A Phase 1 interventional study of RO6870810 in Solid Tumors, Advanced Solid Tumors, sponsored by Hoffmann-La Roche. Completed at 4 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-05.
Sponsored by Hoffmann-La Roche · Phase 1, Interventional, and Treatment
This is a Phase 1, non-randomized, dose-escalating, open label, multi-center study to be conducted in two parts (Part A and Part B). RO6870810 is a small molecule, non-covalent inhibitor of bromodomain and extra-terminal (BET) family of bromodomains. This study is designed to characterize the safety, tolerability, pharmacokinetics and anti-tumor activity of RO6870810 in participants with histologically confirmed solid tumors with progressive disease (PD) which is refractory or intolerant to standard/approved therapies. In Part A, RO6870810 will be administered by subcutaneous (SC) injection daily for either 21 consecutive days in a 28-day cycle or for 14 consecutive days in a 21-day treatment cycle in participants with advanced solid tumor malignancies to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT). In Part B, RO6870810 will be administered at a dose up to the MTD to further characterize the safety profile and biological effect in a subset of participants with advanced solid tumor malignancies. It is anticipated that a total of 84 participants will be enrolled in to this study (54 in Part A and 30 in Part B). In addition, it is expected that up to 20 participants with histologically confirmed nuclear protein in testis (NUT)-midline carcinoma (NMC) with progressive disease requiring therapy will be enrolled in the sub-study of Parts A and B. In addition, up to 20 participants with diffuse large B-cell lymphoma (DLBCL) may be enrolled at selected study sites.
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General:
Advanced Solid Malignancies:
NUT-midline carcinoma:
Diagnosis of one of the following is required:
Exclusion Criteria:
Participants will receive escalated doses of RO67870810 SC. RO6870810 will be escalated at a starting dose of 0.03 milligrams per kilogram (mg/kg) to a maximum of 0.85 mg/kg. Treatment will be administered in treatment cycles of either 21 days or 28 days and continued until PD, adverse events which justify treatment withdrawal, non-adherence, non-compliance, investigator decision, lost to follow-up, enrollment in other clinical study, or unacceptable toxicity.
Drug: RO6870810
Participants will receive RO6870810 at doses up to the MTD or up to the highest dose tested if the MTD is not defined. Treatment will be administered in treatment cycles of either 21 days or 28 days and continued until PD, adverse events which justify treatment withdrawal, non-adherence, non-compliance, investigator decision, lost to follow-up, enrollment in other clinical study, or unacceptable toxicity.
Drug: RO6870810
Participants will receive RO6870810 at different planned doses with a starting dose of 0.03 mg/kg to a maximum dose of 0.85 mg/kg SC on Days 1 to 14 in a 21-day treatment cycle or on Days 1 to 21 in a 28-day treatment cycle.
