PTC-596 in Women With Ovarian Cancer Receiving Neoadjuvant Chemotherapy

• Status: Recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is an open-label Phase Ib dose-escalation study to determine the safety, tolerability, and pharmacokinetics of PTC-596 when combined with and following conventional chemotherapy and as maintenance therapy as a capsule (weight based dosing) and a tablet (fixed dosing) in women with epithelial ovarian, fallopian tube or primary peritoneal cancer which is previously untreated.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oklahoma
• Collaborator: PTC Therapeutics
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

• Histologically documented epithelial ovarian, primary peritoneal or fallopian tube carcinoma or high grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma,or adenocarcinoma not otherwise specified (N.O.S.)

• Newly diagnosed and be previously untreated

• Adequate bone marrow function, renal function, and hepatic function

• Baseline neuropathy (sensory and motor) less than or equal to Grade 1

• Free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.

• Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy is permitted.

• Have a performance status score of 0, 1, or 2 by Eastern Cooperative Group (ECOG) criteria.

• Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.

Exclusion Criteria:

• Prior treatment with PTC596 or standard of care drugs (cis- or carboplatin or paclitaxel.

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to PTC596 or other agents used in this study.

• Have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration.

• Receiving treatment for active autoimmune disease including systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.

• History of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy. Patients with concomitant endometrial cancer diagnosed at the time of their ovarian cancer are allowed to participate if the endometrial cancer is FIGO stage IB or less.

• Prior radiotherapy to any portion of the abdominal cavity or pelvis. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted if completed more than three years prior to registration and the patient remains free of recurrent or metastatic disease.

• Prior chemotherapy for any abdominal or pelvic tumor. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed three years prior to registration, and that the patient remains free of recurrent or metastatic disease.

• Known active hepatitis, ongoing systemic bacterial, fungal, or viral infection; known human immunodeficiency virus (HIV) infection or acquired-immunodeficiency syndrome (AIDS)-related illness.

• Have concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.

• Have childbearing potential but not practicing adequate contraception, or pregnant, or breastfeeding.

• History or active CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months prior to study treatment.

• Concomitant therapy with any of the following: other non-study cytotoxic chemotherapy; other investigational therapies.

• Prior bone marrow/hematopoietic stem cell transplantation

• Use of an investigational drug within 4 weeks of dosing in the current study

• History of major surgical procedure within 28 days prior to start of study treatment

• Presence of history of moderate to severe pulmonary dysfunction (e.g., moderate/severe chronic obstructive pulmonary disease, post-pneumoectomy, shortness of breath with limited exertion).