Trial · NCT03377179
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part1 - Determine Response Rate | At least 4 months | To determine the response rate (RR) of CCA defined as objective responses (OR), i.e. complete and partial responses (CR, PR) plus stable disease (SD) of at least 4 months to treatment with ABC294640. |
| Primary | Part 2 - Determine the Durable Disease Control Rate | At least 4 months | To determine the Durable Disease Control Rate (DDCR) of CCA defined as Disease Control Rate (DCR) of at least 4 months duration to treatment with ABC294640 and HCQ |
| Secondary | Physical exam to include eye exams (the latter only for patients enrolled in Part 2) to measure safety and tolerability of ABC294640 alone and in combination with HCQ | From screening phase, during beginning of each cycle of treatment, till 30 days after the end of treatment (an estimated median of 5 months) | A physical exam which will include weight measurment in kilograms will be performed in screening and on the beginning of each cycle of treatment till 30 day post treatment. |
| Secondary | A general neurological exam to measure safety and tolerability of ABC294640 alone and in combination with HCQ | From screening phase, during beginning of each cycle of treatment, till 30 days after the end of treatment (an estimated median of 5 months) | A general neurological exam will be performed in screening and on the beginning of each cycle of treatment till 30 day post treatment. |
| Secondary | HADS score for depression and anxiety to measure safety and tolerability of ABC294640 alone and in combination with HCQ | From screening, during each cycle of treatment, till the end of treatment (an estimated median of 4 months). Patient diaries will be filled on a daily basis during treatment. | HADS (Hospital Anxiety and Depression Scale) questionnaire will be utilized to monitor any alterations in the participant's anxiety and depression levels. |
| Secondary | ECOG performance score to measure safety and tolerability of ABC294640 alone and in combination with HCQ | From screening, during each cycle of treatment, till the end of treatment (an estimated median of 4 months). Patient diaries will be filled on a daily basis during treatment. | ECOG (Eastern Cooperative Oncology Group) performance score to the participant's performance status and how it is impacting the daily living abilities. |
| Secondary | MMSE score to measure safety and tolerability of ABC294640 alone and in combination with HCQ | From screening, during each cycle of treatment, till the end of treatment (an estimated median of 4 months). Patient diaries will be filled on a daily basis during treatment. | MMSE (Mini-Mental State Examination) questionnaire will be utilized for evaluating the mental state of the participants. |
| Secondary | Daily diary entries to aid in asessing safety and tolerability of ABC294640 alone and in combination with HCQ | From screening, during each cycle of treatment, till the end of treatment (an estimated median of 4 months). Patient diaries will be filled on a daily basis during treatment. | Participants will be asked to fill a daily diary to record the drug administration and any side effects that they may experience. |
| Secondary | Number of treatment-related Adverse Events alone and in combination with HCQ | From screening till the 30 days after the end of treatment (an estimated median of 5 months) | Adverse events will be graded according to the revised NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE version 4.03) to measure the safety and tolerability of treatment with ABC294640 alone and in combination with HCQ in patients with unresectable CCA. |
| Secondary | The Maximum Plasma Concentration (Cmax) of ABC294640 and of HCQ | From the first day of treatment until the beginning of second cycle of treatment (on day 1, 15, 28 approximately) | To determine the pharmacokinetics of ABC294640 (Part 1) and of ABC294640 and HCQ (Part 2) in the first 12 patients by measuring Maximum Plasma Concentration (Cmax) of ABC294640 and HCQ |
| Secondary | The Area Under the Curve (AUC) of ABC294640 (Part 1) and of ABC294640 and HCQ (Part 2) | From the first day of treatment until the beginning of second cycle of treatment (on day 1, 15, 28 approximately) | To determine the pharmacokinetics of ABC294640 (Part 1) and of ABC294640 and HCQ (Part 2) in the first 12 patients by measuring the Area Under the Curve (AUC) of ABC294640 and of HCQ which reflects the body exposure to drug after administration of a dose of the drug. |
| Secondary | Determine the progression free survival (PFS) | Every 2 months for a maximum of 24 months after the last participant has been entered to the study | |
| Secondary | Determine Disease Control Rate (DCR=CR+PR+SD) | Every 2 months for a maximum of 24 months after the last participant has been entered to the study | Determine Disease Control Rate (DCR) = complete response (CR)+ partial response (PR) + stable disease (SD) |
| Secondary | Determine the overall survival (OS) | Every 2 months for a maximum of 24 months after the last participant has been entered to the study | |
| Other | Determine the effect of treatment with ABC294640 alone or in combination with HCQ on pharmacodynamic markers that are associated with the mechanism of action of the drug. | Within 21 days prior to treatment and on the beginning of the second cycle of treatment (approximately a month) | Tumor biopsies, when accessible, will be obtained and will be assessed for tumor signaling proteins (c-Myc, pAKT, SK2). Peripheral Blood Mononuclear Cells (PBMC) for c-Myc will be collected within 1 hour prior to the pre- and posttreatment biopsies (or at the scheduled time of biopsy if not performed). |
| Other | Serial measurement of circulating tumor DNA (ctDNA) | Prior to treatment till the end of study (assessed at screening, beginning of cycle three of treatment and every 8 weeks thereafter, up to 24 months) | Serum ctDNA be assessed for mutational status and development of new mutations. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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