Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
Conditions
Brief summary
This randomized phase II trial studies how well giving cabozantinib-s-malate or paclitaxel works in treating patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cavity cancer. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether cabozantinib-s-malate or paclitaxel is more effective at treating patients with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cavity cancer.
Detailed description
PRIMARY OBJECTIVES: I. To assess the activity of cabozantinib (cabozantinib-s-malate) relative to weekly paclitaxel in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer with a log-rank test assessing progression-free survival (PFS) at 3.68 months (approximately pre-cycle 5) and 7.36 months (approximately pre-cycle 9). SECONDARY OBJECTIVES: I. To determine the frequency and severity of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE). II. To estimate and compare the proportion of patients responding to therapy by Response Evaluation Criteria for Solid Tumors (RECIST), cancer antigen 125 (CA125) response, the overall survival (OS), and the duration of response in each arm. TERTIARY OBJECTIVES: I. To retrospectively correlate c-met proto-oncogene (MET) expression with overall outcome. II. To retrospectively correlate c-MET copy number with overall outcome. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive cabozantinib-s-malate orally (PO) once daily (QD) on days 1-28. ARM II: Patients receive paclitaxel intravenously (IV) over 1 hour on days 1, 8, and 15. 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 2 years and then every 6 months for 3 years.
Interventions
DRUGCabozantinib S-malate
Given PO
OTHERLaboratory Biomarker Analysis
Correlative studies
DRUGPaclitaxel
Given IV
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma; histologic documentation of the original primary tumor is required via the pathology report * Patients must have measurable disease or non-measurable (detectable) disease: * Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be greater than or equal to 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or greater than or equal to 20 mm when measured by chest x-ray; lymph nodes must be greater than or equal to 15 mm in short axis when measured by CT or MRI * Non-measurable (detectable) disease is defined in this protocol as the absence of measurable disease but at least one of the following conditions: * Ascites and/or pleural effusion attributed to tumor * Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions * Patients with measurable disease must have at least one target lesion to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as non-target lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy * Patients must not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG phase III or rare tumor protocol for the same patient population; in addition, patients must not be eligible for the currently active phase II cytotoxic protocol in platinum resistant disease * Patients must have a GOG performance status of 0, 1, or 2 * Recovery from effects of recent surgery, radiotherapy, or chemotherapy to baseline or CTCAE =\< grade 1 toxicity from all prior therapies except alopecia and other non-clinically significant adverse events (AE's): * Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection \[UTI\]) * Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to treatment * Any other prior therapy directed at the malignant tumor, including chemotherapy, biological/targeted (non-cytotoxic) agents and immunologic agents, must be discontinued at least three weeks prior to treatment * Chimeric or human or humanized monoclonal antibodies (including bevacizumab) or vascular endothelial growth factor (VEGF) receptor fusion proteins (including VEGF TRAP/aflibercept) must be discontinued for at least 12 weeks prior to treatment * Investigational agents must be discontinued for at least 28 days prior to treatment * Any prior radiation therapy must be discontinued at least four weeks prior to treatment * Prior therapy * Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, consolidation, biologic/targeted (non-cytotoxic) agents (e.g., bevacizumab) or extended therapy administered after surgical or non-surgical assessment; if patients were treated with paclitaxel for their primary disease, this could have been given weekly or every 3 weeks * Patients are allowed to receive, but are not required to receive, two additional cytotoxic regimens for management of recurrent or persistent disease, with no more than 1 non-platinum, non-taxane regimen; treatment with weekly paclitaxel for recurrent or persistent disease is NOT allowed * Patients are allowed to receive, but are not required to receive, biologic/targeted (non-cytotoxic) therapy as part of their primary treatment regimen * Patients must have NOT received any biologic/targeted (non-cytotoxic) therapy targeting the VEGF and/or MET pathways for management of recurrent or persistent disease * For the purposes of this study, poly (adenosine diphosphate \[ADP\]-ribose) polymerase (PARP) inhibitors will be considered cytotoxic; patients are allowed to receive, but are not required to receive, PARP inhibitors for management of primary or recurrent/persistent disease (either alone or in combination with cytotoxic chemotherapy); PARP inhibitors will NOT count as a prior regimen when given alone * Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl * Platelets greater than or equal to 100,000/mcl * Hemoglobin greater than or equal to 9 g/dL * Prothrombin time (PT) such that international normalized ratio (INR) is less than or equal to 1.3 x institutional upper limit of normal (ULN) * Partial thromboplastin time (PTT) less than or equal to 1.3 x ULN * Creatinine less than or equal to 1.5 x ULN * Phosphorus, corrected calcium, magnesium and potassium greater than or equal to institutional lower limit of normal (LLN) * Urine protein creatinine (UPC) ratio must be \< 1.0 gm; if UPC ratio \>= 1, collection of 24-hour urine measurement of urine protein is recommended * Bilirubin less than or equal to 1.5 x ULN * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 x ULN * Alkaline phosphatase less than or equal to 2.5 x ULN * Albumin greater than or equal to 2.8 g/dL * Lipase less than or equal to 2 x ULN * No radiologic or clinical evidence of pancreatitis * Patients must have a normal baseline thyroid stimulating hormone (TSH); a history of hypothyroidism and/or hyperthyroidism is allowed * Neuropathy (sensory and motor) less than or equal to grade 1 * Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception; sexually active subjects must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the course of the study and for 4 months after the last dose of study drug, even if oral contraceptives are also used; all subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 4 months after the last dose of study drug; pregnant women are excluded from this study * Patients must have signed an approved informed consent and authorization permitting the release of personal health information * Patients must meet pre-entry requirements
Exclusion criteria
* Patients who have had previous treatment with cabozantinib; patients who have received previous treatment with weekly paclitaxel for recurrent or persistent disease * Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies, are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy * Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis or thoracic cavity within the last three years are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease * Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease * Uncontrolled hypertension, defined as systolic greater than 140 mm Hg or diastolic greater than 90 mm Hg despite antihypertensive medications * Myocardial infarction or unstable angina within 6 months prior to registration * New York Heart Association (NYHA) class II or greater congestive heart failure * History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) or serious cardiac arrhythmia requiring medication; this does not include asymptomatic atrial fibrillation with controlled ventricular rate * Any history of congenital long QT syndrome * The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) \> 500 ms within 28 days before randomization; note: if initial QTcF is found to be \> 500 ms, two additional electrocardiogram (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =\< 500 ms, the subject meets eligibility in this regard * Patients with serious non-healing wound, ulcer, or bone fracture within 28 days before treatment * Patients with history of organ transplant * Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving (in contact with, invading or encasing) major vessels * Patients who have experienced any of the following: * Clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment * Hemoptysis of \>= 0.5 teaspoon (2.5 mL) of red blood within 3 months before the first dose of study treatment * Any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment * Patients who have radiographic evidence of cavitating pulmonary lesion(s) * Patients who have tumor invading the gastrointestinal (GI) tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before treatment * Gastrointestinal disorders, particularly those with potential risk of perforation or fistula formation including: * Any of the following within 28 days of registration * Intra-abdominal tumor/metastases invading GI mucosa * Active peptic ulcer disease * Inflammatory bowel disease (including ulcerative colitis and Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis * Malabsorption syndrome * Any of the following within 6 months of registration * Abdominal fistula * Gastrointestinal perforation * Bowel obstruction or gastric outlet obstruction; note: patients requiring drainage gastrostomy (e.g., percutaneous endoscopic gastrostomy \[PEG\] tube) and/or parenteral hydration and/or nutrition are not eligible * Intra-abdominal abscess; note: complete resolution of an intra-abdominal abscess must be confirmed prior to registration even if the abscess