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Slow enrolment - standard of care evolved over the duration of the study such that treatment regimen employed in the study was no longer current standard of care for first line resulting in recruitment challenges.
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| Name | Class |
|---|---|
| Theradex | INDUSTRY |
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The primary purpose of this research study is to evaluate how safe, how well tolerated and how effective a range of doses of L-DOS47 in combination with standard doublet therapy of pemetrexed/carboplatin in patients with Stage IV (TNM M1a and M1b) recurrent or metastatic non-squamous Non-Small Cell Lung Cancer.
It is planned that patients will receive 4 cycles of combination treatment with L-DOS47 + pemetrexed/carboplatin. Patients who have not progressed following the 4 cycles of combination treatment and who have not experienced unacceptable toxicity will have the opportunity to continue to receive L-DOS47 treatment for as long as there is clinical benefit and it is well-tolerated, in the opinion of the Investigator, until disease progression. Patients who are unable to complete 4 cycles of L-DOS47 + pemetrexed/carboplatin combination treatment due to pemetrexed/carboplatin toxicity will have the opportunity to continue receiving L-DOS47 treatment following discontinuation of pemetrexed/carboplatin, for as long as there is clinical benefit and it is well-tolerated, in the opinion of the Investigator, until disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pemetrexed and Carboplatin plus L-DOS47 | Experimental | Patients will be recruited into cohorts of L-DOS47 escalating doses, with a minimum of 3 and a maximum of 6 patients per cohort for the first and last two dosing cohorts, and a minimum of 1 and a maximum of 2 patients for the middle three dosing cohorts. The starting dose of L-DOS47 will be 0.59 µg/kg; further planned dose levels to be assessed are 0.78, 1.5, 3.0, 6.0, 9.0 and 12.0 µg/kg. The standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], respectively, to be administered in combination with L-DOS47, will remain constant across cohorts. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-DOS47 | Drug | A treatment cycle will be 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Treatment Emergent Adverse Events as a Measure Safety and Tolerability of L-DOS47 in Combination Treatment With Pemetrexed/Carboplatin | Beginning with the start of study treatment at Cycle 1 Day 1 up to the last study visit: An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose which results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect. Beginning with the AE reporting period at the start of study treatment at Cycle 1 Day 1 up to the last study visit; | Up to 12 weeks |
| Number of Participants With Dose Limited Toxicities (DLTs) Related to L-DOS47 in Combination Treatment With Pemetrexed/Carboplatin. | A DLT was defined as the occurrence of any of the following events (according to NCI CTCAE version 4.0) that are considered to be (possibly/probably/definitely) related to L-DOS47 and occurring within 21 days after commencing study treatment:
| Up to 21 days |
| Maximum Tolerated Dose of L-DOS47 in Combination With Pemetrexed/Carboplatin | Defined as the highest dose level at which ≤ 1 of 6 patients experiences a dose limiting toxicity (DLT) as assessed during the first treatment cycle. If no DLT are reported, it is assumed that the maximum tolerated dose of L-DOS47 in combination with pemetrexed/carboplatin was not reached. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate of Patients Receiving the Combination Treatment According to RECIST 1.1 | Objective tumor response will be assessed according to RECIST version 1.1 in patients who have completed at least 2 cycles of study treatment and who have at least 1 post-treatment disease assessment; where complete response (CR) is the disappearance of all target lesions and partial response (PR) is at least a 30% reduction in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Case Medical Center | Cleveland | Ohio | United States | |||
| The University of Texas MD Anderson Cancer Center |
Not provided
| Label | URL |
|---|---|
| Helix BioPharma corporate website | View source |
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A total of 14 study subjects diagnosed with metastatic or recurrent non-small cell lung cancer (NSCLC) were enrolled to receive planned escalating doses of L-DOS47 (0.59 - 12.0 ug/kg) in combination with standard doses of carboplatin and pemetrexed.
