Trial · NCT05010629
9-ING-41 Plus Carboplatin in Salivary Gland Carcinoma
NCT05010629, Phase 2, Active not recruiting, Robert Haddad, MD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 9-ING-41 Plus Carboplatin in Salivary Gland Carcinoma. Trials, record NCT05010629. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05010629
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 9-ING-41 Plus Carboplatin in Salivary Gland Carcinoma
- NCT number
- NCT05010629
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 32 participants, actual
- Lead sponsor
- Robert Haddad, MD
- Conditions
- Salivary Gland Cancer, Recurrent Salivary Gland Cancer, Metastatic Cancer, Adenoid Cystic Carcinoma
- Interventions
- 9-ING-41, Carboplatin, Pembrolizumab
- First posted
- 2021-08-18
- Last updated
- 2026-10-23
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Tumor assessments were performed every 3 cycles (each cycle was 21 days), for up to 15.6 months. | ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. |
| Secondary | Median Progression Free Survival (PFS) | Tumor assessments were performed every 9 weeks for up to 20.2 months. | PFS based on Kaplan-Meier is defined as the time from registration to the earlier of progressive disease (PD) or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated. |
| Secondary | Median Overall Survival (OS) | Up to 38.1 months | Overall survival based on the Kaplan-Meier method is defined as the time from randomization to death. Participants alive are censored at the last date of contact (including lost-to-follow-up) or at the date of withdrawal of consent, if relevant. |
| Secondary | Duration of Response (DOR) | Tumor assessments were performed every 3 cycles (each cycle was 21 days), for up to 15.6 months. | DOR is defined as the time from date of first documented confirmed objective response to date of first documented progressive disease (PD). Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated. |
| Secondary | Number of Participants With Treatment Related Adverse Events (AE) | AEs were assessed at Day 1 and Day 4 of each 21-day treatment cycle; assessed for up to 16.6 months. | Number of participants with treatment-related AE is defined as the number of participants who experienced at least one AE assessed as possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. |
| Secondary | Mean Score of Global Question 1 in University of Washington Quality of Life Questionnaire (UW-QOL) | Baseline and off-treatment (end-of-treatment) assessment; maximum treatment duration was 15.6 months. | UW-QOL Global Question 1 assessed how participants felt relative to before they developed their cancer. The mean score was calculated among all participants who provided a response to this question. Responses were recorded on a 5-point ordinal scale and transformed to a 0-100 score, where 0 = Much worse, 25 = Somewhat worse, 50 = About the same, 75 = Somewhat better, and 100 = Much better. |
| Secondary | Mean Score of Global Question 2 in UW-QOL | Baseline and off-treatment (end-of-treatment) assessment; maximum treatment duration was 15.6 months. | UW-QOL Global Question 2 assessed patients' health-related QOL during the past 7 days. The mean score was calculated among all participants who provided a response to this question. Responses were recorded on a 6-point ordinal scale and transformed to a 0-100 score, where 0 = Very Poor, 20 = Poor, 40 = Fair, 60 = Good, 80 = Very Good, and 100 = Outstanding. |
| Secondary | Mean Score of Global Question 3 in UW-QOL | Baseline and off-treatment (end-of-treatment) assessment; maximum treatment duration was 15.6 months. | UW-QOL Global Question 3 assessed patients' overall QOL during the past 7 days. The mean score was calculated among all participants who provided a response to this question. Responses were recorded on a 6-point ordinal scale and transformed to a 0-100 score, where 0 = Very Poor, 20 = Poor, 40 = Fair, 60 = Good, 80 = Very Good, and 100 = Outstanding. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT05010629
GET https://conductscience.org/api/trials/v1/NCT05010629/registered