Trial · NCT01791595
A Phase I Trial of AZD3965 in Patients With Advanced Cancer
NCT01791595, Phase 1, Completed, Cancer Research UK; results first posted 2022-04-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase I Trial of AZD3965 in Patients With Advanced Cancer. Trials, record NCT01791595. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01791595
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase I Trial of AZD3965 in Patients With Advanced Cancer
- NCT number
- NCT01791595
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 53 participants, actual
- Lead sponsor
- Cancer Research UK
- Conditions
- Adult Solid Tumor, Diffuse Large B Cell Lymphoma, Burkitt Lymphoma
- Interventions
- AZD3965, AZD3965, AZD3965, AZD3965, AZD3965, AZD3965, AZD3965
- First posted
- 2013-02-15
- Last updated
- 2022-04-11
- Other registries' IDs
- eudract:2010-024463-41
- Results first posted
- 2022-04-11
- Limitations and caveats
Lactate accumulation in peripheral blood mononuclear cells was originally a measure for assessment of the primary objective but the assay was confounded by methodological problems and high inter-patient variability. This measure was removed for Part 2 and not used for assessment of the primary objective. M30, M65 and nDNA assays are only quasi quantitative; data \>upper limit substituted with upper limit and data \<lower limit substituted with lower limit/2.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MTD of AZD3965 | Day -7 to Day 28 | MTD was determined by testing increasing AZD3965 doses in Part 1 dose escalation cohorts (Cohorts 1-6) and defined as the total daily dose level below that at which ≥2 out of ≤6 evaluable patients had a dose-limiting toxicity (DLT) during Cycle 1 (including Day -7). DLTs were defined as highly probably/probably AZD3965 related haematological, cardiac, ophthalmic, other Grade 3/4 toxicity, death or drug-related toxicity causing AZD3965 interruption \>2 weeks (see protocol for specific criteria) |
| Primary | Number of Patients Who Experienced DLTs | Day -7 to Day 28 | Number of patients who experienced protocol-defined DLTs (defined according to NCI CTCAE version 4.02). DLTs were defined as highly probably/probably AZD3965 related haematological, cardiac, ophthalmic, other Grade 3/4 toxicity, death or drug-related toxicity causing AZD3965 interruption \>2 weeks (see protocol for specific criteria) |
| Primary | Number of Patients Who Experienced Serious AEs | From the date of written informed consent and until 28 days after the last dose of AZD3965; an average (median) of 80 days (range: 36 to 517 days) | A serious adverse event (SAE) is any AE, regardless of dose, causality or expectedness, that results in death, is life-threatening, requires in-patient hospitalisation or prolongs existing in-patient hospitalisation, results in persistent or significant incapacity or disability, is a congenital anomaly or birth defect or is any other medically important event. Any ophthalmic and/or cardiac DLT is considered a medically important event and therefore an SAE in this trial. Specific AE terms are provided in the Adverse Events section |
| Primary | Number of Patients Who Experienced Non-Serious AEs | From the date of written informed consent and until 28 days after the last dose of AZD3965; an average (median) of 80 days (range: 36 to 517 days) | A non-serious AE is any untoward medical occurrence that does not meet the serious criteria described for outcome measure 3 above. Specific AE terms are provided in the Adverse Events section |
