Phase 1b of Lurbinectedin in Combination With Weekly Paclitaxel and Bevacizumab in Platinum-resistant Ovarian Cancer
2 other identifiers
interventional
34
1 country
1
Brief Summary
To learn if adding lurbinectedin to the combination of paclitaxel and bevacizumab can help to control advanced cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 ovarian-cancer
Started Jul 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2022
CompletedFirst Posted
Study publicly available on registry
December 5, 2022
CompletedStudy Start
First participant enrolled
July 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
January 22, 2026
January 1, 2026
3.5 years
November 23, 2022
January 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
through study completion; an average of 1 year.
Study Arms (1)
Dose Escalation and Dose Expansion
EXPERIMENTALPariticipants will be assigned to a dose level of combined paclitaxel, bevacizumab, and lurbinectedin
Interventions
Given by (IV) vein
Eligibility Criteria
You may qualify if:
- 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. bevacizumab, VEGF TKI's) is allowed.
- 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 pathology), who will be allowed only in consultation with their physician.
- 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:
- +6 more criteria
You may not qualify if:
- 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 administration of study treatment is required.
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jazz Pharmaceuticalscollaborator
- M.D. Anderson Cancer Centerlead
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shannon Westin, MD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2022
First Posted
December 5, 2022
Study Start
July 12, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
January 22, 2026
Record last verified: 2026-01