Trial · NCT03914742

BGB-290 and Temozolomide in Treating Patients With Recurrent Gliomas With IDH1/2 Mutations

NCT03914742, Phase 1, Phase 2, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; results first posted 2024-12-16

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. BGB-290 and Temozolomide in Treating Patients With Recurrent Gliomas With IDH1/2 Mutations. Trials, record NCT03914742. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03914742

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: BGB-290 and Temozolomide in Treating Patients With Recurrent Gliomas With IDH1/2 Mutations
NCT number: NCT03914742
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 67 participants, actual
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions: IDH1 Mutation, IDH2 Mutation, Recurrent Glioblastoma, Recurrent WHO Grade II Glioma, Recurrent WHO Grade III Glioma
Interventions: PARP Inhibitor BGB-290, Temozolomide, Therapeutic Conventional Surgery
First posted: 2019-04-16
Last updated: 2025-01-14
Results first posted: 2024-12-16
Limitations and caveats: This study did finish enrollment for all arms (67 patients) however, due to mandated shut down by NCI/CTEP of our ABTC Consortium not all patients were able to complete treatment on study and/or have PFS or OS mature to use for outcomes (statistics). Additionally, many of the exploratory endpoints were not completed.

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Participants With Dose Limiting Toxicity (DLT) Rate Less Than or Equal to 33% (Dose Level 1)	up to 28 days	DLTS defined as the combination regimen that yields a dose limiting toxicity (DLT) rate less than, or equal to 33%. A DLT is defined as a clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications and meets any of the criteria below. Any DLT must be a toxicity considered at least possibly related to pamiparib (BGB-290) or TMZ.
Primary	Maximum Tolerated Dose	up to 28 days	Patients treated with TMZ 20mg Days 1-28, highest dose level/schedule. If DTL observed, dose level/schedule will de-escalated treatment schedule if necessary (days 1-21; days 1-14; days 1-7) BGG held constant at 60mg PO BID
Primary	Phase II: Overall Best Response Rate for Arm A and Arm B	up to 2 years	Number of participants with response as defined by Response Assessment in Neuro-oncology (RANO) criteria: Complete Response (CR)= no change in size of T1-gadolinium-enhancing (T1-Gd+) disease, stable or reduced T2/FLAIR signal, no new lesion, no corticosteroid use, and stable or improved clinical status; Partial Response (PR)= ≥50% change in size of T1-Gd+ disease, stable or reduced T2/FLAIR signal, no new lesion, stable or reduced corticosteroid use, and stable or improved clinical status; Stable Disease (SD)= \<50% reduction to \<25% increase size of T1-Gd+ disease, stable or reduced T2/FLAIR signal, no new lesion, stable or reduced corticosteroid use, and stable or improved clinical status; Progressive Disease (PD)= ≥25% increase size of T1-Gd+ disease, or increased T2/FLAIR signal, or presence of new lesion, or worsening clinical status.
Secondary	Phase II: Progression-free Survival (PFS) in Arm A and Arm B	up to 2 years	Time from date of treatment start to date of initial scan indicating progression
Secondary	Phase II: Overall Survival (OS) for Arm A and Arm B	up to 2 years	Median time from start date of treatment to date of death
Secondary	Duration of Response Phase 2	up to 2 years	Time from date of initial scan indicating complete or partial response to a date of the initial scan deemed tumor progression. Response is defined by RANO criteria as follows: Complete Response (CR)= no change in size of T1-gadolinium-enhancing (T1-Gd+) disease, stable or reduced T2/FLAIR signal, no new lesion, no corticosteroid use, and stable or improved clinical status; Partial Response (PR)= ≥50% change in size of T1-Gd+ disease, stable or reduced T2/FLAIR signal, no new lesion, stable or reduced corticosteroid use, and stable or improved clinical status; Progressive Disease (PD)= ≥25% increase size of T1-Gd+ disease, or increased T2/FLAIR signal, or presence of new lesion, or worsening clinical status.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Participants With Dose Limiting Toxicity (DLT) Rate Less Than or Equal to 33% (Dose Level 1)	up to 28 days	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Maximum Tolerated Dose	up to 28 days	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Phase II: Overall Best Response Rate for Arm A and Arm B	up to 2 years	participants	NUMBER
SECONDARY	Phase II: Progression-free Survival (PFS) in Arm A and Arm B	up to 2 years	months	MEDIAN
SECONDARY	Phase II: Overall Survival (OS) for Arm A and Arm B	up to 2 years	months	MEDIAN
SECONDARY	Duration of Response Phase 2	up to 2 years	weeks	NUMBER