occurred more than 6 months prior to registration * Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures which are not controlled with non-enzyme inducing anticonvulsants, any brain metastases and/or epidural disease, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months prior to the first date of study treatment * The subject requires chronic concomitant treatment of strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John's wort) * Patients who are unable or unwilling to swallow tablets * Patients who are pregnant or nursing * The subject requires concomitant treatment, in therapeutic doses, with anti-coagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors or antiplatelet agents (i.e. clopidogrel); low dose aspirin (=\< 81 mg/day) low-dose warfarin (=\< 1 mg/day) and prophylactic low molecular weight heparin are permitted * Major surgery within 3 months of the first dose of cabozantinib if there were no wound healing complications or within 6 months of the first dose of cabozantinib if there were wound complications * Minor surgery within 1 month of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications * Patients with concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event Free Survival | The duration of time from study entry to time to progression or death,or begining a subsequent therapy, whichever occurs first, assessed up to 32 weeks | Time from patient entry until progression, death, or beginning a subsequent therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR., |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Grade 3 or Higher Adverse Events by Type | Up to 30 days after completion of study treatment | Toxicities will be characterized by their frequency and severity, grade 3 and above. |
| Response, Assessed According to RECIST Version 1.1 | CT or MRI used to follow lesion every 8 weeks for the first 8 months, then every 12 weeks until disease progression, approximately 2.5 years | Complete and Partial Tumor Response by RECIST. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
| Percentage of Participants With CA125 Response. | Prior to each cycle of treatment. Then follow-up every 3 months for 2 years then then every 6 months, up to 2.5 years. | Complete and Partial Tumor Response by CA125. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR., |
| Overall Survival | The duration of time from study entry to time of death or the date of last contact, an average of 2.5 years. | The time from randomization until death or date of last contact. Endpoint is death. Patients who are not observed with an endpoint are censored. |
| To Estimate the Response Duration Among Patients Who Respond. | From the time measurement criteria are met for CR or PR until the first date that recurrent or progressive disease is objectively documented or date of death from any cause, whichever came first, assessed up to 18 months. | The time participant is in response.Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR., |
Other
| Measure | Time frame |
|---|---|
| c-Met Expression | Baseline |
| c-MET Copy Number | Baseline |
Countries
United States
Participant flow
Recruitment details
111 patients were enrolled from November 6, 2012 to May 5, 2014
Participants by arm
| Arm | Count |
|---|---|
| Cabozantinib Cabozantinib 60 mg oral daily continously | 57 |
| Paclitaxel Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15 | 54 |
| Total | 111 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Never Treated | 2 | 4 |
Baseline characteristics
| Characteristic | Cabozantinib | Paclitaxel | Total |
|---|---|---|---|
| Age, Customized 20-29 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 30-39 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Customized 40-49 years | 5 Participants | 4 Participants | 9 Participants |
| Age, Customized 50-59 years | 21 Participants | 19 Participants | 40 Participants |
| Age, Customized 60-69 years | 20 Participants | 24 Participants | 44 Participants |
| Age, Customized 70-79 years | 9 Participants | 6 Participants | 15 Participants |
| Age, Customized >=80 years | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 50 Participants | 48 Participants | 98 Participants |
| Sex: Female, Male Female | 57 Participants | 54 Participants | 111 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 55 / 55 | 50 / 50 |
| serious Total, serious adverse events | 25 / 55 | 8 / 50 |
Outcome results
Primary
Event Free Survival
Time from patient entry until progression, death, or beginning a subsequent therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.,
Time frame: The duration of time from study entry to time to progression or death,or begining a subsequent therapy, whichever occurs first, assessed up to 32 weeks
Population: Enrolled Patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cabozantinib | Event Free Survival | 3.48 months |
| Paclitaxel | Event Free Survival | 4.96 months |
Secondary
Number of Participants With Grade 3 or Higher Adverse Events by Type
Toxicities will be characterized by their frequency and severity, grade 3 and above.
