X, Sun X, Gao Y, Song X, et al · · 2025 · cited 18× · PMID 39885614 · DOI 10.1186/s13046-025-03279-w
Alternative splicing: from tumorigenesis to neoantigen-mediated cancer immunotherapy.
Lv YH, He YC, Dai XY, Yang XJ, et al · · 2025 · PMID 41316436 · DOI 10.1186/s40364-025-00877-w

Verify or expand the search:

Other recruiting trials for Melanoma

Currently open trials in the same condition.

NCT07524114 — Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception · recruiting
NCT07224425 — A Study in People With Advanced Cancer (Solid Tumours) to Test Different Doses of BI 3810944 and to Find Out Whether it · Phase 1 · recruiting
NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr · Phase 2 · recruiting
NCT07225036 — Promoting Immunotherapy Efficacy With Low-Dose Liver RT · NA · recruiting
NCT07379138 — Studying Quality of Life Inclusive of Mental Health and Cognitive Behavioral Therapy for Cancer Distress for the Improve · NA · recruiting

Other Eli Lilly and Company trials

Trials by the same sponsor.

NCT07533006 — A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss) · Phase 2 · not yet recruiting
NCT07533019 — A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo · Phase 2 · not yet recruiting
NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants · Phase 1 · completed
NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants · Phase 1 · completed
NCT07030127 — A Study of LY3985863 in Healthy Participants · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01006252 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 18 June 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01006252.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing