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Tivantinib With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Locally Advanced Kidney Cancer That Cannot Be Removed by Surgery

Parallel (Randomized) Phase II Evaluation of ARQ 197 and ARQ 197 in Combination With Erlotinib in Papillary Renal Cell Carcinoma

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01688973
Enrollment
55
Registered
2012-09-20
Start date
2012-08-20
Completion date
2017-04-30
Last updated
2019-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief summary

This randomized phase II trial studies how well tivantinib with or without erlotinib hydrochloride works in treating patients with metastatic or locally advanced kidney cancer that cannot be removed by surgery. Tivantinib and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To assess the response rate (confirmed complete and partial response) of patients with locally advanced or metastatic papillary renal cell carcinoma treated with either ARQ 197 (tivantinib) or ARQ 197 combined with erlotinib (erlotinib hydrochloride). SECONDARY OBJECTIVES: I. To assess the progression free survival (PFS) of patients with locally advanced or metastatic papillary renal cell carcinoma treated with either ARQ 197 or ARQ 197 combined with erlotinib. II. To assess the safety and tolerability of ARQ 197 therapy and ARQ 197 combined with erlotinib. III. To descriptively assess the role of prior treatment on outcome. TERTIARY OBJECTIVES: I. To bank tissue specimens for future use and once funding is obtained to evaluate the expression of tissue correlative biomarkers such as hepatocyte growth factor receptor (c-MET) and epidermal growth factor receptor (EGFR), and to perform exploratory correlation with clinical outcomes. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive tivantinib orally (PO) twice daily (BID) on days 1-28. ARM II: Patients receive tivantinib PO BID and erlotinib hydrochloride PO once daily (QD) on days 1-28. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for up to 2 years.

Interventions

DRUGErlotinib Hydrochloride

150 mg (1 tablet) by mouth on days 1-28, once daily, until disease progression

OTHERLaboratory Biomarker Analysis

Correlative studies

360 mg (3 tablets) by mouth, Twice daily (720 mg total daily dose) on days 1-28, until disease progression

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients must have histologically or cytologically confirmed papillary histology renal cell carcinoma which is metastatic, or locally advanced and unresectable; mixed histologies will be allowed provided that they contain \>= 50% of the papillary component * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension; x-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; x-rays, scans or physical examinations for non-measurable disease must have been completed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment form * Patients with metastatic disease who have a resectable primary tumor and are deemed a surgical candidate may have undergone resection; at least 28 days must have elapsed since surgery and patient must have recovered from any adverse effects of surgery * Patients with a history of brain metastases who are asymptomatic and have not received steroid therapy in the 14 days prior to registration are eligible; anti-seizure medications are allowed provided they are non-enzyme inducing (e.g. topiramate, levetiracetam, gabapentin) * Patients may have received up to one prior systemic therapy for advanced or metastatic renal cell carcinoma; patients must not have received a MET inhibitor or erlotinib as prior therapy; at least 21 days must have elapsed since completion of prior systemic therapy, 42 days for nitrosoureas or mitomycin C; patients must have recovered from all associated toxicities at the time of registration * Patients may have received prior radiation therapy, but must have measurable disease outside the radiation port; at least 21 days must have elapsed since completion of prior radiation therapy; patients must have recovered from all associated toxicities at the time of registration * Patients must not be receiving or planning to receive any other investigational agents * Patients must have a complete physical examination and medical history within 28 days prior to registration * Patients must have a Zubrod performance status of 0-2 * White blood cell (WBC) \>= 2,000/mcL * Absolute neutrophil count (ANC) \>= 1,000/mcL * Platelet count \>= 75,000/mcL * Serum bilirubin =\< 1.5 x institutional upper limits of normal (ULN) * Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) and serum glutamic pyruvate transaminase (SGPT)/alanine aminotransferase (ALT) must be =\< 1.5 x the institutional ULN unless the liver is involved with the tumor, in which case serum transaminase (SGOT/SGPT) must be =\< 5 x the institutional ULN * Serum creatinine must be =\< 2 x the institutional ULN * Sodium, potassium and calcium must be obtained within 14 days prior to registration * Patients with a known history of the following corneal diseases are not eligible: dry eye syndrome, Sjogren's syndrome, keratoconjunctivitis sicca, exposure keratopathy, Fuchs' dystrophy or other active disorders of cornea * Patients known to be human immunodeficiency virus (HIV)-positive and receiving combination anti-retroviral therapy are not eligible * Patients must be able to take oral medications; patients must not have gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease; patients with intractable nausea or vomiting are not eligible * Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of reproductive potential if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, effective contraception also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures * No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years * Patients must be offered the opportunity to participate in specimen banking for future translational medicine studies * All patients must be informed of the investigational nature of this study and must sign and give written informed consent * As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Design outcomes

