NCT02562443: INSPIRE

Controlled Study of Rigosertib Versus Physician's Choice of Treatment in MDS Patients After Failure of an HMA

Terminated Phase 3 Last updated 26 September 2022

What this trial tests

Phase 3 trial testing rigosertib in Myelodysplastic Syndrome in 372 participants. Terminated before completion.

Timeline

2 December 2015

Primary endpoint
26 July 2020

26 July 2021

Quick facts

Lead sponsor	Traws Pharma, Inc.
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	372
Start date	2 December 2015
Primary completion	26 July 2020
Estimated completion	26 July 2021
Sites	158 locations across Italy, Japan, Ireland, Poland, Croatia, Russia, Belgium, Sweden

Drugs / interventions tested

• rigosertib — full drug profile →
• Any approved or standard-of-care therapy — full drug profile →
• best supportive care (BSC) — full drug profile →
• best supportive care (BSC) — full drug profile →

Conditions studied

• Myelodysplastic Syndrome — all drugs for Myelodysplastic Syndrome →
• MDS — all drugs for MDS →
• Refractory Anemia With Excess Blasts — all drugs for Refractory Anemia With Excess Blasts →
• RAEB — all drugs for RAEB →

Sponsor

Traws Pharma, Inc. — full company profile →

Who can join

Adults 18 to 81, any sex, with Myelodysplastic Syndrome or MDS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study's primary objective \[in a population of patients with MDS after failure of treatment with azacitidine (AZA) or decitabine (DAC)\], is to compare the overall survival (OS) of patients in the rigosertib group vs the Physician's Choice group, in all patients and in a subgroup of patients with IPSS-R very high risk.

Publications & conference data

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

1. Targeting PI3K in cancer: mechanisms and advances in clinical trials.
   Yang J, Nie J, Ma X, Wei Y, et al · · 2019 · cited 1142× · PMID 30782187 · DOI 10.1186/s12943-019-0954-x
2. Hypomethylating agents (HMA) for the treatment of acute myeloid leukemia and myelodysplastic syndromes: mechanisms of resistance and novel HMA-based therapies.
   Stomper J, Rotondo JC, Greve G, Lübbert M. · · 2021 · cited 163× · PMID 33958699 · DOI 10.1038/s41375-021-01218-0
3. The two sides of chromosomal instability: drivers and brakes in cancer.
   Hosea R, Hillary S, Naqvi S, Wu S, et al · · 2024 · cited 102× · PMID 38553459 · DOI 10.1038/s41392-024-01767-7
4. Myelodysplastic syndromes current treatment algorithm 2018.
   Steensma DP. · · 2018 · cited 91× · PMID 29795386 · DOI 10.1038/s41408-018-0085-4
5. Current challenges and unmet medical needs in myelodysplastic syndromes.
   Platzbecker U, Kubasch AS, Homer-Bouthiette C, Prebet T. · · 2021 · cited 67× · PMID 34045662 · DOI 10.1038/s41375-021-01265-7
6. Second-Generation Antimitotics in Cancer Clinical Trials.
   Novais P, Silva PMA, Amorim I, Bousbaa H. · · 2021 · cited 37× · PMID 34371703 · DOI 10.3390/pharmaceutics13071011
7. Drug Screening and Drug Repositioning as Promising Therapeutic Approaches for Spinal Muscular Atrophy Treatment.
   Menduti G, Rasà DM, Stanga S, Boido M. · · 2020 · cited 27× · PMID 33281605 · DOI 10.3389/fphar.2020.592234
8. Emerging treatment options for patients with high-risk myelodysplastic syndrome.
   Bewersdorf JP, Carraway H, Prebet T. · · 2020 · cited 24× · PMID 33240476 · DOI 10.1177/2040620720955006