Time frame: Up to 30 days after completion of study treatment
Population: Eligible and Treated participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cabozantinib | Number of Participants With Grade 3 or Higher Adverse Events by Type | Neutropenia | 2 Participants |
| Cabozantinib | Number of Participants With Grade 3 or Higher Adverse Events by Type | Anemia | 4 Participants |
| Cabozantinib | Number of Participants With Grade 3 or Higher Adverse Events by Type | Gastrointestinal | 15 Participants |
| Cabozantinib | Number of Participants With Grade 3 or Higher Adverse Events by Type | Metabolism/nutrition | 10 Participants |
| Cabozantinib | Number of Participants With Grade 3 or Higher Adverse Events by Type | Musculoskeletal/connective tissue | 1 Participants |
| Cabozantinib | Number of Participants With Grade 3 or Higher Adverse Events by Type | Nervous System | 3 Participants |
| Cabozantinib | Number of Participants With Grade 3 or Higher Adverse Events by Type | Renal/Urinary | 1 Participants |
| Cabozantinib | Number of Participants With Grade 3 or Higher Adverse Events by Type | Respiratory/thoracic/mediastinal | 3 Participants |
| Cabozantinib | Number of Participants With Grade 3 or Higher Adverse Events by Type | Skin/subcutaneous | 2 Participants |
| Cabozantinib | Number of Participants With Grade 3 or Higher Adverse Events by Type | Vascular disorders | 12 Participants |
| Paclitaxel | Number of Participants With Grade 3 or Higher Adverse Events by Type | Vascular disorders | 5 Participants |
| Paclitaxel | Number of Participants With Grade 3 or Higher Adverse Events by Type | Neutropenia | 4 Participants |
| Paclitaxel | Number of Participants With Grade 3 or Higher Adverse Events by Type | Nervous System | 0 Participants |
| Paclitaxel | Number of Participants With Grade 3 or Higher Adverse Events by Type | Anemia | 0 Participants |
| Paclitaxel | Number of Participants With Grade 3 or Higher Adverse Events by Type | Skin/subcutaneous | 0 Participants |
| Paclitaxel | Number of Participants With Grade 3 or Higher Adverse Events by Type | Gastrointestinal | 2 Participants |
| Paclitaxel | Number of Participants With Grade 3 or Higher Adverse Events by Type | Renal/Urinary | 0 Participants |
| Paclitaxel | Number of Participants With Grade 3 or Higher Adverse Events by Type | Metabolism/nutrition | 3 Participants |
| Paclitaxel | Number of Participants With Grade 3 or Higher Adverse Events by Type | Respiratory/thoracic/mediastinal | 1 Participants |
| Paclitaxel | Number of Participants With Grade 3 or Higher Adverse Events by Type | Musculoskeletal/connective tissue | 0 Participants |
Secondary
Overall Survival
The time from randomization until death or date of last contact. Endpoint is death. Patients who are not observed with an endpoint are censored.
Time frame: The duration of time from study entry to time of death or the date of last contact, an average of 2.5 years.
Population: All enrolled participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cabozantinib | Overall Survival | 19.4 months |
| Paclitaxel | Overall Survival | NA months |
Secondary
Percentage of Participants With CA125 Response.
Complete and Partial Tumor Response by CA125. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.,
Time frame: Prior to each cycle of treatment. Then follow-up every 3 months for 2 years then then every 6 months, up to 2.5 years.
Population: Participants evaluable by CA125
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cabozantinib | Percentage of Participants With CA125 Response. | 29.4 percentage of participants |
| Paclitaxel | Percentage of Participants With CA125 Response. | 58.6 percentage of participants |
Secondary
Response, Assessed According to RECIST Version 1.1
Complete and Partial Tumor Response by RECIST. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time frame: CT or MRI used to follow lesion every 8 weeks for the first 8 months, then every 12 weeks until disease progression, approximately 2.5 years
Population: All enrolled participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cabozantinib | Response, Assessed According to RECIST Version 1.1 | 7.02 percentage of participants |
| Paclitaxel | Response, Assessed According to RECIST Version 1.1 | 24.07 percentage of participants |
Secondary
To Estimate the Response Duration Among Patients Who Respond.
The time participant is in response.Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.,
Time frame: From the time measurement criteria are met for CR or PR until the first date that recurrent or progressive disease is objectively documented or date of death from any cause, whichever came first, assessed up to 18 months.
Population: Patients who respond.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cabozantinib | To Estimate the Response Duration Among Patients Who Respond. | 3.8 months |
| Paclitaxel | To Estimate the Response Duration Among Patients Who Respond. | 7.4 months |
Other Pre-specified
c-MET Copy Number
Time frame: Baseline
Other Pre-specified
c-Met Expression
Time frame: Baseline