OncoMatch/Clinical Trials/NCT04055649
ONC201 Plus Weekly Paclitaxel in Patients With Platinum Refractory or Resistant Ovarian Cancer
Is NCT04055649 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Akt/ERK Inhibitor ONC201 and Paclitaxel for malignant ovarian epithelial tumor.
Treatment: Akt/ERK Inhibitor ONC201 · Paclitaxel — This phase II trial studies the side effects of ONC201 and paclitaxel and how well they work in treating patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent), or that does not respond to treatment (refractory). ONC201 is the first in its class of drugs that antagonize some specific cell receptors on cancer cells, leading to their destruction. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ONC201 and paclitaxel may work better in treating patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer compared to paclitaxel alone.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy
Progressed within 6 months of completing at least 1 cycle of last platinum containing regimen. Patients with refractory disease (progression during platinum-containing therapy) are eligible.
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1,500/µL. Platelets ≥100,000/µL and hemoglobin > 8.0 gm/dL, transfusion allowed up to 1 week prior to maintain Hgb >8.
Kidney function
Calculated creatinine clearance (CrCl) ≥35 mL/min/1.73 mm2
Liver function
Bilirubin ≤ 1.5 x ULN; alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN. AP, AST and ALT ≤ 5 x ULN is acceptable if patient has known hepatic metastasis
Patients must have adequate (at baseline): Bone marrow function: ANC ≥1,500/µL. Platelets ≥100,000/µL and hemoglobin > 8.0 gm/dL, transfusion allowed up to 1 week prior to maintain Hgb >8. Renal function: Calculated creatinine clearance (CrCl) ≥35 mL/min/1.73 mm2. Hepatic function: Bilirubin ≤ 1.5 x ULN; AP, AST and ALT ≤ 3 x ULN. AP, AST and ALT ≤ 5 x ULN is acceptable if patient has known hepatic metastasis
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Barbara Ann Karmanos Cancer Institute · Detroit, Michigan
- Karmanos Cancer Institute at McLaren Flint · Flint, Michigan
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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