| Secondary | Area Under the Concentration-Time Curve (AUC) From 0 to 24 Hours Post AZD3965 Dosing | Part 1 (Cohorts 1-4): Day -7 (pre-dose; 0.25, 0.5, 1, 2, 4, 6, 24, 48 hours post-dose) and Day 1 (pre-dose; 0.25, 0.5, 1, 2, 4, 6, 24 hours post-dose) | Plasma samples were analysed to determine the concentrations of AZD3965 using a previously developed liquid chromatography tandem mass spectrometry (LC-MS/MS) method. For twice daily dosing, Day -7 data reflect the full daily dose but subsequent timepoints reflect half the daily dose as PK sampling was conducted up to 12 hours following the first of the two daily doses; therefore, AUC is from 0 to 12 hours at those timepoints and is reported as a separate outcome measure. |
| Secondary | AUC From 0 to 12 Hours Post AZD3965 Dosing | Part 1 (Cohorts 5-6): Day 1 (pre-dose; 0.25, 0.5, 1, 2, 4, 6, 12 hours post-dose) | Plasma samples were analysed to determine the concentrations of AZD3965 using a previously developed LC-MS/MS method. AUC from 0 to 12 hours was applicable to twice daily dosing on Day 1 only. See AUC From 0 to 24 Hours Post AZD3965 Dosing for AUC for other cohorts and timepoints. |
| Secondary | Maximum Observed Plasma Concentration of AZD3965 | Part 1 (Cohorts 1-6): Day -7 (pre-dose; 0.25, 0.5, 1, 2, 4, 6, 24, 48 hours post-dose), Day 1 & 29 (each pre-dose; 0.25, 0.5, 1, 2, 4, 6, 24 hours post-dose [12 hours post-dose if BD]); Part 2 (Expansion): Day 1 (pre-dose; 4, 6, 12 hours post-dose) | Plasma samples were analysed to determine the concentrations of AZD3965 using a previously developed LC-MS/MS method. For twice daily dosing, Day -7 data reflect the full daily dose and other timepoints reflect half the daily dose. |
| Secondary | Time to Maximum Observed Concentration of AZD3965 | Part 1 (Cohorts 1-6): Day -7 (pre-dose; 0.25, 0.5, 1, 2, 4, 6, 24, 48 hours post-dose) and Day 1 (pre-dose, 0.25, 0.5, 1, 2, 4, 6, 24 hours post-dose [12 hours post-dose if BD]) | Plasma samples were analysed to determine the concentrations of AZD3965 using a previously developed LC-MS/MS method. For twice daily dosing, Day -7 data reflect the full daily dose and other timepoints reflect half the daily dose. |
| Secondary | Elimination Half Life for AZD3965 | Part 1 (Cohorts 1-6): Day -7 (pre-dose; 0.25, 0.5, 1, 2, 4, 6, 24, 48 hours post-dose and Day 1 pre-dose (168 hours post Day -7 dose) | Plasma samples were analysed to determine the concentrations of AZD3965 using a previously developed LC-MS/MS method. |
| Secondary | Plasma Level of Cell Death Marker M30 (Caspase-Cleaved CK18; Part 1 Only) | Baseline (Day -14 to -8), Day -7 (pre-dose) Day 1 (24 hours post-dose), Day 8 (pre-dose), Day 29 (pre-dose) | Plasma samples were analysed to determine the level of M30 using a validated cell death ELISA in Part 1 (Cohorts 1-6). Assays not conducted for Part 2 of the trial as considered uninformative. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | MTD of AZD3965 | Day -7 to Day 28 | All patients recruited to dose escalation cohorts 1 to 6 who received at least one dose of AZD3965 (n=40) | mg (twice daily) | NUMBER |
| PRIMARY | Number of Patients Who Experienced DLTs | Day -7 to Day 28 | All recruited patients who received at least one dose of AZD3965 (N=51) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Patients Who Experienced Serious AEs | From the date of written informed consent and until 28 days after the last dose of AZD3965; an average (median) of 80 days (range: 36 to 517 days) | All recruited patients who received at least one dose of AZD3965 (N=51) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Patients Who Experienced Non-Serious AEs | From the date of written informed consent and until 28 days after the last dose of AZD3965; an average (median) of 80 days (range: 36 to 517 days) | All recruited patients who received at least one dose of AZD3965 (N=51) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Area Under the Concentration-Time Curve (AUC) From 0 to 24 Hours Post AZD3965 Dosing | Part 1 (Cohorts 1-4): Day -7 (pre-dose; 0.25, 0.5, 1, 2, 4, 6, 24, 48 hours post-dose) and Day 1 (pre-dose; 0.25, 0.5, 1, 2, 4, 6, 24 hours post-dose) | Part 1: Eligible patients who received AZD3965 on Day -7 and had a baseline and post-dose sample analysed (N=32; could only be calculated for N=5 in Cohort 6 \[N=6 for some PK parameters\]); Part 2: Eligible patients who received AZD3965 on Day 1 and had a baseline and post-dose sample analysed (N=11). Only calculated for Day -7 and Day 1 in Part 1 and not calculated for other timepoints due to low number of samples or for Part 2 due to limited number of sampling timepoints. | h*ng/mL | MEAN |
| SECONDARY | AUC From 0 to 12 Hours Post AZD3965 Dosing | Part 1 (Cohorts 5-6): Day 1 (pre-dose; 0.25, 0.5, 1, 2, 4, 6, 12 hours post-dose) | Part 1: Eligible patients who received AZD3965 on Day -7 and had a baseline and post-dose sample analysed (N=32; could only be calculated for N=5 in Cohort 6 \[N=6 for some PK parameters\]); Part 2: Eligible patients who received AZD3965 on Day 1 and had a baseline and post-dose sample analysed (N=11). Only calculated for Day -7 and Day 1 in Part 1 and not calculated for other timepoints due to low number of samples or for Part 2 due to limited number of sampling timepoints. | h*ng/mL | MEAN |
| SECONDARY | Maximum Observed Plasma Concentration of AZD3965 | Part 1 (Cohorts 1-6): Day -7 (pre-dose; 0.25, 0.5, 1, 2, 4, 6, 24, 48 hours post-dose), Day 1 & 29 (each pre-dose; 0.25, 0.5, 1, 2, 4, 6, 24 hours post-dose [12 hours post-dose if BD]); Part 2 (Expansion): Day 1 (pre-dose; 4, 6, 12 hours post-dose) | Part 1: Eligible patients who received AZD3965 on Day -7 and had a baseline and post-dose sample analysed (N=33) (Only limited samples were available at Day 29); Part 2: Eligible patients who received AZD3965 on Day 1 and had a baseline and post-dose sample analysed (in Part 2 of the trial, PK data were only collected for Day 1) | ng/mL | MEAN |
| SECONDARY | Time to Maximum Observed Concentration of AZD3965 | Part 1 (Cohorts 1-6): Day -7 (pre-dose; 0.25, 0.5, 1, 2, 4, 6, 24, 48 hours post-dose) and Day 1 (pre-dose, 0.25, 0.5, 1, 2, 4, 6, 24 hours post-dose [12 hours post-dose if BD]) | Part 1: Eligible patients who received AZD3965 on Day -7 and had a baseline and post-dose sample analysed (N=33); Part 2: Eligible patients who received AZD3965 on Day 1 and had a baseline and post-dose sample analysed (N=11). Only calculated for Day -7 and Day 1 in Part 1; not calculated for other timepoints due to low number of samples or for Part 2 due to number of sampling time points. One patient in Cohort 6 did not have Day -7 data (N=5). | Hour | MEDIAN |
| SECONDARY | Elimination Half Life for AZD3965 | Part 1 (Cohorts 1-6): Day -7 (pre-dose; 0.25, 0.5, 1, 2, 4, 6, 24, 48 hours post-dose and Day 1 pre-dose (168 hours post Day -7 dose) | Part 1: Eligible patients who received AZD3965 on Day -7 and had a baseline and post-dose sample analysed (N=32; one patient had a reduced dose in Cohort 6 at Day -7 so these data are not included in half life calculation). Not calculated for Part 2 due to limited number of sampling timepoints. | Hour | MEAN |
| SECONDARY | Plasma Level of Cell Death Marker M30 (Caspase-Cleaved CK18; Part 1 Only) | Baseline (Day -14 to -8), Day -7 (pre-dose) Day 1 (24 hours post-dose), Day 8 (pre-dose), Day 29 (pre-dose) | All patients in Part 1 who received AZD3965 and provided pre and post-treatment blood samples (N=37). Some patients did not have data at all timepoints | U/L | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group164
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| MTD of AZD3965 | Part 1 Dose Escalation (Cohorts 1-6) | 10 | mg (twice daily) | ||
| Number of Patients Who Experienced DLTs | AZD3965 Cohort 1 (5 mg OD) | 0 | Participants | ||
