Trial · NCT04145700
CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Synovial Sarcoma
NCT04145700, Phase 1, Phase 2, Terminated, Eli Lilly and Company; results first posted 2023-09-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Synovial Sarcoma. Trials, record NCT04145700. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04145700
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Synovial Sarcoma
- NCT number
- NCT04145700
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Synovial Sarcoma
- Interventions
- Ramucirumab, Gemcitabine, Docetaxel
- First posted
- 2019-10-31
- Last updated
- 2023-09-13
- Other registries' IDs
- eudract:2018-004243-23
- Results first posted
- 2023-09-13
- Limitations and caveats
The limitation to this study was the highly varied estimates of the PFS HR and the probability of PFS HR \< 1 due to influence from the matched historical controls whose PFS substantially outperformed PFS from the prospectively randomized control.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | Baseline to Objective Progression or Death Due to Any Cause (Up To 6.4 Months) | PFS is defined as the time from randomization until the first investigator-determined objective progression as defined by Response Evaluation Criteria In Solid Tumors, Version 1.1 (RECIST v1.1) or death from any cause in the absence of progressive disease. Participants known to be alive and without disease progression will be censored at the time of the last adequate tumor assessment or date of randomization, whichever is later. |
| Secondary | Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) | Baseline through Measured Progressive Disease (Up To 6.4 Months) | ORR is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. |
| Secondary | Duration of Response (DoR) | Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 4.13 Months) | DoR is defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective disease progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of documented disease progression or recurrence. |
| Secondary | Complete Response (CR): Percentage of Participants Who Achieve CR | Baseline Up to 6.94 months | CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. |
| Secondary | Pharmacokinetics (PK): Maximum Serum Concentration of Ramucirumab (Cmax) | 0.5 hours after the end of ramucirumab infusion on Day 1 of Cycle 1 | Cmax was the concentration of study drug in the blood after the dose is administered. It was measured post-dose and was summarized using descriptive statistics. |
| Secondary | PK: Minimum Serum Concentration of Ramucirumab (Cmin) | Prior to ramucirumab infusion on Day 8 of Cycle 1, Day 1 of Cycle 2 and Day 1 of Cycle 5 | Cmin was the concentration of study drug in the blood immediately before the next dose was administered. It was measured pre-dose at all visits and was summarized using descriptive statistics. |
| Secondary | Number of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADA) | Baseline Up to 6.94 months | A TE-ADA evaluable participant is considered to be TE-ADA positive if the participant has at least one post baseline titer that is a 4-fold or greater increase in titer from baseline measurement (treatment-boosted). If baseline result is ADA Not Present, then the participant is TE ADA positive if there is at least one post baseline result of ADA Present with titer \>= 20 (treatment-induced). |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) | Baseline to Objective Progression or Death Due to Any Cause (Up To 6.4 Months) | All randomized participants (including the censored participants). Number of participants censored in Ramucirumab + Gemcitabine + Docetaxel=4, Gemcitabine + Docetaxel=2. | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) | Baseline through Measured Progressive Disease (Up To 6.4 Months) | All randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DoR) | Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 4.13 Months) | All randomized participants who had CR or PR responses. For Gemcitabine + Docetaxel, there were no participants with CR or PR responses to evaluate DoR, hence, zero participants analysed. | Months | NUMBER |
| SECONDARY | Complete Response (CR): Percentage of Participants Who Achieve CR | Baseline Up to 6.94 months | All randomized participants. | Percentage of participants | NUMBER |
| SECONDARY | Pharmacokinetics (PK): Maximum Serum Concentration of Ramucirumab (Cmax) | 0.5 hours after the end of ramucirumab infusion on Day 1 of Cycle 1 | All randomized participants who received at least one dose of Ramucirumab and had evaluable PK data. | microgram per milliliter (µg/mL) | GEOMETRIC_MEAN |
