Continuation of Oral ONC201 in Treating Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT02324621|
Recruitment Status : Recruiting
First Posted : December 24, 2014
Last Update Posted : August 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor||Drug: Oral ONC201 Other: pharmacological study Other: laboratory biomarker analysis||Phase 1|
I. To evaluate the long-term safety and tolerability of ONC201 (oral ONC201) administered orally in patients with advanced cancers.
I. To characterize pharmacokinetics of ONC201. II. To assess serum biomarkers of therapeutic response to ONC201. III. To assess preliminary antitumor activity of ONC201 as a single agent in advanced solid tumors.
Patients receive oral ONC201 orally (PO) on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Continuation Clinical Trial of Every Three-Week Dosing of Oral ONC201 in Patients With Advanced Solid Tumors|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
Experimental: Treatment (oral ONC201)
Patients receive oral ONC201 PO on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: Oral ONC201
Other: pharmacological study
Other Name: pharmacological studies
Other: laboratory biomarker analysis
- Incidence of adverse experiences from oral ONC201 using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 4 weeks after end of study treatment ]An adverse experience is defined as any unintended or abnormal clinical observation that is not of benefit to the patient. Either the condition was not present prior to exposure to the study therapy, or it has worsened in intensity or frequency following exposure to the study therapy. Descriptive statistics will be provided.
- Frequency of toxicities associated with ONC201 [ Time Frame: Up to 4 weeks after end of study treatment ]
- Response rate of oral ONC201 in patients with advanced solid tumors [ Time Frame: At 3 months ]
- Pharmacokinetic parameters [ Time Frame: Up to 4 weeks of therapy ]The oral ONC201 concentration, and the corresponding time, area under the curve, elimination half-life, total body clearance and volume of distribution will be determined for each patient concentration-time data using a non-compartmental model. Descriptive statistics will be provided.
- Clinical benefit rate (stable disease and partial disease) [ Time Frame: At 3 months ]
- Time to progressive disease [ Time Frame: Up to 4 weeks after end of study treatment ]Descriptive statistics on continuous data will include means, medians, standard deviations, and ranges will be provided to estimate clinical benefit rate.
- Changes in serum biomarkers of therapeutic response [ Time Frame: Baseline to up to 4 weeks after end of study treatment ]Descriptive statistics will be provided.
- Changes in molecular targets of oral ONC201 [ Time Frame: Baseline to up to 4 weeks after end of study treatment ]Descriptive statistics will be provided.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324621
|Contact: Clinical Trials Office||732-235-7521|
|United States, New Jersey|
|Rutgers Cancer Institute of New Jersey||Recruiting|
|New Brunswick, New Jersey, United States, 08903|
|Contact: Jyoti Malhotra 732-235-7521 firstname.lastname@example.org|
|Principal Investigator: Jyoti Malhotra|
|Principal Investigator:||Jyoti Malhotra||Rutgers Cancer Institute of New Jersey|