Clinical trial · Interventional
SARC023: Ganetespib and Sirolimus in Patients With MPNST (Malignant Peripheral Nerve Sheath Tumors)
A Phase I/II Trial of Ganetespib in Combination With the mTOR Inhibitor Sirolimus for Patients With Recurrent or Refractory Sarcomas Including Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase 1: To assess the safety, tolerability, and maximum tolerated dose (MTD)/ recommended dose of ganetespib when administered in combination with sirolimus in patients with refractory or relapsed sarcomas including unresectable or metastatic sporadic or neurofibromatosis type 1 (NF1) associated MPNST. Phase I enrollment has been closed. Phase 2: To determine the clinical benefit of ganetespib in combination with sirolimus for patients with unresectable or metastatic sporadic or NF1 associated MPNST.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Peripheral Nerve Sheath Tumors (MPNST) | Malignant Peripheral Nerve Sheath Tumor | ONTOLOGY_EXACT | 0.85 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ganetespib | Drug | Ganetespib | ALIAS |
| Sirolimus | Drug | Sirolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ganetespib / sirolimus
- description
- 28-day cycles of ganetespib + sirolimus
- interventionNames
- Drug: ganetespib
- Drug: Sirolimus
Primary outcomes (2)
- measure
- Number of Dose Limiting Toxicities of Ganetespib When Administered in Combination With Sirolimus.
- timeFrame
- Toxicities will be evaluated over the first treatment cycle (each cycle=28 days)
- description
- To assess the safety, tolerability, and maximum tolerated/ recommended dose of ganetespib when administered in combination with sirolimus in patients with refractory sarcomas or unresectable or metastatic sporadic or neurofibromatosis type 1 (NF1) associated MPNST. Toxicities observed during the first cycle will be used to define the MTD/Recommended dose. Toxicity will be graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. DLT will be defined as any of the following events that are possibly, probably, or definitely attributable to ganetespib or sirolimus. The DLT observation period for the purposes of dose escalation will be the first cycle of therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Patients ≥ 16 years old * Patients with unresectable or metastatic histologically confirmed sporadic or NF1 associated high grade MPNST * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 * Patients must have at least 1 measurable tumor * Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy (toxicity \< grade 2) * Must be able to swallow whole pills * Adequate organ function * Normal fasting cholesterol and triglycerides * May be on cholesterol medications Exclusion Criteria: * Patients receiving current treatment with corticosteroids or another immunosuppressive. Topical or inhaled corticosteroids are allowed. * Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases * Symptomatic congestive heart failure * Severely impaired lung function * Significant vascular disease * Uncontrolled diabetes * Active (acute or chronic) or uncontrolled severe infections hepatitis * Impairment of gastrointestinal function * Patients with an active, bleeding diathesis or significant coagulopathy * Use of cytochrome P450 isoenzyme 3A4 (CYP3A4)/ CYP2C19 substrates
References
Publications (1)
- DERIVEDKim A, Lu Y, Okuno SH, Reinke D, Maertens O, Perentesis J, Basu M, Wolters PL, De Raedt T, Chawla S, Chugh R, Van Tine BA, O'Sullivan G, Chen A, Cichowski K, Widemann BC. Targeting Refractory Sarcomas and Malignant Peripheral Nerve Sheath Tumors in a Phase I/II Study of Sirolimus in Combination with Ganetespib (SARC023). Sarcoma. 2020 Jan 30;2020:5784876. doi: 10.1155/2020/5784876. eCollection 2020. PMID 32089640