Actively Recruiting

Phase 1
Age: 18Years +
FEMALE
NCT05636111

Phase 1b of Lurbinectedin in Combination With Weekly Paclitaxel and Bevacizumab in Platinum-resistant Ovarian Cancer

Led by M.D. Anderson Cancer Center · Updated on 2026-01-22

34

Participants Needed

1

Research Sites

181 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

J

Jazz Pharmaceuticals

Collaborating Sponsor

AI-Summary

What this Trial Is About

To learn if adding lurbinectedin to the combination of paclitaxel and bevacizumab can help to control advanced cancer.

CONDITIONS

Official Title

Phase 1b of Lurbinectedin in Combination With Weekly Paclitaxel and Bevacizumab in Platinum-resistant Ovarian Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to provide signed informed consent
  • Age 18 years or older at study entry
  • Willing and able to follow study treatment, visits, and exams
  • Histologically confirmed ovarian, fallopian tube, or peritoneal carcinoma with platinum refractory or resistant disease
  • Prior anti-VEGF therapies allowed
  • Unlimited prior systemic therapies allowed
  • ECOG performance status 0 or 1
  • Adequate organ and marrow function: hemoglobin 6590 g/dL, ANC >1500/mm3, platelet count 65100 x 10^9/L, bilirubin 651.5 x ULN (exceptions for Gilbert's syndrome), AST/ALT 652.5 x ULN (or 655x ULN if liver metastases present), creatinine clearance >40 mL/min
  • Post-menopausal status or negative pregnancy test for pre-menopausal women with specific hormone or surgical criteria
  • Female patients of child-bearing potential must use dual contraception methods during and 3 months after study
  • Measurable disease by RECIST v1.1
Not Eligible

You will not qualify if you...

  • Radiation, chemotherapy, immunotherapy, or other anticancer therapy within 2 weeks prior to starting study treatment
  • Use of investigational anticancer drugs within 28 days or 5 half-lives prior to study start
  • Conditions increasing gastrointestinal toxicity risk (e.g., inflammatory bowel disease, bowel obstruction)
  • Pregnant or lactating women
  • Major surgery within 28 days prior to study treatment
  • Unstable cardiovascular function, including ECG abnormalities needing treatment, NYHA Class 653 heart failure, or recent myocardial infarction
  • Uncontrolled infections requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior
  • Known hepatitis A, B, or C infections, or HIV positive status
  • Grade >2 peripheral neuropathy at baseline
  • Serious psychiatric or medical conditions interfering with treatment
  • Participation in other investigational anticancer studies within 3 weeks prior
  • Concurrent anticancer therapy other than steroids
  • Coagulation problems or active bleeding within 4 weeks prior
  • Symptomatic brain lesions
  • Evidence of bleeding diathesis or significant coagulopathy without therapeutic anticoagulation
  • Recent hemoptysis within 1 month
  • Non-healing wounds, ulcers, or bone fractures
  • Known allergies to lurbinectedin, paclitaxel, bevacizumab, or their components

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

S

Shannon Westin, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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