CUSP06 for Ovarian Cancer
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: OnCusp Therapeutics, Inc.
No Placebo Group
Trial Summary
What is the purpose of this trial?This phase 1 study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of CUSP06 in patients with platinum-refractory/resistant ovarian cancer and other advanced solid tumors.
Is the treatment CUSP06 a promising treatment for ovarian cancer?The information provided does not mention CUSP06 or its effectiveness, so we can't say if it's promising based on this data.467810
What safety data is available for the CUSP06 treatment for ovarian cancer?The provided research does not directly mention safety data for the CUSP06 treatment for ovarian cancer. However, it includes information on the safety profiles and management of adverse events for similar treatments like olaparib and rucaparib, which are poly(ADP-ribose) polymerase inhibitors used in ovarian cancer treatment. These studies discuss adverse events such as gastrointestinal symptoms, fatigue, anemia, and liver enzyme changes, and provide strategies for managing these events to optimize patient outcomes.311121314
What data supports the idea that CUSP06 for Ovarian Cancer is an effective treatment?The available research does not provide specific data on the effectiveness of CUSP06 for Ovarian Cancer. Instead, it focuses on other treatments and factors related to ovarian cancer, such as intraperitoneal therapy, hormone therapy, and clinical management. Without direct evidence from these studies, we cannot conclude that CUSP06 is effective for treating ovarian cancer.12579
Do I need to stop my current medications to join the trial?The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had systemic antineoplastic therapy within 5 half-lives or 4 weeks before the first dose of the study drug. It's best to discuss your specific medications with the trial team.
Eligibility Criteria
This trial is for adults over 18 with advanced solid tumors, including ovarian cancer that's not responding to platinum-based treatments. Participants need a certain level of health (ECOG status 0 or 1), enough white blood cells, platelets, and hemoglobin without recent transfusions. They must provide tumor tissue samples and consent to biopsies if needed.Inclusion Criteria
I have an advanced solid tumor and have either been treated with standard therapy or no standard therapy exists for me.
I can care for myself and am expected to live at least 12 more weeks.
Exclusion Criteria
I have a lung condition that needed steroid treatment in the last 6 months.
I have had a bone marrow transplant from another person.
I have been treated with a drug that targets cancer cells and carries a specific toxin.
I have had a liver transplant.
My cancer has spread to my brain or is affecting the lining of my brain and spinal cord.
I have lasting side effects from cancer treatment, but not hair loss or skin changes.
I haven't taken any cancer drugs or been in a drug study within the last 4 weeks.
I haven't had extensive radiotherapy in the last 4 weeks or targeted palliative radiotherapy in the last 2 weeks.
I have pancreatitis or cirrhosis, but not mild cirrhosis (Child-Pugh A).
I do not have any serious infections including HBV, HCV, or HIV.
I haven't had any cancer other than my current one in the last 3 years.
Treatment Details
CUSP06 is being tested in this phase 1 study for safety and effectiveness in treating resistant ovarian cancer and other solid tumors. The trial will assess how the body processes the drug (pharmacokinetics) as well as its impact on the disease.
2Treatment groups
Experimental Treatment
Group I: Monotherapy Dose Finding - Phase 1aExperimental Treatment1 Intervention
Group II: Expansion as Monotherapy - Phase 1bExperimental Treatment1 Intervention
Find a clinic near you
Research locations nearbySelect from list below to view details:
MD Anderson Cancer CenterHouston, TX
Sarah Cannon Research Institute at HealthONEDenver, CO
Dana Farber Cancer InstituteBoston, MA
Stephenson Cancer CenterOklahoma City, OK
More Trial Locations
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Who is running the clinical trial?
OnCusp Therapeutics, Inc.Lead Sponsor
References
Staging procedures, clinical management, and survival outcome for ovarian carcinoma. [2016]To evaluate the relationship between survival and patterns of clinical management for ovarian carcinoma.
[Prognostic factors for survival of ovarian epithelial cancers: apropos of 287 cases]. [2016]To evaluate survival and assess prognostic factors in patients with epithelial ovarian cancer.
Oral contraceptives and ovarian cancer: an update, 1998-2004. [2006]Over the last two decades, ovarian cancer incidence and mortality for younger generations have been declining in most developed countries, and the decline has been greatest in countries where oral contraceptive (OC) use had spread earlier. The overall estimated protection from cohort and case-control studies is approximately 30% for ever OC users, and increases with duration of use by approximately 5% per year of use to about 50% for long-term (> or =10 years) users. The favourable effect of OC against ovarian cancer risk persists for at least 20 years after OC use has ceased, and it is not confined to any particular type of OC formulation. The reduced risk among OC users is observed in women without or with family history or genetic predisposition to ovarian cancer, and for most histological types of epithelial ovarian cancer, although the pattern of risk is less consistent for mucinous than for other types. The protection of OC on ovarian cancer risk, also in view of its long-term persistence, corresponds to the avoidance of 3000-5000 ovarian cancers (and 2000-3000 deaths) per year in Europe, and a similar figure in North America.