| Number of Patients Who Experienced DLTs | AZD3965 Cohort 2 (10 mg OD) | 0 | Participants | ||
| Number of Patients Who Experienced DLTs | AZD3965 Cohort 3 (20 mg OD) | 1 | Participants | ||
| Number of Patients Who Experienced DLTs | AZD3965 Cohort 4 (30 mg OD) | 1 | Participants | ||
| Number of Patients Who Experienced DLTs | AZD3965 Cohort 5 (15 mg BD) | 3 | Participants | ||
| Number of Patients Who Experienced DLTs | AZD3965 Cohort 6 (10 mg BD) | 2 | Participants | ||
| Number of Patients Who Experienced DLTs | AZD3965 Expansion Cohort (10 mg BD) | 1 | Participants | ||
| Number of Patients Who Experienced Serious AEs | AZD3965 Cohort 1 (5 mg OD) | 1 | Participants | ||
| Number of Patients Who Experienced Serious AEs | AZD3965 Cohort 2 (10 mg OD) | 1 | Participants |
1 to 10 of 164Source ClinicalTrials.gov
See all 164 results by groupParticipant flow147
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 AZD3965 Cohort 1 (5 mg OD) | STARTED | AZD3965 Cohort 1 (5 mg OD) | 3 | |
| Part 1 AZD3965 Cohort 1 (5 mg OD) | STARTED | AZD3965 Cohort 2 (10 mg OD) | 0 | |
| Part 1 AZD3965 Cohort 1 (5 mg OD) | STARTED | AZD3965 Cohort 3 (20 mg OD) | 0 | |
| Part 1 AZD3965 Cohort 1 (5 mg OD) | STARTED | AZD3965 Cohort 4 (30 mg OD) | 0 | |
| Part 1 AZD3965 Cohort 1 (5 mg OD) | STARTED | AZD3965 Cohort 5 (15 mg BD) | 0 | |
| Part 1 AZD3965 Cohort 1 (5 mg OD) | STARTED | AZD3965 Cohort 6 (10 mg BD) | 0 | |
| Part 1 AZD3965 Cohort 1 (5 mg OD) | STARTED | AZD3965 Expansion Cohort (10 mg BD) | 0 | |
| Part 1 AZD3965 Cohort 1 (5 mg OD) | COMPLETED | AZD3965 Cohort 1 (5 mg OD) | 0 | |
| Part 1 AZD3965 Cohort 1 (5 mg OD) | COMPLETED | AZD3965 Cohort 2 (10 mg OD) | 0 | |
| Part 1 AZD3965 Cohort 1 (5 mg OD) | COMPLETED | AZD3965 Cohort 3 (20 mg OD) | 0 |
1 to 10 of 147Source ClinicalTrials.gov
See all 147 participant flowAdverse events1,358
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 | Abdominal discomfort | Gastrointestinal disorders | AZD3965 Cohort 1 (5 mg OD) | 0 | 3 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | AZD3965 Cohort 2 (10 mg OD) | 0 | 5 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | AZD3965 Cohort 3 (20 mg OD) | 0 | 8 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | AZD3965 Cohort 4 (30 mg OD) | 0 | 5 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | AZD3965 Cohort 5 (15 mg BD) | 0 | 11 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | AZD3965 Cohort 6 (10 mg BD) | 0 | 8 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | AZD3965 Expansion Cohort (10 mg BD) | 1 | 11 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | AZD3965 Cohort 1 (5 mg OD) | 1 | 3 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | AZD3965 Cohort 2 (10 mg OD) | 3 | 5 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | AZD3965 Cohort 3 (20 mg OD) | 1 | 8 | 1 |
1 to 10 of 1,358Source ClinicalTrials.gov
See all 1,358 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AZD3965 Cohort 1 (5 mg OD) | 1 | 3 |
| Total, all-cause mortality | AZD3965 Cohort 2 (10 mg OD) | 1 | 5 |
| Total, all-cause mortality | AZD3965 Cohort 3 (20 mg OD) | 0 | 8 |
| Total, all-cause mortality | AZD3965 Cohort 4 (30 mg OD) | 0 | 5 |
| Total, all-cause mortality | AZD3965 Cohort 5 (15 mg BD) | 0 | 11 |
| Total, all-cause mortality | AZD3965 Cohort 6 (10 mg BD) | 0 | 8 |
| Total, all-cause mortality | AZD3965 Expansion Cohort (10 mg BD) | 0 | 11 |
| Total, other adverse events | AZD3965 Cohort 1 (5 mg OD) | 3 | 3 |
| Total, other adverse events | AZD3965 Cohort 2 (10 mg OD) | 5 | 5 |
| Total, other adverse events | AZD3965 Cohort 3 (20 mg OD) | 7 | 8 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
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.
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.
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