Trial Annotation Process and Criteria for Highlighting Results

Trial Annotation Process

Trials available (i.e., actively recruiting or not yet recruiting) to ovarian cancer patients in the USA were identified by a weekly search of ClinicalTrials.gov.

Criteria for inclusion and exclusion for each trial were reviewed and annotated for eligible tumor histology types, number and types of prior therapies, as well as clinical characteristics such as platinum response status and presence of measurable disease.

  • In some cases, the trial protocol description did not explicitly state requirements for a given criterion or allowed enrollment of patients with different characteristics in the arms or sub-protocols. All such trials are provided in the search results for the user to further investigate.
  • Patients with a diagnosis of a second cancer type are assumed to be excluded from the trial unless the description states otherwise.

Our search tool aims to be comprehensive and to simplify the identification of trials that best match the patient clinical and tumor characteristics of eligible patients, but we cannot guarantee that the filtering process is perfect or that all active trials are represented.  Please let us know if you discover any errors or omissions.

Please be sure to carefully review the full eligibility descriptions for any trial of interest, including criteria regarding laboratory test results and other clinical conditions prior to contacting the trial site.

 

Criteria for Highlighting Trial Results as Promising

Trials are highlighted when the experimental therapy is reported to be at least as effective as Standard of Care (SoC)* OR a similar drug (s) with Phase II/III results for patients in a similar clinical situation.  Efficacy measures are ORR and/or PFS as indicated below for trials with data for at least 12 ovarian cancer patients and at least 1 reported CR or PR for trials that have fewer than 12 patients.

If the therapy effectiveness is comparable to SoC, at least one of the following criteria must also apply:

  • Trial drug(s) has a better side effect profile than Standard of Care*
  • Trial drug(s) has a novel molecular target
  • Trial uses a response prediction biomarker that identified responsive patients
  • Trial drug(s) shows activity in less common ovarian cancer histology types (e.g., clear cell , low grade serous, mucinous, carcinosarcoma, granulosa cell)

 

*Standard of Care treatments are as described in National Comprehensive Cancer Network (NCCN) guidelines (and on this website).

Standard of care efficacy metrics used in the experimental therapy comparisons were assigned based on platinum response status of the trial participants:

Platinum Sensitive (Pt-S):   ORR  60%;  PFS 10 months

Platinum Resistant (Pt-R): ORR  15%;  PFS  4 months (NB. for combination therapies: ORR 25%, PFS 6 months)