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The purpose of this study is to determine the maximum tolerated dose of RX-0201, up to a target dose of 250 mg/m^2/day, when given in combination with everolimus (Stage 1), and to assess the safety and efficacy of RX-0201 plus everolimus, in subjects with metastatic renal cell cancer (Stage 2).
This multi-center, open-label, randomized, parallel group study of RX-0201 in combination with everolimus, versus everolimus alone to treat subjects with advanced renal cell carcinoma will be conducted in 2 stages. Stage 1 will be an open-label, dose-escalation study of RX-0201 to identify a safe and tolerable dose of RX-0201 up to a target dose of 250 mg/m^2/day when given in combination with everolimus. Stage 2 will be a randomized, open-label, 2-arm study of RX-0201 in combination with everolimus versus everolimus alone. Subjects will receive RX-0201, at the dose identified in Stage 1, in combination with everolimus or everolimus alone, for up to 8 cycles to determine safety and efficacy of the combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RX-0201 plus everolimus (Stage 1 & 2) | Experimental | RX-0201 and everolimus will be taken together as described in the Interventions description. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RX-0201 | Drug | RX-0201 will be administered in a dose up to 250mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. In Stage 2, RX-0201 will be administered the dose determined in Stage 1 as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose-limiting Toxicities (DLTs) (Stage 1) | Incidence of adverse events and clinical laboratory abnormalities defined as dose-limiting toxicities | after 1 cycle (3 weeks) of treatment with RX-0201 and everolimus |
| Progression Free Survival (Stage 2) | Median PFS. Progression determined by RECIST v1.1 | 4 months of treatment with RX-0201 and everolimus |
| Measure | Description | Time Frame |
|---|---|---|
| Steady State Concentration (Css) of RX-0201 (Stage 1) | Css of RX-0201 at the beginning and end of the 14 day continuous infusion | predose, 1, 2, 3, 4, 6, and 24 hours after start of Cycle 1 RX-0201 infusion, and then immediately prior to the end of Cycle 1 infusion (Day 15), 1, 2, 3, 4, 6, and 24 hours after infusion is stopped |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker Concentrations in Blood | Exploratory analysis of AKT pathway biomarkers, tumor apoptosis biomarkers and other biomarkers in blood or tumor samples | Baseline and at weeks 6, 12, 18, and 24 |
| RX-0201 Concentration in the Blood (Stage 2 Only) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ely Benaim, MD | Rexahn Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rexahn Site | Tucson | Arizona | 85719 | United States | ||
| Rexahn Site |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | 125 mg/m^2/Day RX-0201 + Everolimus (Stage 1) | RX-0201 was administered as 125 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days |
| FG001 | 200 mg/m^2/Day RX-0201 + Everolimus (Stage 1) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 8, 2017 | Feb 24, 2020 |
Not provided
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|
|
| Incidence of Adverse Events, Changes in Clinical Laboratory Tests and Vital Signs Over Time (Stage 1 and Stage 2) |
safety of RX-0201 was evaluated through reporting using the grading system in the CTCAE version 4.03 for adverse events and laboratory abnormalities. All statistical methods for safety were descriptive in nature. |
| up to 24 weeks of treatment with RX-0201 plus everolimus and at least 30 days of safety follow up |
| Best Overall Response as Determined by RECIST v1.1. | Best overall response as determined by RECIST v1.1. Not Evaluable included the subjects who had completed at least one treatment cycle but no overall response evaluation. Not Done included the subjects who dropped out from the study without completing any treatment cycle and overall response evaluation. The best overall response for each subject from all post-baseline time point overall responses was used. The best overall response was the best response recorded from the start of the treatment until disease progression/recurrence, or occurrence of intolerable toxicity, whatever came first. | Baseline and at weeks 6, 12, 18, and 24 |
Exploratory analysis of plasma concentrations of RX-0201 at the end of infusion
| After 2 weeks of treatment |
| Duarte |
| California |
| 91010 |
| United States |
| Rexahn Site | Albuquerque | New Mexico | 87106 | United States |
| Rexahn Site | New York | New York | 10065 | United States |
| Rexahn Site | The Bronx | New York | 10467 | United States |
| Rexahn Site | Salt Lake City | Utah | 84112 | United States |
| Rexahn Site | Seattle | Washington | 98101 | United States |
RX-0201 was administered as 200 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days |
| FG002 | 250 mg/m^2/Day RX-0201 + Everolimus (Stage 1) | RX-0201 was administered as 250 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days |
| FG003 | 250 mg/m^2/Day RX-0201 + Everolimus (Stage 2) | RX-0201 was administered as 250 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 2 after determination of the maximum tolerated dose in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days |
| Received Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 125 mg/m^2/Day RX-0201 + Everolimus (Stage 1) | RX-0201 was administered as 125 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days |
| BG001 | 200 mg/m^2/Day RX-0201 + Everolimus (Stage 1) | RX-0201 was administered as 200 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days |