Primary

MeasureTime frameDescription
Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid TumorsUp to 3 yearsBest 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

MeasureTime frameDescription
Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Up to 3 yearsThis 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
Progression-free Survival (PFS)30 monthsFrom 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

MeasureTime frame
Number of Participants With c-MET Amplification, Deletion and No AlterationBaseline
Number of Participants With EGFR Amplification, Deletion and No AlterationBaseline

Countries

United States

Participant flow

Participants by arm

ArmCount
Arm I (Tivantinib)
Patients receive tivantinib PO BID on days 1-28. Laboratory Biomarker Analysis: Correlative studies Tivantinib: Given PO
25
Arm II (Tivantinib and Erlotinib Hydrochloride)
Patients receive tivantinib PO BID and erlotinib hydrochloride PO QD on days 1-28. Erlotinib Hydrochloride: Given PO Laboratory Biomarker Analysis: Correlative studies Tivantinib: Given PO
25
Total50

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyIneligible23

Baseline characteristics

CharacteristicArm I (Tivantinib)Arm II (Tivantinib and Erlotinib Hydrochloride)Total
Age, Continuous62.1 years63.6 years63.6 years
Histologic Grade
1
0 Participants0 Participants0 Participants
Histologic Grade
2
3 Participants5 Participants8 Participants
Histologic Grade
3
7 Participants6 Participants13 Participants
Histologic Grade
4
4 Participants3 Participants7 Participants
Histologic Grade
Unknown
11 Participants11 Participants22 Participants
Histologic Subset
Mixed Histology
5 Participants2 Participants7 Participants
Histologic Subset
Pure Papillary
20 Participants23 Participants43 Participants
Histologic Type
Not Assigned
12 Participants14 Participants26 Participants
Histologic Type
Type I
2 Participants1 Participants3 Participants
Histologic Type
Type II
11 Participants10 Participants21 Participants
Performance Status
0
12 Participants9 Participants21 Participants
Performance Status
1
11 Participants13 Participants24 Participants
Performance Status
2
2 Participants3 Participants5 Participants
Performance Status
3
0 Participants0 Participants0 Participants
Performance Status
4
0 Participants0 Participants0 Participants
Prior Nephrectomy
No
4 Participants7 Participants11 Participants
Prior Nephrectomy
Yes
21 Participants18 Participants39 Participants
Prior Systemic Therapy
None
16 Participants17 Participants33 Participants
Prior Systemic Therapy
One
9 Participants8 Participants17 Participants
Race/Ethnicity, Customized
Race
Black
6 Participants5 Participants11 Participants
Race/Ethnicity, Customized
Race
Unknown
0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Race
White
19 Participants19 Participants38 Participants
Sex: Female, Male
Female
6 Participants10 Participants16 Participants
Sex: Female, Male
Male
19 Participants15 Participants34 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
20 / 2521 / 25
other
Total, other adverse events
22 / 2523 / 25
serious
Total, serious adverse events
9 / 2516 / 25

Outcome results

Primary

Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid Tumors

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.