Source ClinicalTrials.gov

Results by group23

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Participants With Dose Limiting Toxicity (DLT) Rate Less Than or Equal to 33% (Dose Level 1)	Dose Level 1 (Starting Dose)	DLT rate >33%	0	Participants
Participants With Dose Limiting Toxicity (DLT) Rate Less Than or Equal to 33% (Dose Level 1)	Dose Level 1 (Starting Dose)	DLT rate <33%	7	Participants
Maximum Tolerated Dose	Phase 1: Dose Finding	TMZ 20mg 1-28 Days	7	Participants
Maximum Tolerated Dose	Phase 1: Dose Finding	TMZ 20mg 1-21 Days	0	Participants
Maximum Tolerated Dose	Phase 1: Dose Finding	TMZ 20mg 1-14 Days	0	Participants
Phase II: Overall Best Response Rate for Arm A and Arm B	Phase 2: Arm A Alkylator-resistant	Complete Response	0	participants
Phase II: Overall Best Response Rate for Arm A and Arm B	Phase 2: Arm B NOT Alkylator-resistant	Complete Response	0	participants
Phase II: Overall Best Response Rate for Arm A and Arm B	Phase 2: Arm A Alkylator-resistant	Partial Response	0	participants
Phase II: Overall Best Response Rate for Arm A and Arm B	Phase 2: Arm B NOT Alkylator-resistant	Partial Response	1	participants
Phase II: Overall Best Response Rate for Arm A and Arm B	Phase 2: Arm A Alkylator-resistant	Stable disease	9	participants

1 to 10 of 23Source ClinicalTrials.gov

See all 23 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Phase 1: Dose Finding	7
Overall Study	STARTED	Phase 2: Arm A Alkylator-resistant	15
Overall Study	STARTED	Phase 2: Arm B NOT Alkylator-resistant	24
Overall Study	STARTED	GBM Arm	10
Overall Study	STARTED	Surgical Arm	10
Overall Study	COMPLETED	Phase 1: Dose Finding	7
Overall Study	COMPLETED	Phase 2: Arm A Alkylator-resistant	15
Overall Study	COMPLETED	Phase 2: Arm B NOT Alkylator-resistant	24
Overall Study	COMPLETED	GBM Arm	10
Overall Study	COMPLETED	Surgical Arm	10

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events225

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Alanine aminotransferase increase	Investigations	Phase 1: Dose Finding	1	7	2
other	Alanine aminotransferase increase	Investigations	Phase 2: Arm A Alkylator-resistant	3	15	6
other	Alanine aminotransferase increase	Investigations	Phase 2: Arm B NOT Alkylator-resistant	6	24	9
other	Alanine aminotransferase increase	Investigations	GBM Arm	3	10	3
other	Alanine aminotransferase increase	Investigations	Surgical Arm	1	10	2
other	Gastroesophageal Acid Reflux	Gastrointestinal disorders	Phase 1: Dose Finding	3	7	3
other	Gastroesophageal Acid Reflux	Gastrointestinal disorders	Phase 2: Arm A Alkylator-resistant	0	15	0
other	Gastroesophageal Acid Reflux	Gastrointestinal disorders	Phase 2: Arm B NOT Alkylator-resistant	0	24	0
other	Gastroesophageal Acid Reflux	Gastrointestinal disorders	GBM Arm	1	10	2
other	Gastroesophageal Acid Reflux	Gastrointestinal disorders	Surgical Arm	0	10	0

1 to 10 of 225Source ClinicalTrials.gov

See all 225 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase 1: Dose Finding	4	7
Total, all-cause mortality	Phase 2: Arm A Alkylator-resistant	4	15
Total, all-cause mortality	Phase 2: Arm B NOT Alkylator-resistant	6	24
Total, all-cause mortality	GBM Arm	6	10
Total, all-cause mortality	Surgical Arm	3	10
Total, other adverse events	Phase 1: Dose Finding	7	7
Total, other adverse events	Phase 2: Arm A Alkylator-resistant	15	15
Total, other adverse events	Phase 2: Arm B NOT Alkylator-resistant	24	24
Total, other adverse events	GBM Arm	10	10
Total, other adverse events	Surgical Arm	10	10

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
UM1CA137443	Adult Brain Tumor Consortium (ABTC)	GROSSMAN, STUART A	JOHNS HOPKINS UNIVERSITY	NATIONAL CANCER INSTITUTE	2014 to 2020

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03914742

GET https://conductscience.org/api/trials/v1/NCT03914742/results?page=2

API reference For AI assistants