Also known as: TEN-010
Number of Participants with DLTs
Time frame: Day 1 up to Day 28 (or Day 21)
MTD of RO6870810
Time frame: Day 1 up to Day 28 (or Day 21)
Percentage of Participants with Adverse Events
Time frame: Baseline up to approximately 47 months
Area Under the Concentration Versus Time Curve from Time 0 (Pre-dose) to Time 24 Hours (AUC0-24) of RO6870810
Pre-injection (Hour 0), immediately post-injection, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 24 and 28 hours post-injection on Day 1 Cycle 1; Pre-injection (Hour 0), immediately post-injection, 0.25, 0.5, 1, 2, and 4 hours post-injection on Day 15 Cycle 1; random samples on Days 8, 22 of Cycle 1 and on Day 1 of Cycle 2 and every cycle thereafter up to treatment completion (up to 47 months), end of treatment visit/early termination (up to 47 months) (cycle length = 21 or 28 days)
Time frame: Baseline up to 47 months (detailed timeframe is provided in the outcome description)
Maximum Plasma Concentration (Cmax) of RO6870810
Pre-injection (Hour 0), immediately post-injection, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 24 and 28 hours post-injection on Day 1 Cycle 1; Pre-injection (Hour 0), immediately post-injection, 0.25, 0.5, 1, 2, and 4 hours post-injection on Day 15 Cycle 1; random samples on Days 8, 22 of Cycle 1 and on Day 1 of Cycle 2 and every cycle thereafter up to treatment completion (up to 47 months), end of treatment visit/early termination (up to 47 months) (cycle length = 21 or 28 days)
Time frame: Baseline up to 47 months (detailed timeframe is provided in the outcome description)
Time to Reach Cmax (Tmax) of RO6870810
Pre-injection (Hour 0), immediately post-injection, 0.25, 0.5, 1, 2, 4, 6, 8, 10, 24 and 28 hours post-injection on Day 1 Cycle 1; Pre-injection (Hour 0), immediately post-injection, 0.25, 0.5, 1, 2, and 4 hours post-injection on Day 15 Cycle 1; random samples on Days 8, 22 of Cycle 1 and on Day 1 of Cycle 2 and every cycle thereafter up to treatment completion (up to 47 months), end of treatment visit/early termination (up to 47 months) (cycle length = 21 or 28 days)
Time frame: Baseline up to 47 months (detailed timeframe is provided in the outcome description)
Percentage of Participants with Objective Response (Complete Response [CR] or Partial Response [PR]) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 as Determined by the Investigator
Screening up to PD/death whichever occurs first (assessed at screening, Day 1 of Cycle 1 and every odd numbered cycle up to treatment completion \[up to 47 months\], end of treatment visit \[up to 47 months\], and every 12 weeks thereafter up to study completion \[up to 47 months\]) up to 47 months (cycle length=21 or 28 days)
Time frame: Baseline up to 47 months (detailed timeframe is provided in the outcome description)
Median Time Taken for the First Response Based on RECIST v 1.1 as Determined by the Investigator
Screening up to PD/death whichever occurs first (assessed at screening, Day 1 of Cycle 1 and every odd numbered cycle up to treatment completion \[up to 47 months\], end of treatment visit \[up to 47 months\], and every 12 weeks thereafter up to study completion \[up to 47 months\]) up to 47 months (cycle length = 21 or 28 days)
Time frame: Baseline up to 47 months (detailed timeframe is provided in the outcome description)
Median Time Taken for the Best Overall Response Based on RECIST v 1.1 as Determined by the Investigator
Screening up to PD/death whichever occurs first (assessed at screening, Day 1 of Cycle 1 and every odd numbered cycle up to treatment completion \[up to 47 months\], end of treatment visit \[up to 47 months\], and every 12 weeks thereafter up to study completion \[up to 47 months\]) up to 47 months (cycle length = 21 or 28 days)
Time frame: Baseline up to 47 months (detailed timeframe is provided in the outcome description)
Progression Free Survival Based on RECIST v 1.1 as Determined by the Investigator
Screening up to PD/death whichever occurs first (assessed at screening, Day 1 of Cycle 1 and every odd numbered cycle up to treatment completion \[up to 47 months\], end of treatment visit \[up to 47 months\], and every 12 weeks thereafter up to study completion \[up to 47 months\]) up to 47 months (cycle length = 21 or 28 days)
Time frame: Baseline up to 47 months (detailed timeframe is provided in the outcome description)
Duration of Response Based on RECIST v 1.1 as Determined by the Investigator
Screening up to PD/death whichever occurs first (assessed at screening, Day 1 of Cycle 1 and every odd numbered cycle up to treatment completion \[up to 47 months\], end of treatment visit \[up to 47 months\], and every 12 weeks thereafter up to study completion \[up to 47 months\]) up to 47 months (cycle length = 21 or 28 days)
Time frame: Baseline up to 47 months (detailed timeframe is provided in the outcome description)
Overall Survival
Time frame: Screening up to death due to any cause (up to approximately 47 months)
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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