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NCT03150810 · ClinicalTrials.gov registry record · Phase 1

Study to Assess Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Participants With Locally Advanced or Metastatic Solid Tumors

A Phase 1 study, sponsored by BeiGene.

Completed
Registry status
Phase 1
Development phase
139
Enrollment target

NCT03150810: Completed Phase 1 study, sponsored by BeiGene.

NCT03150810 is a Phase 1 study that has completed, run by BeiGene. The registered enrollment target is 139 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (132% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03150810, a Phase 1 study, has completed, sponsored by BeiGene.

COMPLETED
Registry status
Phase 1
Development phase
139 participants
Enrollment target

Study Summary

The primary objective of this study was to determine the safety and tolerability of pamiparib, the maximum tolerated dose (MTD) or maximum administered dose (MAD) for pamiparib combined with TMZ, to select the recommended Phase 2 dose (RP2D) and schedule of pamiparib in combination with TMZ, and to determine the antitumor activity of pamiparib in combination with TMZ.

Primary Outcome

A DLT is defined as one of the following toxicities occurring during the DLT assessment window: Grade ≥3 non-hematologic, non-hepatic major organ adverse event (AE) Grade 4 neutropenia lasting \>7 days Grade ≥3 febrile neutropenia Grade 3 thrombocytopenia with clinically significant bleeding Grade 4 thrombocytopenia lasting \> 3 days and requiring transfusion, or any decreased platelet count \<15,000/mm3/ \<15.0 x 109/L Grade ≥4 anemia Grade ≥3 total bilirubin or hepatic transaminases (ALT or A

Interventions

  • DRUG Pamiparib
  • DRUG Temozolomide

Trial Details

FieldValue
Enrollment Target 139 participants
Start Date 2017-06-28
Est. Completion 2023-05-04
Phase Phase 1
BeiGene

65 total trials

What the finished NCT03150810 record still lists

NCT03150810 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (132% higher).

The record links to 0 conditions, and to 2 interventions - of which Pamiparib is the first listed.

NCT03150810 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03150810 about?

NCT03150810 is a clinical study titled "Study to Assess Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Participants With Locally Advanced or Metastatic Solid Tumors". The primary objective of this study was to determine the safety and tolerability of pamiparib, the maximum tolerated dose (MTD) or maximum administered dose (MAD) for pamiparib combined with TMZ, to select the recommended Phase 2 dose (RP2D) and schedule of pamiparib in combination with TMZ, and to ...

What is the current status of trial NCT03150810?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 139 participants. The study started on 2017-06-28. Estimated completion is 2023-05-04.

What interventions are being tested in trial NCT03150810?

The interventions under investigation include: Pamiparib (DRUG), Temozolomide (DRUG).

Who is sponsoring clinical trial NCT03150810?

This trial is sponsored by BeiGene, which has 65 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03150810's enrollment target sits among peer trials

139 418th of 2000 higher than 1,583 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03150810, the US trial registry maintained by the National Library of Medicine. NCT03150810 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.