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Study 07-PIR-02 is a Phase 2 study designed to evaluate the safety and efficacy of NKTR-102 (PEG-irinotecan) for the treatment of patients with colorectal cancer (CRC). The study is comprised of two sequential components - Phase 2a and Phase 2b. The Phase 2a portion is an open-label, dose-finding trial in multiple solid tumor types that are refractory to standard curative or palliative therapies. The primary endpoint of the Phase 2a is to establish the /recommended Phase 2 Dose (RPTD) of NKTR-102 by measuring the frequency of Dose Limiting Toxicity (DLT). The Phase 2b portion is an open-label, randomized, two-arm study in patients with second-line metastatic colorectal cancer and study participants will be randomized (1:1) to receive either NKTR-102 and cetuximab or irinotecan and cetuximab. The primary endpoint of the Phase 2b portion of the trial is progression-free survival. Secondary endpoints for both the Phase 2a and 2b portion include response rate, response duration, overall survival, standard pharmacokinetics, and incidence of toxicities, including diarrhea and neutropenia.
The Phase 2a portion of this study is completed. The following entries reflect the Phase 2a portion of this study only. The Phase 2b portion of the study was not enrolled. Based on emerging data regarding the corresponding low efficacy of cetuximab in patients with KRAS mutations, as well as revised NKTR-102 clinical development plans, the Phase 2b portion of the study was not completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NKTR-102 100 mg/m2 + Cetuximab | Active Comparator | NKTR-102 100 mg/m2 + Cetuximab Arm All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled. |
|
| NKTR-102 125 mg/m2 + Cetuximab | Active Comparator | NKTR-102 125 mg/m2 + Cetuximab Arm All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NKTR-102 100 mg/m2 | Drug | NKTR-102 100 mg/m2 + Cetuximab Arm: All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Dose Limiting Toxicities | Number of patients with Dose Limiting Toxicities | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Dose Limiting Toxicities by NCI-CTCAE | Number of patients with Dose Limiting Toxicities by NCI-CTCAE | 12 months |
| Number of Patients With Overall Response | Complete Response is defined as the disappearance of all target lesions. Partial Response is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. The best overall response was the best response recorded from the start of the study drug until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Nektar Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site - Scottsdale | Scottsdale | Arizona | 85258 | United States | ||
| Investigator Site - Louisville |
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| ID | Title | Description |
|---|---|---|
| FG000 | NKTR-102 100 mg/m2 + Cetuximab | NKTR-102 100 mg/m2 + Cetuximab Arm All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| NKTR-102 125 mg/m2 | Drug | NKTR-102 125 mg/m2 + Cetuximab Arm: All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled. |
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| Cetuximab | Drug | Cetuximab was administered once weekly via a 2-hour IV infusion at a starting dose of 400 mg/m2 on Day 1 and subsequently administered weekly at 250 mg/m2 via a 1-hour infusion thereafter. |
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| 12 months |
| Louisville |
| Kentucky |
| 40202 |
| United States |
| Investigator Site - Dallas | Dallas | Texas | 75426 | United States |
| Investigator Site - Tyler | Tyler | Texas | 75702 | United States |
| FG001 | NKTR-102 125 mg/m2 + Cetuximab | NKTR-102 125 mg/m2 + Cetuximab Arm All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled. |
| Completed Cycle 1 |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | NKTR-102 100 mg/m2 + Cetuximab | All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled. |
| BG001 | NKTR-102 125 mg/m2 + Cetuximab | All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Copies of UGT1A1*28 | Count of Participants | Participants |
| ||||||||||||||||
| ECOG Performance | GRADE - ECOG PERFORMANCE STATUS 0 - Fully active, able to carry on all pre-disease performance without restriction
| Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Dose Limiting Toxicities | Number of patients with Dose Limiting Toxicities | ITT/Safety Population | Posted | Count of Participants | Participants | 12 months |
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| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Dose Limiting Toxicities by NCI-CTCAE | Number of patients with Dose Limiting Toxicities by NCI-CTCAE | ITT/Safety Population | Posted | Count of Participants | Participants | 12 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Overall Response | Complete Response is defined as the disappearance of all target lesions. Partial Response is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. The best overall response was the best response recorded from the start of the study drug until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). | ITT/Safety Population | Posted | Count of Participants | Participants | 12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NKTR-102 100 mg/m2 + Cetuximab | NKTR-102 100 mg/m2 + Cetuximab Arm All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled. | 1 | 12 | 5 | 12 | 12 | 12 |
| EG001 | NKTR-102 125 mg/m2 + Cetuximab | NKTR-102 125 mg/m2 + Cetuximab Arm All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled. | 0 | 6 | 3 | 6 | 6 | 6 |
| EG002 | Total | NKTR-102 Overall Tota All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled.l | 1 | 18 | 8 | 18 | 18 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Renal acute failure | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Epigastric discomfort | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Oral pain | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Pancreatic insufficiency | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Chills | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Adverse drug reaction | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Facial pain | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Mucosal inflammation | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Skin candida | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
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| Wound complication | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
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| Activated partial thromboplastin time prolonged | Investigations | MedDRA (11.0) | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA (11.0) | Systematic Assessment |
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| Ejection fraction decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
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| Haematocrit decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
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| Red blood cell count decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
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| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Muscle atrophy | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Restless legs syndrome | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA (11.0) | Systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
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| Vaginal discharge | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Nail discomfort | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Sinus operation | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
None reported.
There are restrictions to the PI's rights to discuss or publish trial results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Nektar Therapeutics | medicalaffairs@nektar.com |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C581703 | etirinotecan pegol |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
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| Male |
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| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| One Copy (Heterozygous) |
|
| Two Copies (Homozygous) |
|
| 1 |
|
| 2 |
|
| Title | Measurements |
|---|---|
|
| Renal Failure Acute |
|
|
|
| OG002 | Total | NKTR-102 Overall Total All patients received NKTR-102 in combination with cetuximab. NKTR-102 was administered intravenously (IV) once every 3 weeks (q3w) over 90 minutes on Day 1. Patients were to be enrolled in one of the following sequential dosing cohorts of NKTR-102: 100, 125, 150, or 175 mg/m2. Only the 100 and 125 mg/m2 were enrolled. |
|
|