TerminatedPhase 1

A Study to Evaluate the Tolerability, Safety, Pharmacokinetics of HEC89736 in Patients With Relapsed or Refractory B-cell Hematologic Malignancies

Stopped: Adjustment to the sponsor's development strategy

China5 participantsStarted 2021-04-01

Plain-language summary

Evaluate the safety, pharmacokinetics and efficacy of HEC89736 in patients with Relapsed or Refractory B-cell Hematologic Malignancies

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age is over 18 years old * Histologically or cytologically diagnosed patients with recurrent or refractory B-cell malignancies * ECOG performance status (PS) 0 \~ 1 * Expected survival of \> or = 3 months Exclusion Criteria: * The use of PI3Ks as the target of anti-tumor drugs progress (due to intolerance group) * Received any other anti-cancer treatment within 4 weeks * Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors that affect drug use and absorption * Allergy, or known to have a history of allergy to the drug components

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dose limited toxicities evaluated with NCI-CTC AE v5.0 after the first dose

Timeframe: Dosing started until the 28th day

Adverse events evaluated by NCI CTCAE 5.0

Timeframe: From the frst dose to within 30 days after the last dose

Trial details

NCT IDNCT04865458

SponsorSunshine Lake Pharma Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-21

View on ClinicalTrials.gov More Relapsed or Refractory B-cell Hematologic Malignancies trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.