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New treatment option for Ovarian Cancer
Official title Phase 1b of Lurbinectedin in Combination With Weekly Paclitaxel and Bevacizumab in Platinum-resistant Ovarian Cancer
ClinicalTrials.gov ID: NCT05636111
What this study is testing
What is Paclitaxel?
Paclitaxel is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for ovarian cancer.
Also referred to as Taxol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To learn if adding lurbinectedin to the combination of paclitaxel and bevacizumab can help to control advanced cancer.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- will be assessed within 28 days of starting study treatment:
- Ability to provide signed informed consent in accordance with federal, local, and institutional guidelines.
- Age ≥ 18 years at time of study entry
- Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations...
- Histologically confirmed and documented ovarian, fallopian tube or peritoneal carcinoma: Patients with platinum refractory\ or platinum resistant\ \...
You likely can't join if
- Exclusion criteria will be assessed within 28 days of starting study treatment. Patients meeting any of the following exclusion criteria are not...
- Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤2 weeks prior to cycle 1 day 1.
- Use of an anti-cancer treatment drug or investigational drug during the last 28 days or 5 half-lives (whichever is shorter) prior to cycle 1 day 1. A...
- Patients with known or suspected conditions likely to increase gastrointestinal toxicity, such as inflammatory bowel disease, bowel obstruction...
- Patients who are pregnant or lactating.
- Major surgery \</= 28 days prior to cycle 1 day 1.
See the full eligibility criteria
Who can join
- will be assessed within 28 days of starting study treatment:
- Ability to provide signed informed consent in accordance with federal, local, and institutional guidelines.
- Age ≥ 18 years at time of study entry
- Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- Histologically confirmed and documented ovarian, fallopian tube or peritoneal carcinoma: Patients with platinum refractory\ or platinum resistant\ \ disease are allowed. Prior anti-VEGF targeted therapy (e.g...
- Platinum refractory is defined as progression during platinum-containing therapy or within 4 weeks of last dose.
- Platinum resistant is defined as relapse-free interval 1-6 months of a platinum-containing therapy
- Prior Therapy: Unlimited prior systemic therapies are allowed.
- ECOG performance status of 0-1 (Appendix A)
- Adequate normal organ and marrow function as defined below.
- Hemoglobin ≥9.0 g/dL.
- Absolute neutrophil count (ANC) \> 1500/mm3.
- Platelet count ≥100 x 109/L
- Serum bilirubin ≤1.5 x ULN. This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic...
- AST (SGOT)/ALT (SGPT) ≤2.5 x ULN unless liver metastases are present, in which case it must be ≤5x ULN.
- Measured creatinine clearance (CL) \>40 mL/min or Calculated creatinine CL\>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance...
- Evidence of post-menopausal status or negative urine or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an...
- Women \<50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and...
- Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception...
- Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses...
- Measurable disease by RECIST v1.1
What rules you out
- Exclusion criteria will be assessed within 28 days of starting study treatment. Patients meeting any of the following exclusion criteria are not eligible to enroll in this study.
- Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤2 weeks prior to cycle 1 day 1.
- Use of an anti-cancer treatment drug or investigational drug during the last 28 days or 5 half-lives (whichever is shorter) prior to cycle 1 day 1. A minimum of 10 days between termination of prior treatment and...
- Patients with known or suspected conditions likely to increase gastrointestinal toxicity, such as inflammatory bowel disease, bowel obstruction, history of bowel obstruction, or overt bowel involvement by tumor.
- Patients who are pregnant or lactating.
- Major surgery \</= 28 days prior to cycle 1 day 1.
- Unstable cardiovascular function:
- ECG abnormalities requiring treatment, or
- congestive heart failure (CHF) of NYHA Class ≥3, or
- myocardial infarction (MI) within 3 months.
- Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the study.
- Any known history or evidence of hepatitis A, B, or C infection; or known to be positive for HCV RNA or HBsAg (HBV surface antigen); Known to be HIV seropositive
- Grade \>2 peripheral neuropathy at baseline (within 14 days prior to cycle 1 day 1).
- Serious psychiatric or medical conditions that could interfere with treatment;
- Participation in an investigational anti-cancer study within 3 weeks prior to Cycle 1 Day 1
- Concurrent therapy with approved or investigational anticancer therapeutic other than steroids.
- Patients with coagulation problems and active bleeding within 4 weeks prior to C1D1 (peptic ulcer, epistaxis, spontaneous bleeding)
- Patients with symptomatic brain lesions
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
- History of hemoptysis (1/2 teaspoon of bright red blood per episode) within 1 month of study enrollment for any tumor type.
- Non-healing wound, ulcer or bone fracture.
- Known hypersensitivity to lurbinectedin, paclitaxel, bevacizumab or excipients.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.