Trial · NCT01260688
Cediranib Maleate With or Without Dasatinib in Patients With HRPC-Resistant to Treatment With Docetaxel
NCT01260688, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2013-12-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cediranib Maleate With or Without Dasatinib in Patients With HRPC-Resistant to Treatment With Docetaxel. Trials, record NCT01260688. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01260688
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cediranib Maleate With or Without Dasatinib in Patients With HRPC-Resistant to Treatment With Docetaxel
- NCT number
- NCT01260688
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Hormone Refractory Prostate Cancer, Recurrent Prostate Cancer
- Interventions
- cediranib maleate, dasatinib
- First posted
- 2010-12-15
- Last updated
- 2018-08-08
- Results first posted
- 2013-12-05
- Limitations and caveats
- Clinical development discontinuation of Cediranib leading to small numbers of subjects analyzed.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 12-week Progression-free Survival as Per the Prostate Cancer Clinical Trials Working Group (PCWG2) | 3 months | Progression is defined using the Prostate Cancer Clinical Trials Working Group (PCWG2) criteria, which includes a compilation of prostate-specific antigen (PSA), bone scan, and CT-scan assessments (Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Number of Participants With Toxicities | Up to 30 days after last dose of study drugs | Incidence of toxicities graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v4.0 |
| Secondary | Qualtiy of Life Assessment Number of Participants With a Score ≥2 on the Present Pain Intensity (PPI) Scale | After every cycle (median duration on study = 4 cycles) | Present Pain Intensity (PPI) scale. Scale is measured 0-5, where 0=no pain, 1=mild pain, 2=discomforting pain, 3=distressing pain, 4=horrible pain and 5=excruciating pain Participants who were up to completing the assessment (did not decline) and who reported a score \>=2 at the end of any cycle are reported. |
| Secondary | Number Who Experienced Study Medication Dose Intensity | Cycle 1 (an average of 28 days) | Number of patients who experienced study medication dose of over 80% during Cycle 1 was assessed. |
| Secondary | Treatment Discontinuation | Cycle 1 (average of 28 days) | Discontinuation of treatment in cycle 1 (average of 28 days) |
| Secondary | Treatment Discontinuation Due to Adverse Events (AEs) | Through study completion (median duration on study = 4 cycles) | Treatment discontinuation due to Adverse Events |
| Secondary | Non-AE Related Treatment Discontinuation | Through study completion (median duration on study = 4 cycles) | Non-Adverse Event related Treatment Discontinuation |
| Secondary | Overall Response Rate | Duration of Study (median duration on study = 4 cycles) | Best overall response rate of each evaluable patient |
| Secondary | Treatment Related Deaths | Through study completion (median duration on study = 4 cycles) | Number of treatment related deaths |
| Secondary | Participants for Which Bone Biomarkers for Beta-C Telopeptide Was Reduced | Through study completion (median duration on study = 4 cycles) | Participants for which beta-C telopeptide was reduced |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 12-week Progression-free Survival as Per the Prostate Cancer Clinical Trials Working Group (PCWG2) | 3 months | All patients were included in the analysis for 12-week PFS. | participants | NUMBER |
| SECONDARY | Number of Participants With Toxicities | Up to 30 days after last dose of study drugs | participants | NUMBER | |
| SECONDARY | Qualtiy of Life Assessment Number of Participants With a Score ≥2 on the Present Pain Intensity (PPI) Scale | After every cycle (median duration on study = 4 cycles) | Analysis was performed patients receiving single agent cediranib or combination of cediranib plus dasatinib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number Who Experienced Study Medication Dose Intensity | Cycle 1 (an average of 28 days) | participant | NUMBER | |
| SECONDARY | Treatment Discontinuation | Cycle 1 (average of 28 days) | Analysis was performed on study participants enrolled on the trial assessing number of patients who discontinued treatment in cycle 1. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Treatment Discontinuation Due to Adverse Events (AEs) | Through study completion (median duration on study = 4 cycles) | participants | NUMBER | |
| SECONDARY | Non-AE Related Treatment Discontinuation | Through study completion (median duration on study = 4 cycles) | participants | NUMBER | |
| SECONDARY | Overall Response Rate | Duration of Study (median duration on study = 4 cycles) | months | MEDIAN | |
| SECONDARY | Treatment Related Deaths | Through study completion (median duration on study = 4 cycles) | In Arm II (Cediranib alone), 1 patient presented retroperitoneal hemorrhage (Grade 5). | participants | NUMBER |
| SECONDARY | Participants for Which Bone Biomarkers for Beta-C Telopeptide Was Reduced | Through study completion (median duration on study = 4 cycles) | Analysis was done on study participatns for which beta-C telopeptide was reduced. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 12-week Progression-free Survival as Per the Prostate Cancer Clinical Trials Working Group (PCWG2) | Arm I - Cediranib Plus Dasatinib | 2 | participants | ||
