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A Phase 3, Randomized, Open-Label Study of Combination Therapy with Avutometinib plus Defactinib Versus Investigator’s Choice of Treatment in Patients with Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) (RAMP301)
EU CTIS ID: 2023-508204-38-00
What this study is testing
To compare the progression-free survival (PFS) of the combination of avutometinib plus defactinib vs Investigator’s Choice of Treatment (ICT) in patients with recurrent LGSOC.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Adequately recovered (Grade ≤ 1 by CTCAE v 5.0) from any toxicities related to prior treatments except alopecia or hypothyroidism.
- For patients with reproductive potential, a negative serum pregnancy test (β human chorionic gonadoptropnin [β-hCG]) no more than 7 days prior to randomization, verified by the treating physician.
- For patients with reproductive potential, agreement to use highly effective method of contraceptive (per Clinical Trial Facilitation Group [CFTG] recommendations) during the trial and for 30 days following the last dose of study intervention
- Willingness to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
- Histologically proven LGSOC (ovarian, fallopian, peritoneal) a. No mixed histology; LGSOC in conjunction with serous borderline tumor is permitted b. Adequate tumor tissue (as defined in the lab manual) must be available for central confirmation of LGSOC. Adequate tumor tissue (as defined in the lab manual) must be received by the central laboratory prior to randomization. If the patient does not have adequate archived tumor tissue or the archived tumor was obtained more than 5 years from informed consent, then a fresh tumor sample will be needed to support eligibility. Central pathological confirmation does not need to be completed prior to randomization.
You likely can't join if
- Received a systemic (targets the entire body) cancer treatment within 4 weeks of the first dose of study therapy;
- Have symptomatic brain cancer or a spinal cord involvement;
- Have an active skin disorder that has required a systemic treatment within 1 year of signing informed consent;
- Have a history of medically significant rhabdomyolysis (rare muscle injury where the muscles break down);
- Have had a serious reaction to a MEK (mitogen-activated protein kinase kinase) inhibitor in the past;
- Have had symptomatic bowel blockage within 3 months prior to treatment;
See the full eligibility criteria
Who can join
- Age ≥ 18 years
- Adequately recovered (Grade ≤ 1 by CTCAE v 5.0) from any toxicities related to prior treatments except alopecia or hypothyroidism.
- For patients with reproductive potential, a negative serum pregnancy test (β human chorionic gonadoptropnin [β-hCG]) no more than 7 days prior to randomization, verified by the treating physician.
- For patients with reproductive potential, agreement to use highly effective method of contraceptive (per Clinical Trial Facilitation Group [CFTG] recommendations) during the trial and for 30 days following the last dose of study intervention
- Willingness to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
- Histologically proven LGSOC (ovarian, fallopian, peritoneal) a. No mixed histology; LGSOC in conjunction with serous borderline tumor is permitted b. Adequate tumor tissue (as defined in the lab manual) must be available for central confirmation of LGSOC. Adequate tumor tissue (as defined in the lab manual) must be received by the central laboratory prior to randomization. If the patient does not have adequate archived tumor tissue or the archived tumor was obtained more than 5 years from informed consent, then a fresh tumor sample will be needed to support eligibility. Central pathological confirmation does not need to be completed prior to randomization.
- Suitable for treatment with at least one of the Investigator’s Choice of Treatments (ie, pegylated liposomal doxorubicin, paclitaxel, letrozole, anastrozole) as determined by the Investigator, given the medical history, prior treatment(s), availability, and approval within a given country, and other relevant factors.
- Documented progression (radiographic or clinical) or recurrence of LGSOC after at least one platinum-based chemotherapy regimen. Allowed prior treatments and therapies include: a. Prior systemic therapy for metastatic disease (International Federation of Gynecology and Obstetrics [FIGO] stage II-IV) may consist of chemotherapy administered with or without bevacizumab, with or without maintenance therapy; or hormonal therapy. b. One prior line of treatment with a MEK and/or RAF inhibitor is permitted only if there was prior clinical benefit (objective response or stable disease ≥ 6 months) and not received within 6 months of signing informed consent.
- Adequate organ function, defined by the following laboratory parameters: a. Adequate hematologic function, including hemoglobin [Hb] ≥ 9.0 g/dL; platelets ≥ 100,000/mm3; and absolute neutrophil count [ANC] ≥ 1500/mm3. If a red blood cell transfusion or erythropoiesis-stimulating agent has been administered the Hb must remain stable and ≥ 9 g/dL for at least 1 week prior to first dose of study intervention. b. Adequate hepatic function: (i) total bilirubin ≤ 1.5 × upper limit of normal [ULN] for the institution; patients with Gilbert syndrome may enroll if total bilirubin is < 3.0 mg/dL (51 μmol/L); (ii) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (or < 5 x ULN in patients with liver metastases). c. Adequate renal function with creatinine clearance rate of ≥ 50 mL/min, as calculated by the Cockcroft-Gault formula or serum creatinine of ≤ 1.5 x ULN. d. International normalized ratio (INR) ≤ 1.5 and partial thromboplastin time (PTT) ≤ 1.5 x ULN in the absence of anticoagulation or therapeutic levels in the presence of anticoagulation. e. Albumin ≥ 3.0 g/dL (451 μmol/L). f. Creatine phosphokinase (CPK) ≤ 2.5 x ULN. g. Adequate cardiac function with left ventricular ejection fraction ≥ 55% by echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan.
- Baseline QTc interval ≤ 460 ms using Fredericia’s QT correction formula. NOTE: This criterion does not apply to patients with a right or left bundle branch block.
- Documented mutational status of KRAS by an approved diagnostic test (eg, CDx, CE marked etc) from tumor tissue (Section 8.4.10). Adequate tumor tissue and matched normal (as defined in the lab manual) must be received by the central laboratory prior to randomization. If the patient does not have adequate archived tumor tissue or the archived tumor was obtained more than 5 years from informed consent, then a fresh tumor sample will be needed to support eligibility. Central confirmation of mutational status does not need to be completed prior to randomization.
- At least one measurable lesion according to RECIST v1.1.
- Eastern Cooperative Group (ECOG) performance status ≤ 1.
What rules you out
- Received a systemic (targets the entire body) cancer treatment within 4 weeks of the first dose of study therapy;
- Have symptomatic brain cancer or a spinal cord involvement;
- Have an active skin disorder that has required a systemic treatment within 1 year of signing informed consent;
- Have a history of medically significant rhabdomyolysis (rare muscle injury where the muscles break down);
- Have had a serious reaction to a MEK (mitogen-activated protein kinase kinase) inhibitor in the past;
- Have had symptomatic bowel blockage within 3 months prior to treatment;
- Currently have eye disorders;
- Currently have heart disease or severe obstructive pulmonary disease;
- Are not able to swallow medicines given by mouth; or Have active, uncontrolled infections (bacterial, viral, or fungal) requiring systemic therapy.
- Currently have high-grade ovarian cancer or another ovarian cancer subtype;
- Have had prior treatment with avutometinib, defactinib, or other FAK kinase inhibitors similar to defactinib;
- Have a history of prior cancer that came back less than 3 years from the time of enrollment;
- Had a major surgery within 4 weeks prior to treatment;
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- United States
- Australia
- Canada
- United Kingdom
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; United States; Australia; Canada; United Kingdom. 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 EU CTIS; the study team decides eligibility.