Clinical trial · Interventional
A Study of CRLX101(NLG207) in Combination With Weekly Paclitaxel in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
A Phase Ib/II Study of CRLX101 in Combination With Weekly Paclitaxel in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Company decision
Summary
Brief summary (as posted)
The purpose of this study is to estimate the maximum tolerated doses (MTD) of CRLX101 when administered in combination with weekly paclitaxel in women with recurrent or persistent, epithelial ovarian, fallopian tube or primary peritoneal cancer. Determine through pharmacokinetic evaluation(sometimes described as what the body does to a drug, refers to the movement of drug into, through and out of the body-the time and course of its absorption, bioavailability, distribution, metabolism, and excretion) whether or not the disposition of paclitaxel is affected by the concurrent administration of CRLX101.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CRLX101 | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Level 1
- description
- 12mg/kg CRLX101 and weekly paclitaxel administered by IV on days 1 and 15 of a 28 day cycle. Paclitaxel only is administered by IV on day 8.
- interventionNames
- Drug: CRLX101
- Drug: Paclitaxel
- type
- EXPERIMENTAL
- label
- Dose Level 2
- description
- 15mg/kg CRLX101 and weekly paclitaxel administered by IV on days 1 and 15 of a 28 day cycle. Paclitaxel only is administered by IV on day 8.
- interventionNames
- Drug: CRLX101
- Drug: Paclitaxel
Primary outcomes (2)
- measure
- 1. Number of Participants With Dose Limiting Toxicities (DLTs)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Histologic documentation of the original primary tumor is required via the pathology report. 2. Patient must have measurable disease or detectable (non-measurable) disease: Measurable disease will be defined by RECIST 1.1. 3. Patients must have adequate bone marrow, renal, hepatic, and neurologic functions 4. Patients should be free of active infection requiring parenteral antibiotics. 5. Any other prior therapy directed at the malignant tumor, including chemotherapy, bevacizumab or other biologic or targeted agents and immunologic agents, must be discontinued at least 21 days (three weeks) prior to registration. 6. Any prior radiation therapy must be discontinued at least four weeks prior to registration. 7. Major surgery within 28 days (four weeks) prior to registration. 8. Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease. 9. Patients must have a GOG performance status of 0 or 1. 10. Patients who will be enrolled under protocol amendment # 2 must have previously received bevacizumab, either discontinued due to intolerability, or progressed after at least 2 cycles of bevacizumab Exclusion Criteria: 1. Patients who have had previous treatment with: * CRLX101 or with any topoisomerase I therapy; * Weekly paclitaxel for recurrent or persistent disease. 2. Patients with a history of other invasive malignancies, with the exception of non-melanoma skin, are excluded if: * There is any evidence of other malignancy being present within the last three years; * Previous cancer treatment contraindicates this protocol therapy. 3. Patients with known active hepatitis or HIV. 4. Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first dose of study drug. 5. Patients with clinically significant cardiovascular disease. 6. Patients with serous non-healing wound, ulcer, or bone fracture. 7. Patients with active bleeding or pathologic conditions that carry high risk of bleeding 8. Patients with clinical symptoms or signs of gastrointestinal obstruction and who require parenteral hydration and/or nutrition. 9. Patients with active infection requiring parenteral antibiotics.
References
Publications (1)
- DERIVEDDuska LR, Krasner CN, O'Malley DM, Hays JL, Modesitt SC, Mathews CA, Moore KN, Thaker PH, Miller A, Purdy C, Zamboni WC, Lucas AT, Supko JG, Schilder RJ. A phase Ib/II and pharmacokinetic study of EP0057 (formerly CRLX101) in combination with weekly paclitaxel in patients with recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Gynecol Oncol. 2021 Mar;160(3):688-695. doi: 10.1016/j.ygyno.2020.12.025. Epub 2020 Dec 31. PMID 33390325