2026-07-24
minor
Study Status, Contacts/Locations v22
Trial sites expanded: 152 → 164 locations
2026-07-01
minor
Study Status, Contacts/Locations v21
Trial sites expanded: 146 → 152 locations
2026-05-20
minor
Study Status, Contacts/Locations v20
Trial sites expanded: 129 → 146 locations
2026-05-11
minor
Study Status, Contacts/Locations v19
Trial sites expanded: 120 → 129 locations
2026-01-08
minor
Study Identification, Study Status, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v18
Primary completion date2027-12-31→2028-02-29
Completion date2029-12-31→2030-04-30
Enrollment target710→860
InterventionsGemcitabine (Drug), PLD (Drug), Paclitaxel (Drug), R-DXd (Drug), Topotecan (Drug)→PLD (Drug), Paclitaxel (Drug), R-DXd (Drug), Topotecan (Drug)
Eligibility criteria-2,561 characters
[...] d OVC, primary peritoneal cancer, or fallopian tube cancer.
For Phase 2 (Part A) Participants must have at least 1 lesion, not previously irr [...] previously irradiated, performed within 6 months of consent, and performed after treatment with their most recent cancer therapy regimen.
For Phase 2 (Part A): Has received at least 1 but no more than 3 prior systemic lines of anticancer therapy.
For Phase 3 (Part B): Has received at least 1 but no more than 4 prior systemic lines of anticancer therapy:
Neoadjuvant +/-adjuvant considered 1 line of therapy.
Main [...] the date of the last dose of platinum If a s [...]
Secondary endpoints16 to 21 entries
Progression-free Survival (PFS) Based on BICR and Investigator Assessment
Change from Baseline in Abdominal/gastrointestinal (GI) Symptoms (Part AB)
Change infrom ScoreBaseline in theFatigue/Pain Quality of LifeSymptoms (QoLPart B)
Time Questionnaireto Deterioration in Fatigue/Pain Symptoms (Part B)
Time to Deterioration in GI Symptoms (Part B)
Time to Deterioration in Disease Impacts (Part B)
Change from Baseline in Disease Impacts (Part B)
Primary endpoints3 to 2 entries
Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Assessment (Part B)
Study sitesdetails revised at 47 of 120 sites
Show 17 earlier versions
2025-11-26
minor
Study Status, Contacts/Locations v17
2025-09-12
minor
Study Status, Contacts/Locations v16
2025-08-06
minor
Study Status, Contacts/Locations v15
2025-07-08
notable
Active, Not Recruiting→Recruiting Study Status, Study Description, Study Design, Outcome Measures, Eligibility, Contacts/Locations v14
Trial statusActive, Not Recruiting→Recruiting
Enrollment target650→710
Study sites82→108
Eligibility criteria-74 characters
[...] nterval corrected with Fridericia's formula interval >470 ms (average of triplicate determinations).
Diagnosed or suspected long QT syndrome or known family hi [...] Pointes.
The participant has bradycardia of less than 50 bpm (as determined by central reading), unless the subject has a pacemaker.
History of second- or [...]
Secondary endpoints16 entries, revised
Percentage of Participants With Objective Response Rate (ORR) Based on Investigator Assessment
Primary endpoints3 entries, revised
Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Assessment (Part A)
Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Assessment (Part B)
2025-03-25
minor
Study Status v13
Re-verified, no change to tracked fields
2025-01-23
minor
Study Status, Contacts/Locations v12
2024-11-18
minor
Study Status, Contacts/Locations v11
2024-10-21
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v10
Trial statusRecruiting→Active, Not Recruiting
Study sites78 entries, revised
University'Mount ofSinai MiamiComprehensive MillerCancer School of MedicineCenter
2024-10-14
minor
Study Status, Contacts/Locations v9
2024-09-18
minor
Study Status, Contacts/Locations v8
2024-08-22
minor
Study Status, Contacts/Locations v7
2024-06-26
minor
Study Status, Contacts/Locations v6
2024-05-20
minor
Study Status, Contacts/Locations v5
2024-04-10
minor
Study Identification, Study Status v4
Study titlerevised
A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High Grade-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
2024-03-22
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-02-29→confirmed 2024-02-27
Study sites0→3
2024-03-05
minor
Study Status, Eligibility v2
Eligibility criteria+7,443 characters
[...] psy sample not required for the Phase 3 part of the study).
Fresh pretreatment biopsy may be waived for subjects who consent to provide an archival tumor tissue sample from a lesion not previously irradiated, performed within 6 months of consent, and performed after treatment with their most recent cancer therapy regimen.
Has received at least 1 but no more than 3 prior systemic lines of anticancer therapy:
Neoadjuvant +/-adjuvant considered 1 line of therapy.
Maintenance therapy (eg, bevacizumab, poly-ADP ribose polymerase [PARP] inhibitors) will be considered part of the preceding line of th [...] [...]
2023-12-07
minor
Study Status, Outcome Measures v1
Secondary endpoints16 entries, revised
Cadherin-6 (CHD6CDH6) protein expression in tumor tissue as determined by immunochemistry assay and correlation with ORR, DoR, PFS and OS