| SECONDARY | PK: Minimum Serum Concentration of Ramucirumab (Cmin) | Prior to ramucirumab infusion on Day 8 of Cycle 1, Day 1 of Cycle 2 and Day 1 of Cycle 5 | All randomized participants who received at least one dose of Ramucirumab and had evaluable PK data. | microgram per milliliter (µg/mL) | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADA) | Baseline Up to 6.94 months | All randomized participants who received at least one dose of study drug and had at least one non-missing baseline, post baseline ADA value. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) | Ramucirumab + Gemcitabine + Docetaxel | 2.10 | 80% Confidence Interval 2 to 6 | Months | |
| Progression Free Survival (PFS) | Gemcitabine + Docetaxel | 2.03 | 80% Confidence Interval 1.38 to NA | Months | |
| Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) | Ramucirumab + Gemcitabine + Docetaxel | 6.3 | 80% Confidence Interval 0.7 to 22.2 | Percentage of participants | |
| Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) | Gemcitabine + Docetaxel | 0 | 80% Confidence Interval 0 to 28 | Percentage of participants | |
| Duration of Response (DoR) | Ramucirumab + Gemcitabine + Docetaxel | NA | Months | ||
| Complete Response (CR): Percentage of Participants Who Achieve CR | Ramucirumab + Gemcitabine + Docetaxel | 0 | 80% Confidence Interval 0 to 13.4 | Percentage of participants | |
| Complete Response (CR): Percentage of Participants Who Achieve CR | Gemcitabine + Docetaxel | 0 | 80% Confidence Interval 0 to 28 | Percentage of participants | |
| Pharmacokinetics (PK): Maximum Serum Concentration of Ramucirumab (Cmax) | Ramucirumab + Gemcitabine + Docetaxel | 231 | Geometric Coefficient of Variation 43 | microgram per milliliter (µg/mL) | |
| PK: Minimum Serum Concentration of Ramucirumab (Cmin) | Ramucirumab + Gemcitabine + Docetaxel | Day 8 of Cycle 1 | 73.3 | Geometric Coefficient of Variation 39 | microgram per milliliter (µg/mL) |
| PK: Minimum Serum Concentration of Ramucirumab (Cmin) | Ramucirumab + Gemcitabine + Docetaxel | Day 1 of Cycle 2 | 55.4 | Geometric Coefficient of Variation 24 | microgram per milliliter (µg/mL) |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ramucirumab + Gemcitabine + Docetaxel | 16 | |
| Overall Study | STARTED | Gemcitabine + Docetaxel | 7 | |
| Overall Study | Received at Least One Dose of Study Drug | Ramucirumab + Gemcitabine + Docetaxel | 16 | |
| Overall Study | Received at Least One Dose of Study Drug | Gemcitabine + Docetaxel | 6 | |
| Overall Study | COMPLETED | Ramucirumab + Gemcitabine + Docetaxel | 8 | |
| Overall Study | COMPLETED | Gemcitabine + Docetaxel | 4 | |
| Overall Study | NOT COMPLETED | Ramucirumab + Gemcitabine + Docetaxel | 8 | |
| Overall Study | NOT COMPLETED | Gemcitabine + Docetaxel | 3 |
Source ClinicalTrials.gov
Adverse events246
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 | Anaemia | Blood and lymphatic system disorders | Ramucirumab + Gemcitabine + Docetaxel | 7 | 16 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | Gemcitabine + Docetaxel | 2 | 6 | 4 |
| other | Leukopenia | Blood and lymphatic system disorders | Ramucirumab + Gemcitabine + Docetaxel | 1 | 16 | 1 |
| other | Leukopenia | Blood and lymphatic system disorders | Gemcitabine + Docetaxel | 0 | 6 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Ramucirumab + Gemcitabine + Docetaxel | 5 | 16 | 11 |
| other | Neutropenia | Blood and lymphatic system disorders | Gemcitabine + Docetaxel | 1 | 6 | 4 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ramucirumab + Gemcitabine + Docetaxel | 1 | 16 | 2 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Gemcitabine + Docetaxel | 0 | 6 | 0 |
| other | Sinus tachycardia | Cardiac disorders | Ramucirumab + Gemcitabine + Docetaxel | 1 | 16 | 2 |
| other | Sinus tachycardia | Cardiac disorders | Gemcitabine + Docetaxel | 0 | 6 | 0 |
1 to 10 of 246Source ClinicalTrials.gov
See all 246 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ramucirumab + Gemcitabine + Docetaxel | 8 | 16 |
| Total, all-cause mortality | Gemcitabine + Docetaxel | 4 | 6 |
| Total, other adverse events | Ramucirumab + Gemcitabine + Docetaxel | 15 | 16 |
| Total, other adverse events | Gemcitabine + Docetaxel | 6 | 6 |
| Total, serious adverse events | Ramucirumab + Gemcitabine + Docetaxel | 8 | 16 |
| Total, serious adverse events | Gemcitabine + Docetaxel | 2 | 6 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ramucirumab + Gemcitabine + Docetaxel vs Gemcitabine + Docetaxel: deaths from any cause | Trial comparisons |
| Ramucirumab + Gemcitabine + Docetaxel vs Gemcitabine + Docetaxel: Number of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADA) | Trial comparisons |
| Ramucirumab + Gemcitabine + Docetaxel vs Gemcitabine + Docetaxel: serious adverse events | Trial comparisons |
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/NCT04145700
GET https://conductscience.org/api/trials/v1/NCT04145700/events?page=2