Trial · NCT01688973
Tivantinib With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Locally Advanced Kidney Cancer That Cannot Be Removed by Surgery
NCT01688973, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2019-01-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tivantinib With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Locally Advanced Kidney Cancer That Cannot Be Removed by Surgery. Trials, record NCT01688973. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01688973
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tivantinib With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Locally Advanced Kidney Cancer That Cannot Be Removed by Surgery
- NCT number
- NCT01688973
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 55 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Renal Cell Carcinoma, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer, Type 1 Papillary Renal Cell Carcinoma, Type 2 Papillary Renal Cell Carcinoma
- Interventions
- Erlotinib Hydrochloride, Laboratory Biomarker Analysis, Tivantinib
- First posted
- 2012-09-20
- Last updated
- 2019-01-03
- Results first posted
- 2019-01-03
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid Tumors | Up to 3 years | Best Response is calculated from the sequence of objective statuses. CR: Two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. PR: Two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration, but not qualifying as CR. Stable/no response: At least one objective status of stable/no response documented at least 6 weeks after registration and before progression or symptomatic deterioration, but not qualifying as anything else above. Increasing disease: Objective status of progression within 12 weeks of registration, not qualifying as anything else above. Symptomatic deterioration: Objective status of symptomatic deterioration within 12 weeks of registration, not qualifying as anything else above. |
| Secondary | Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Up to 3 years | This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment |
| Secondary | Progression-free Survival (PFS) | 30 months | From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive without report of progression are censored at date of last contact. |
| Other | Number of Participants With c-MET Amplification, Deletion and No Alteration | Baseline | |
| Other | Number of Participants With EGFR Amplification, Deletion and No Alteration | Baseline |
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 | Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid Tumors | Up to 3 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 | Up to 3 years | All eligible patients who reported adverse events | Participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | 30 months | months | MEDIAN | |
| OTHER_PRE_SPECIFIED | Number of Participants With c-MET Amplification, Deletion and No Alteration | Baseline | Tissue was only obtained from 35 patients. Exome of 16 patients were successfully sequenced using Agilent SureSelect probes.~Arms were pooled due to no difference in response rate between the two arms | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With EGFR Amplification, Deletion and No Alteration | Baseline | Tissue was only obtained from 35 patients. Exome of 16 patients were successfully sequenced using Agilent SureSelect probes. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid Tumors | Arm I (Tivantinib) | Complete Response | 0 | Participants | |
| Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid Tumors | Arm II (Tivantinib and Erlotinib Hydrochloride) | Complete Response | 0 | Participants | |
| Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid Tumors | Arm I (Tivantinib) | Partial Response | 0 | Participants | |
| Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid Tumors | Arm II (Tivantinib and Erlotinib Hydrochloride) | Partial Response | 0 | Participants | |
| Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid Tumors | Arm I (Tivantinib) | Stable/no response | 11 | Participants | |
| Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid Tumors | Arm II (Tivantinib and Erlotinib Hydrochloride) | Stable/no response | 13 | Participants | |
| Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid Tumors | Arm I (Tivantinib) | Increasing disease | 14 | Participants | |
| Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid Tumors | Arm II (Tivantinib and Erlotinib Hydrochloride) | Increasing disease | 7 | Participants | |
| Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid Tumors | Arm I (Tivantinib) | Symptomatic deterioration | 0 | Participants | |
| Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid Tumors | Arm II (Tivantinib and Erlotinib Hydrochloride) | Symptomatic deterioration | 1 | Participants |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Tivantinib) | 27 | |
| Overall Study | STARTED | Arm II (Tivantinib and Erlotinib Hydrochloride) | 28 | |
| Overall Study | Eligible/Evaluable Patients | Arm I (Tivantinib) | 25 | |
| Overall Study | Eligible/Evaluable Patients | Arm II (Tivantinib and Erlotinib Hydrochloride) | 25 | |
| Overall Study | COMPLETED | Arm I (Tivantinib) | 25 | |
| Overall Study | COMPLETED | Arm II (Tivantinib and Erlotinib Hydrochloride) | 25 | |
| Overall Study | NOT COMPLETED | Arm I (Tivantinib) | 2 | |
| Overall Study | NOT COMPLETED | Arm II (Tivantinib and Erlotinib Hydrochloride) | 3 |
Source ClinicalTrials.gov
Adverse events210
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 | Anemia | Blood and lymphatic system disorders | Arm I (Tivantinib) | 10 | 25 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Tivantinib and Erlotinib Hydrochloride) | 7 | 25 | |
| other | Sinus bradycardia | Cardiac disorders | Arm I (Tivantinib) | 2 | 25 | |
| other | Sinus bradycardia | Cardiac disorders | Arm II (Tivantinib and Erlotinib Hydrochloride) | 4 | 25 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm I (Tivantinib) | 4 | 25 | |
| other | Abdominal pain | Gastrointestinal disorders | Arm II (Tivantinib and Erlotinib Hydrochloride) | 4 | 25 | |
| other | Bloating | Gastrointestinal disorders | Arm I (Tivantinib) | 3 | 25 | |
| other | Bloating | Gastrointestinal disorders | Arm II (Tivantinib and Erlotinib Hydrochloride) | 0 | 25 | |
| other | Constipation | Gastrointestinal disorders | Arm I (Tivantinib) | 5 | 25 | |
| other | Constipation | Gastrointestinal disorders | Arm II (Tivantinib and Erlotinib Hydrochloride) | 4 | 25 |
1 to 10 of 210Source ClinicalTrials.gov
See all 210 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Tivantinib) | 20 | 25 |
| Total, all-cause mortality | Arm II (Tivantinib and Erlotinib Hydrochloride) | 21 | 25 |
| Total, other adverse events | Arm I (Tivantinib) | 22 | 25 |
| Total, other adverse events | Arm II (Tivantinib and Erlotinib Hydrochloride) | 23 | 25 |
| Total, serious adverse events | Arm I (Tivantinib) | 9 | 25 |
| Total, serious adverse events | Arm II (Tivantinib and Erlotinib Hydrochloride) | 16 | 25 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|---|
| U10CA180888 | SWOG Network Group Operations Center of the NCTN | LARA, PRIMO N.; HERSHMAN, DAWN | UNIVERSITY OF CALIFORNIA AT DAVIS | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA032102 | Southwest Oncology Group Treatment Grant | BLANKE, CHARLES D. | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I (Tivantinib) vs Arm II (Tivantinib and Erlotinib Hydrochloride): deaths from any cause | Trial comparisons |
| Arm I (Tivantinib) vs Arm II (Tivantinib and Erlotinib Hydrochloride): 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/NCT01688973
GET https://conductscience.org/api/trials/v1/NCT01688973/results?page=2