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RecruitingLast updated: 3 March 2026

RAMP 301: This study will assess how safe and effective the combination of two targeted therapies (avutometinib and defactinib) is compared to other treatments in people with recurrent low-grade serous ovarian cancer (LGSOC) who have progressed on prior platinum-based therapyA 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)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Female Reproductive System Cancers Gynaecological

Age

People18+

Trial acronym

RAMP 301

Clinical summary

Summary

Avutometinib and Defactinib are both a type of drug called a kinase inhibitor. Kinase inhibitors block cancer cell growth.

Eligible participants will be randomly allocated to one of two treatment arms. Treatment cycles will be 28-days (4 weeks) in both treatment arms.

In the Experimental Arm, participants will receive Avutometinib and Defactinib. Avutometinib will be given orally, twice weekly for 21 days on, 7 days off, with Defactinib given orally twice daily for 21 days on, 7 days off.

In the Active Comparator Arm, participants will receive one of the following standard of care treatments as determined by the Investigator:

  • Pegylated Liposomal Doxorubicin, administered intravenously (via IV) on Day 1 of each cycle.
  • Paclitaxel chemotherapy, via IV, on Days 1, 8 and 15.
  • Topotecan, via IV, on Days 1, 8 and 15.
  • Anastrozole, orally, once daily.
  • Letrozole, orally, once daily.

Participants who originally receive one of the standard of care treatments who are determined to have progressive disease may be eligible to crossover to receive the investigational combination.

Conditions

This trial is treating people with low-grade serous ovarian cancer (ovarian, fallopian, peritoneal)

Eligibility

Inclusion

Patients may be eligible for inclusion in the study if they meet the following criteria:

  1. Histologically proven LGSOC (ovarian, fallopian, peritoneal)
  2. Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.
  3. Measurable disease according to RECIST v1.1.
  4. An Eastern Cooperative Group (ECOG) performance status ≤ 1.
  5. Adequate organ function
  6. Adequate recovery from toxicities related to prior treatments.
  7. For patients with reproductive potential, Agreement to use highly effective method of contraceptive.
  8. Willingness to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures

Exclusion

Patients will be excluded from the study if they meet any of the following criteria:

  1. Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy.
  2. Co-existing high-grade ovarian cancer or another histology.
  3. Prior treatment with avutometinib, defactinib, or other FAK inhibitors.
  4. History of prior malignancy with recurrence <3 years from the time of enrollment.
  5. Major surgery within 4 weeks.
  6. Symptomatic brain metastases or spinal cord compression.
  7. An active skin disorder that has required systemic therapy within one year of signing informed consent.
  8. History of medically significant rhabdomyolysis.
  9. For subjects with prior MEK exposure, Grade 4 toxicity deemed related to the MEK inhibitor.
  10. Symptomatic bowel obstruction within 3 months.
  11. Concurrent ocular disorders.
  12. Concurrent heart disease or severe obstructive pulmonary disease.
  13. Subjects with the inability to swallow oral medications.
  14. Active, uncontrolled infection (bacterial, viral, or fungal) requiring systemic therapy.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Verastem, Inc.

Scientific Title

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)

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