| 12-week Progression-free Survival as Per the Prostate Cancer Clinical Trials Working Group (PCWG2) | Arm II - Cediranib Alone | 8 | participants | ||
| Number of Participants With Toxicities | Arm I - Cediranib Plus Dasatinib | 11 | participants | ||
| Number of Participants With Toxicities | Arm II - Cediranib Alone | 11 | participants | ||
| Qualtiy of Life Assessment Number of Participants With a Score ≥2 on the Present Pain Intensity (PPI) Scale | Arm I - Cediranib Plus Dasatinib | 4 | Participants | ||
| Qualtiy of Life Assessment Number of Participants With a Score ≥2 on the Present Pain Intensity (PPI) Scale | Arm II - Cediranib Alone | 8 | Participants | ||
| Number Who Experienced Study Medication Dose Intensity | Arm I - Cediranib Plus Dasatinib | 6 | participant | ||
| Number Who Experienced Study Medication Dose Intensity | Arm II - Cediranib Alone | 9 | participant | ||
| Treatment Discontinuation | Arm I - Cediranib Plus Dasatinib | 7 | Participants | ||
| Treatment Discontinuation | Arm II - Cediranib Alone | 6 | Participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I - Cediranib Plus Dasatinib | 11 | |
| Overall Study | STARTED | Arm II - Cediranib Alone | 11 | |
| Overall Study | COMPLETED | Arm I - Cediranib Plus Dasatinib | 11 | |
| Overall Study | COMPLETED | Arm II - Cediranib Alone | 11 | |
| Overall Study | NOT COMPLETED | Arm I - Cediranib Plus Dasatinib | 0 | |
| Overall Study | NOT COMPLETED | Arm II - Cediranib Alone | 0 |
Source ClinicalTrials.gov
Adverse events308
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 | Hypertension | Vascular disorders | Arm I - Cediranib Plus Dasatinib | 9 | 11 | |
| other | Hypertension | Vascular disorders | Arm II - Cediranib Alone | 11 | 11 | |
| other | Anemia | Blood and lymphatic system disorders | Arm I - Cediranib Plus Dasatinib | 11 | 11 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II - Cediranib Alone | 11 | 11 | |
| other | Diarrhea | Gastrointestinal disorders | Arm I - Cediranib Plus Dasatinib | 8 | 11 | |
| other | Diarrhea | Gastrointestinal disorders | Arm II - Cediranib Alone | 7 | 11 | |
| other | Fatigue | General disorders | Arm I - Cediranib Plus Dasatinib | 11 | 11 | |
| other | Fatigue | General disorders | Arm II - Cediranib Alone | 9 | 11 | |
| other | Alkaline Phosphatase Increased | Investigations | Arm I - Cediranib Plus Dasatinib | 8 | 11 | |
| other | Alkaline Phosphatase Increased | Investigations | Arm II - Cediranib Alone | 10 | 11 |
1 to 10 of 308Source ClinicalTrials.gov
See all 308 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I - Cediranib Plus Dasatinib | ||
| Total, all-cause mortality | Arm II - Cediranib Alone | ||
| Total, other adverse events | Arm I - Cediranib Plus Dasatinib | 11 | 11 |
| Total, other adverse events | Arm II - Cediranib Alone | 11 | 11 |
| Total, serious adverse events | Arm I - Cediranib Plus Dasatinib | 5 | 11 |
| Total, serious adverse events | Arm II - Cediranib Alone | 7 | 11 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24788563 | DERIVED |
Source PubMed
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| U01CA070095 | Phase I Clinical Trials of New Anti-Cancer Targeted Therapies | CARDUCCI, MICHAEL A | JOHNS HOPKINS UNIVERSITY | NATIONAL CANCER INSTITUTE | 1995 to 2013 | NIH RePORTER |
| U01CA132123 | Princess Margaret Hospital Phase I Consortium | SIU, LILLIAN L | UNIVERSITY HEALTH NETWORK | NATIONAL CANCER INSTITUTE | 2008 to 2013 | NIH RePORTER |
Trial comparisons11
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I - Cediranib Plus Dasatinib vs Arm II - Cediranib Alone: Treatment Related Deaths | Trial comparisons |
| Arm I - Cediranib Plus Dasatinib vs Arm II - Cediranib Alone: Treatment Discontinuation Due to Adverse Events (AEs) | Trial comparisons |
| Arm I - Cediranib Plus Dasatinib vs Arm II - Cediranib Alone: Dose Reductions | Trial comparisons |
| Arm I - Cediranib Plus Dasatinib vs Arm II - Cediranib Alone: 12-week Progression-free Survival as Per the Prostate Cancer Clinical Trials Working Group (PCWG2) | Trial comparisons |
| Arm I - Cediranib Plus Dasatinib vs Arm II - Cediranib Alone: Dose Interruption Due to AEs | Trial comparisons |
| Arm I - Cediranib Plus Dasatinib vs Arm II - Cediranib Alone: Qualtiy of Life Assessment Number of Participants With a Score ≥2 on the Present Pain Intensity (PPI) Scale | Trial comparisons |
| Arm I - Cediranib Plus Dasatinib vs Arm II - Cediranib Alone: Participants for Which Bone Biomarkers for Beta-C Telopeptide Was Reduced | Trial comparisons |
| Arm I - Cediranib Plus Dasatinib vs Arm II - Cediranib Alone: Treatment Discontinuation | Trial comparisons |
| Arm I - Cediranib Plus Dasatinib vs Arm II - Cediranib Alone: Number of Participants With Toxicities | Trial comparisons |
| Arm I - Cediranib Plus Dasatinib vs Arm II - Cediranib Alone: Number of Participants With Increased Alkaline Phosphatase BAP | Trial comparisons |
1 to 10 of 11
See all 11 trial comparisonsTests0
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/NCT01260688
GET https://conductscience.org/api/trials/v1/NCT01260688/results?page=2