Trial · NCT03930771
Capecitabine and Temozolomide for Treatment of Recurrent Pituitary Adenomas
NCT03930771, Phase 2, Terminated, Weill Medical College of Cornell University; results first posted 2022-08-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Capecitabine and Temozolomide for Treatment of Recurrent Pituitary Adenomas. Trials, record NCT03930771. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03930771
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Capecitabine and Temozolomide for Treatment of Recurrent Pituitary Adenomas
- NCT number
- NCT03930771
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- Weill Medical College of Cornell University
- Conditions
- Recurrent Pituitary Adenomas
- Interventions
- Capecitabine, Temozolomide
- First posted
- 2019-04-29
- Last updated
- 2022-08-09
- Results first posted
- 2022-08-09
- Limitations and caveats
- Due to lower accrual (N=1), there was insufficient data available in order to meet the primary and secondary outcome measures.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Radiographic Response, as Defined by the RECIST Criteria. | 6 months | Evaluation of Target lesions: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum onstudy (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Secondary | Effect of the CAP and TMZ Combination on Pituitary Function, Measured by Changes in Pituitary Hormone Secretion in Patients | At baseline and every 8 weeks, up to 6 months | Serum prolactin, IGF-1, ACTH, FSH, LH and TSH levels are used to assess changes in pituitary hormone function. These tests will only be repeated if found to be abnormal at baseline. |
| Secondary | Safety, as Measured by the Number of Subjects With at Least One AE | 6 months | |
| Secondary | Tolerability of the TMZ and Capecitabine Combination, as Measured by Number of Participants With a Dose-limiting Toxicity | 6 months | |
| Secondary | Tumor Invasiveness and Aggressiveness, Determined by Assessing the Relationship Between Select Indicators With Response to Chemotherapy, Time to Progression, and Tumor Invasiveness. | 6 months | Tumor invasiveness and aggressiveness, determined by assessing the relationship between select indicators (including Ki67 nuclear labelling index, p53 expression, MGMT expression/methylation status, and additional tumor genetic profiling) with response to chemotherapy, time to progression, and tumor invasiveness (based on the Knosp criteria). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Radiographic Response, as Defined by the RECIST Criteria. | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Effect of the CAP and TMZ Combination on Pituitary Function, Measured by Changes in Pituitary Hormone Secretion in Patients | At baseline and every 8 weeks, up to 6 months | ng/mL | NUMBER | |
| SECONDARY | Safety, as Measured by the Number of Subjects With at Least One AE | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Tolerability of the TMZ and Capecitabine Combination, as Measured by Number of Participants With a Dose-limiting Toxicity | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Tumor Invasiveness and Aggressiveness, Determined by Assessing the Relationship Between Select Indicators With Response to Chemotherapy, Time to Progression, and Tumor Invasiveness. | 6 months | Data was not collected in the specified time frame for this outcome measure. |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Radiographic Response, as Defined by the RECIST Criteria. | All Patients | 0 | Participants | ||
| Effect of the CAP and TMZ Combination on Pituitary Function, Measured by Changes in Pituitary Hormone Secretion in Patients | All Patients | Baseline | 134.7 | ng/mL | |
| Effect of the CAP and TMZ Combination on Pituitary Function, Measured by Changes in Pituitary Hormone Secretion in Patients | All Patients | Cycle 3 Day 1 | 86.9 | ng/mL | |
| Effect of the CAP and TMZ Combination on Pituitary Function, Measured by Changes in Pituitary Hormone Secretion in Patients | All Patients | Cycle 5 Day 1 | 69.4 | ng/mL | |
| Effect of the CAP and TMZ Combination on Pituitary Function, Measured by Changes in Pituitary Hormone Secretion in Patients | All Patients | Cycle 6 Day 1 | 69.8 | ng/mL | |
| Effect of the CAP and TMZ Combination on Pituitary Function, Measured by Changes in Pituitary Hormone Secretion in Patients | All Patients | End of Treatment | 80.1 | ng/mL | |
| Effect of the CAP and TMZ Combination on Pituitary Function, Measured by Changes in Pituitary Hormone Secretion in Patients | All Patients | Follow-Up Week 6 | 77.0 | ng/mL | |
| Safety, as Measured by the Number of Subjects With at Least One AE | All Patients | 1 | Participants | ||
| Tolerability of the TMZ and Capecitabine Combination, as Measured by Number of Participants With a Dose-limiting Toxicity | All Patients | 1 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Patients | 1 | |
| Overall Study | COMPLETED | All Patients | 1 | |
| Overall Study | NOT COMPLETED | All Patients | 0 |
Source ClinicalTrials.gov
Adverse events4
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 | Fatigue | General disorders | All Patients | 1 | 1 | |
| other | Paresthesia | Nervous system disorders | All Patients | 1 | 1 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | All Patients | 1 | 1 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | All Patients | 1 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Patients | 0 | 1 |
| Total, other adverse events | All Patients | 1 | 1 |
| Total, serious adverse events | All Patients | 0 | 1 |
Source ClinicalTrials.gov
Papers0
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/NCT03930771
GET https://conductscience.org/api/trials/v1/NCT03930771/registered