Effect of BRCA1/2 mutations on long-term survival of patients with invasive ovarian cancer: the national Israeli study of ovarian cancer. [2022]To evaluate the long-term survival of ovarian cancer (OvC) patients in total and by BRCA1/2 mutation status.
Survival after second-line intraperitoneal therapy for the treatment of epithelial ovarian cancer: the Gynecologic Oncology Group experience. [2021]To assess the association between patient-disease characteristics and overall survival (OS) after second-line intraperitoneal (IP) treatment of ovarian cancer.
Study of the molecular recognition of aptamers selected through ovarian cancer cell-SELEX. [2021]Ovarian cancer is the most lethal gynecological malignancy, and the ovarian clear cell carcinoma subtype (OCCA) demonstrates a particularly poor response to standard treatment. Improvements in ovarian cancer outcomes, especially for OCCA, could be expected from a clearer understanding of the molecular pathology that might guide strategies for earlier diagnosis and more effective treatment.
Adjuvant Hormone Therapy May Improve Survival in Epithelial Ovarian Cancer: Results of the AHT Randomized Trial. [2019]To assess the effects of adjuvant hormone therapy (AHT) on survival and disease outcome in women with epithelial ovarian cancer.
Demographic Clinical and Prognostic Factors of Primary Ovarian Adenocarcinomas of Serous and Clear Cell Histology-A Comparative Study. [2022]To compare clinical demographic and prognostic factors as well as overall survival in a nationwide cohort of patients diagnosed with ovarian clear cell carcinoma (oCCC) and high grade ovarian serous adenocarcinoma (oSAC) during 2005 to 2013.
Predictive factors of recurrence in patients with early-stage epithelial ovarian cancer. [2019]To identify predictive factors of recurrence and survival in patients with early-stage epithelial ovarian cancer (eEOC).
Fifteen-year survival of invasive epithelial ovarian cancer in women with BRCA1/2 mutations - the National Israeli Study of Ovarian Cancer. [2019]Compare 5, 10 and 15 year survival in invasive epithelial ovarian cancer, between patients with and without BRCA1/2 germ line mutation in a nonselective group of patients diagnosed during 1994-99.
Evaluation of toxicities related to novel therapy in clinical trials for women with gynecologic cancer. [2023]Women with gynecologic cancer may be at increased risk for adverse events (AEs) due to peritoneal disease burden and prior treatment (surgery, chemotherapy, and pelvic radiotherapy). This study compared the toxicity profiles of patients with and without gynecologic cancer enrolled in phase 1 trials.
Management of Adverse Events During Rucaparib Treatment for Relapsed Ovarian Cancer: A Review of Published Studies and Practical Guidance. [2023]The poly(ADP-ribose) polymerase inhibitor rucaparib is approved as monotherapy in the treatment and maintenance settings for women with relapsed ovarian cancer in the European Union and the United States. We review the safety profile of rucaparib in both settings and provide recommendations for the clinical management of the main adverse events (AEs) that may occur during rucaparib treatment. We searched PubMed and congress proceedings for safety data on oral rucaparib monotherapy (600 mg twice daily) from clinical trials involving patients with relapsed ovarian cancer. AE management guidance was developed from clinical trial protocols, rucaparib prescribing information, oncology association guidelines, and author experience. The most frequent any-grade treatment-emergent AEs (TEAEs) included gastrointestinal symptoms, asthenia/fatigue, dysgeusia, anemia/decreased hemoglobin, and increased alanine/aspartate aminotransferase. Across clinical trials, 61.8% of patients had one or more grade 3 or higher TEAEs. Clinicians should employ close follow-up for TEAEs, particularly early in treatment, and educate patients about expected TEAEs and methods for their monitoring and management (e.g., antiemetics for nausea/vomiting, transfusions for hematologic TEAEs, or dose interruptions/reductions for moderate/severe TEAEs). Overall, 16.2% of patients discontinued rucaparib due to TEAEs. Management of AEs that may occur during rucaparib treatment is crucial for patients to obtain optimal clinical benefit by remaining on therapy and to avoid their detrimental impact on quality of life.
Olaparib dose re-escalation in ovarian cancer patients who experienced severe and/or uncommon adverse events: A case series. [2021]Few real-world studies have reported detailed management and dose adjustment strategies of adverse events (AEs) of ovarian cancer (OC) patients treated with the poly(adenosine diphosphate-ribose) polymerase inhibitor olaparib. This case series aimed to describe olaparib AEs in Chinese OC patients in real-life settings and to explore dose modification strategies.
A multi-method approach to selecting PRO-CTCAE symptoms for patient-reported outcome in women with endometrial or ovarian cancer undergoing chemotherapy. [2023]Women with endometrial or ovarian cancer experience a variety of symptoms during chemotherapy. Patient-Reported outcomes (PROs) can provide insight into the symptoms they experience. A PRO tool tailored to this patient population can help accurately monitor adverse events and manage symptoms. The objective of this study was to identify items in the National Cancer Institute's measurement system Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) appropriate for use in a PRO tool for a population of women with endometrial or ovarian cancer undergoing treatment with taxanes (paclitaxel or docetaxel) in combination with carboplatin.