Time frame: Up to 3 years

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Arm I (Tivantinib)Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid TumorsComplete Response0 Participants
Arm I (Tivantinib)Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid TumorsPartial Response0 Participants
Arm I (Tivantinib)Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid TumorsStable/no response11 Participants
Arm I (Tivantinib)Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid TumorsIncreasing disease14 Participants
Arm I (Tivantinib)Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid TumorsSymptomatic deterioration0 Participants
Arm I (Tivantinib)Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid TumorsNot Assessable0 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid TumorsSymptomatic deterioration1 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid TumorsComplete Response0 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid TumorsIncreasing disease7 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid TumorsPartial Response0 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid TumorsNot Assessable4 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid TumorsStable/no response13 Participants
Secondary

Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

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

Time frame: Up to 3 years

Population: All eligible patients who reported adverse events

ArmMeasureGroupValue (NUMBER)
Arm I (Tivantinib)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Lymphocyte count decreased1 Participants
Arm I (Tivantinib)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Febrile neutropenia0 Participants
Arm I (Tivantinib)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Myocardial infarction0 Participants
Arm I (Tivantinib)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Aspartate aminotransferase increased0 Participants
Arm I (Tivantinib)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Nausea1 Participants
Arm I (Tivantinib)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Hypertension1 Participants
Arm I (Tivantinib)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Neutrophil count decreased1 Participants
Arm I (Tivantinib)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Erythema multiforme0 Participants
Arm I (Tivantinib)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Pain in extremity1 Participants
Arm I (Tivantinib)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Hypoxia0 Participants
Arm I (Tivantinib)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Pneumonitis0 Participants
Arm I (Tivantinib)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Anemia2 Participants
Arm I (Tivantinib)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Rash acneiform0 Participants
Arm I (Tivantinib)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Infections and infestations - Other, specify0 Participants
Arm I (Tivantinib)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Rash maculo-papular0 Participants
Arm I (Tivantinib)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Fatigue0 Participants
Arm I (Tivantinib)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Stroke1 Participants
Arm I (Tivantinib)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Lung infection0 Participants
Arm I (Tivantinib)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Weight loss1 Participants
Arm I (Tivantinib)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Dyspnea1 Participants
Arm I (Tivantinib)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0White blood cell decreased1 Participants
Arm I (Tivantinib)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Alanine aminotransferase increased0 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0White blood cell decreased1 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Alanine aminotransferase increased1 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Anemia1 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Aspartate aminotransferase increased1 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Dyspnea1 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Erythema multiforme1 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Fatigue1 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Febrile neutropenia1 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Hypertension0 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Hypoxia1 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Infections and infestations - Other, specify1 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Lung infection1 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Lymphocyte count decreased0 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Myocardial infarction1 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Nausea0 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Neutrophil count decreased0 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Pain in extremity0 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Pneumonitis1 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Rash acneiform2 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Rash maculo-papular1 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Stroke0 Participants
Arm II (Tivantinib and Erlotinib Hydrochloride)Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0Weight loss0 Participants
Secondary

Progression-free Survival (PFS)

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.

Time frame: 30 months

ArmMeasureValue (MEDIAN)
Arm I (Tivantinib)Progression-free Survival (PFS)2.0 months
Arm II (Tivantinib and Erlotinib Hydrochloride)Progression-free Survival (PFS)3.9 months
Other Pre-specified

Number of Participants With c-MET Amplification, Deletion and No Alteration

Time frame: Baseline

Population: 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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Arm I (Tivantinib)Number of Participants With c-MET Amplification, Deletion and No AlterationAmplification6 Participants
Arm I (Tivantinib)Number of Participants With c-MET Amplification, Deletion and No AlterationDeletion0 Participants
Arm I (Tivantinib)Number of Participants With c-MET Amplification, Deletion and No AlterationNo Alteration10 Participants
Other Pre-specified

Number of Participants With EGFR Amplification, Deletion and No Alteration

Time frame: Baseline

Population: Tissue was only obtained from 35 patients. Exome of 16 patients were successfully sequenced using Agilent SureSelect probes.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Arm I (Tivantinib)Number of Participants With EGFR Amplification, Deletion and No AlterationAmplification3 Participants
Arm I (Tivantinib)Number of Participants With EGFR Amplification, Deletion and No AlterationDeletion1 Participants
Arm I (Tivantinib)Number of Participants With EGFR Amplification, Deletion and No AlterationNo Alteration12 Participants

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026