| BG002 | 250 mg/m^2/Day RX-0201 + Everolimus (Stage 1) | RX-0201 was administered as 250 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days |
| BG003 | 250 mg/m^2/Day RX-0201 + Everolimus (Stage 2) | RX-0201 was administered as 250 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 2 after the determination of MTD in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days |
| BG004 | 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 |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| ECOG | 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 | Incidence of Dose-limiting Toxicities (DLTs) (Stage 1) | Incidence of adverse events and clinical laboratory abnormalities defined as dose-limiting toxicities | DLTs were only applicable to Stage 1. | Posted | Count of Participants | Participants | after 1 cycle (3 weeks) of treatment with RX-0201 and everolimus |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Progression Free Survival (Stage 2) | Median PFS. Progression determined by RECIST v1.1 | Progression Free Survival (PFS) was determined only in the Stage 2 population. | Posted | Median | Standard Deviation | days | 4 months of treatment with RX-0201 and everolimus |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Steady State Concentration (Css) of RX-0201 (Stage 1) | Css of RX-0201 at the beginning and end of the 14 day continuous infusion | Stage 1 subjects who had sufficient PK samples for analysis | Posted | Geometric Mean | Standard Deviation | ng/ml | predose, 1, 2, 3, 4, 6, and 24 hours after start of Cycle 1 RX-0201 infusion, and then immediately prior to the end of Cycle 1 infusion (Day 15), 1, 2, 3, 4, 6, and 24 hours after infusion is stopped |
| |||||||||||||||||||||||||||||||||
| Secondary | Incidence of Adverse Events, Changes in Clinical Laboratory Tests and Vital Signs Over Time (Stage 1 and Stage 2) | safety of RX-0201 was evaluated through reporting using the grading system in the CTCAE version 4.03 for adverse events and laboratory abnormalities. All statistical methods for safety were descriptive in nature. | Not Posted | up to 24 weeks of treatment with RX-0201 plus everolimus and at least 30 days of safety follow up | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | Best Overall Response as Determined by RECIST v1.1. | Best overall response as determined by RECIST v1.1. Not Evaluable included the subjects who had completed at least one treatment cycle but no overall response evaluation. Not Done included the subjects who dropped out from the study without completing any treatment cycle and overall response evaluation. The best overall response for each subject from all post-baseline time point overall responses was used. The best overall response was the best response recorded from the start of the treatment until disease progression/recurrence, or occurrence of intolerable toxicity, whatever came first. | All enrolled subjects with subjects analyzed according to the treatment assigned at enrollment/ randomization. | Posted | Count of Participants | Participants | Baseline and at weeks 6, 12, 18, and 24 |
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Biomarker Concentrations in Blood | Exploratory analysis of AKT pathway biomarkers, tumor apoptosis biomarkers and other biomarkers in blood or tumor samples | Not Posted | Baseline and at weeks 6, 12, 18, and 24 | Participants | |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | RX-0201 Concentration in the Blood (Stage 2 Only) | Exploratory analysis of plasma concentrations of RX-0201 at the end of infusion | Not Posted | After 2 weeks of treatment | Participants |
Adverse events were collected from the time of first dose until the 30 days after the last dose of study drug.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 125 mg/m^2/Day RX-0201 + Everolimus (Stage 1) | RX-0201 was administered as 125 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days | 0 | 3 | 2 | 3 | 3 | 3 |
| EG001 | 200 mg/m^2/Day RX-0201 + Everolimus (Stage 1) | RX-0201 was administered as 200 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days | 0 | 4 | 1 | 4 | 4 | 4 |
| EG002 | 250 mg/m^2/Day RX-0201 + Everolimus (Stage 1) | RX-0201 was administered as 250 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days | 0 | 3 | 2 | 3 | 3 | 3 |
| EG003 | RX-0201 Plus Everolimus (Stage 2) | RX-0201 was administered as 250 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 2 after determination of MTD in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days | 0 | 11 | 4 | 11 | 11 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Gastroenteritis radiation | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Hypophosphotaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
|
Early termination lead to small numbers of subjects analyzed. Missing samples and technical problems with the bioanalysis resulted in uninterpretable PK data.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Doug Swirsky/ Chief Executive Officer | Rexahn Pharmaceuticals Inc. | 240-268-5300 | swirskyd@rexahn.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 7, 2018 | Feb 24, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D007680 | Kidney Neoplasms |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000632490 | RX-0201 |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| ECOG = 1 |
|
| ECOG = 2 |
|
|
|
|
| OG002 | 250 mg/m^2/Day RX-0201 + Everolimus (Stage 1) | RX-0201 was administered as 250 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days |
| OG003 | RX-0201 Plus Everolimus (Stage 2) | RX-0201 was administered as 250 mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 2 after determination of MTD in Stage 1. 10 mg everolimus was taken daily for a cycle of 21 days |
|
|