Trial · NCT01588548
Global Phase1 Study to Assess the Safety and Tolerability of AZD1208 in Advanced Solid Tumors and Malignant Lymphoma
NCT01588548, Phase 1, Completed, AstraZeneca; results first posted 2015-08-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Global Phase1 Study to Assess the Safety and Tolerability of AZD1208 in Advanced Solid Tumors and Malignant Lymphoma. Trials, record NCT01588548. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01588548
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Global Phase1 Study to Assess the Safety and Tolerability of AZD1208 in Advanced Solid Tumors and Malignant Lymphoma
- NCT number
- NCT01588548
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 43 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Advanced Solid Malignancies, Malignant Lymphoma
- Interventions
- AZD1208
- First posted
- 2012-05-01
- Last updated
- 2015-11-04
- Results first posted
- 2015-08-19
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria) | Measurements occur at screening (<=28 days before start of study treatment), every 6 weeks (+/-1 week) up to 12 weeks and then every 12 weeks (+/-1 week) until discontinuation of study treatment or withdrawal of consent, starting from Day 1 of Cycle 1 | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions (TL)s since baseline and any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10 mm; Partial Response (PR), at least a 30% decrease in the sum of diameters of TLs; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease (PD), at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm; Not Evaluable (NE), this is only relevant if any of the TLs were not assessed or not evaluable or had a lesion intervention at this visit, also note that if the sum of diameters meets the progressive disease criteria, progressive disease overrides not evaluable as a TL response. Best objective response is the best response a patient experiences over the randomised treatment period. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria) | Measurements occur at screening (<=28 days before start of study treatment), every 6 weeks (+/-1 week) up to 12 weeks and then every 12 weeks (+/-1 week) until discontinuation of study treatment or withdrawal of consent, starting from Day 1 of Cycle 1 | All patients who were evaluable for Response analysis set for RECIST criteria | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria) | AZD1208 120mg | CR | 0 | Participants | |
| Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria) | AZD1208 240mg | CR | 0 | Participants | |
| Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria) | AZD1208 360mg | CR | 0 | Participants | |
| Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria) | AZD1208 540mg | CR | 0 | Participants | |
| Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria) | AZD1208 700mg | CR | 0 | Participants | |
| Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria) | AZD1208 800mg | CR | 0 | Participants | |
| Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria) | AZD1208 120mg | PR | 0 | Participants | |
| Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria) | AZD1208 240mg | PR | 0 | Participants | |
| Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria) | AZD1208 360mg | PR | 0 | Participants | |
| Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria) | AZD1208 540mg | PR | 0 | Participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AZD1208 120mg | 3 | |
| Overall Study | STARTED | AZD1208 240mg | 7 | |
| Overall Study | STARTED | AZD1208 360mg | 6 | |
| Overall Study | STARTED | AZD1208 540mg | 7 | |
| Overall Study | STARTED | AZD1208 700mg | 6 | |
| Overall Study | STARTED | AZD1208 800mg | 6 | |
| Overall Study | Cycle 1 Day 21 | AZD1208 120mg | 3 | |
| Overall Study | Cycle 1 Day 21 | AZD1208 240mg | 5 | |
| Overall Study | Cycle 1 Day 21 | AZD1208 360mg | 2 | |
| Overall Study | Cycle 1 Day 21 | AZD1208 540mg | 5 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events840
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 | Urinary Tract Infection | Infections and infestations | AZD1208 120mg | 0 | 3 | |
| other | Urinary Tract Infection | Infections and infestations | AZD1208 240mg | 1 | 7 | |
| other | Urinary Tract Infection | Infections and infestations | AZD1208 360mg | 1 | 6 | |
| other | Urinary Tract Infection | Infections and infestations | AZD1208 540mg | 1 | 7 | |
| other | Urinary Tract Infection | Infections and infestations | AZD1208 700mg | 0 | 6 | |
| other | Urinary Tract Infection | Infections and infestations | AZD1208 800mg | 0 | 6 | |
| other | Oral Candidiasis | Infections and infestations | AZD1208 120mg | 0 | 3 | |
| other | Oral Candidiasis | Infections and infestations | AZD1208 240mg | 0 | 7 | |
| other | Oral Candidiasis | Infections and infestations | AZD1208 360mg | 0 | 6 | |
| other | Oral Candidiasis | Infections and infestations | AZD1208 540mg | 0 | 7 |
1 to 10 of 840Source ClinicalTrials.gov
See all 840 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AZD1208 120mg | ||
| Total, all-cause mortality | AZD1208 240mg | ||
| Total, all-cause mortality | AZD1208 360mg | ||
| Total, all-cause mortality | AZD1208 540mg | ||
| Total, all-cause mortality | AZD1208 700mg | ||
| Total, all-cause mortality | AZD1208 800mg | ||
| Total, other adverse events | AZD1208 120mg | 3 | 3 |
| Total, other adverse events | AZD1208 240mg | 7 | 7 |
| Total, other adverse events | AZD1208 360mg | 6 | 6 |
| Total, other adverse events | AZD1208 540mg | 7 | 7 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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/NCT01588548
GET https://conductscience.org/api/trials/v1/NCT01588548/results?page=2