Study subjects were enrolled at three study sites in the United States from April 2014 to August 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 0.59 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. |
| FG001 | L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 0.78 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. |
| FG002 | L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 1.5 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. |
| FG003 | L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 3.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. |
| FG004 | L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 6.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. |
| FG005 | L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 9.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. |
| FG006 | L-DOS47 12.0 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 12.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
There were no patients enrolled in cohort 7 (L-DOS47 12.0 ug/kg), as the study was concluded due to slow recruitment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 0.59 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 Treatment Emergent Adverse Events as a Measure Safety and Tolerability of L-DOS47 in Combination Treatment With Pemetrexed/Carboplatin | Beginning with the start of study treatment at Cycle 1 Day 1 up to the last study visit: An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose which results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect. Beginning with the AE reporting period at the start of study treatment at Cycle 1 Day 1 up to the last study visit; | Any subject who has received any amount of study treatment. | Posted | Count of Participants | Participants | Up to 12 weeks |
|
Adverse event (AE) reporting period commenced after initial dosing of pemetrexed premedication through 30-day post-last dose of study drug, up to 15 weeks, or longer for those patients who continue on additional treatment cycles. If an AE occurred before first dose of study drug, it would be considered a non-treatment emergent AE. All AEs were followed until resolution/stabilization while patient remained on-study.
Once a patient was removed from study, events thought to be related to the study drug were followed until resolution/stabilization, unless, in the opinion of the investigator, event is unlikely to resolve due to the patient's underlying disease, or until the patient starts a new treatment regiment or is lost to follow-up.
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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 | L-DOS47 0.59 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 0.59 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
Patient enrolment was halted at cohort 6 (9.0 ug/kg) due to slow recruitment and therefore, the seventh and highest dosing cohort (12 ug/kg) could not be completed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brenda Lee, Director, Clinical Operations | Helix BioPharma Corp. | 416 642 1807 | blee@helixbiopharma.com |
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 | Aug 10, 2017 | Jun 27, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 17, 2019 | Jun 27, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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Single arm, dose escalation where patients are recruited into cohorts of escalating doses of L-DOS47 (0.59 up to 12.0 µg/kg) in combination with pemetrexed and carboplatin.
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| Up to 12 weeks |
| Percentage of Patients Receiving a Sustained Clinical Benefit | Defined as the percentage of patients who have achieved complete response, partial response, or stable disease following combination treatment with L-DOS47 + pemetrexed/carboplatin; where complete response (CR) is the disappearance of all target lesions, partial response (PR) is at least a 30% reduction in the sum of diameters of target lesions, taking as reference the baseline sum diameters, and stable disease (SD) is where neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD, at least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study). | Up to 12 weeks |
| Houston |
| Texas |
| United States |
| Adverse Event |
|
| Progressive Disease |
|
| Death |
|
| BG001 | L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 0.78 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. |
| BG002 | L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 1.5 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. |
| BG003 | L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 3.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. |
| BG004 | L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 0.78 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. |
| BG005 | L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 9.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. |
| BG006 | L-DOS47 12.0 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 12.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. |
| BG007 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ECOG Performance Status | ECOG performance status describes how daily living activities of the patient are affected by disease. ECOG of 0 means the patient is fully active without restriction. ECOG of 1 means the patient is restricted in physically strenuous activity but is able to carry out light work. The investigator assigned the ECOG score at baseline (i.e., before the patient started study treatment). | Count of Participants | Participants |
|
Subjects were to receive a weekly dose 0.59 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. |
| OG001 | L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 0.78 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. |
| OG002 | L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 1.5 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. |
| OG003 | L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 3.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. |
| OG004 | L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 6.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. |
| OG005 | L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 9.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. |
| OG006 | L-DOS47 12.0 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 12.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. |
|
|
| Primary | Number of Participants With Dose Limited Toxicities (DLTs) Related to L-DOS47 in Combination Treatment With Pemetrexed/Carboplatin. | A DLT was defined as the occurrence of any of the following events (according to NCI CTCAE version 4.0) that are considered to be (possibly/probably/definitely) related to L-DOS47 and occurring within 21 days after commencing study treatment:
| Any subject who has received all scheduled doses of L-DOS47 in Cycle 1; a DLT is assumed to have occurred if a patient does not receive all scheduled doses of L-DOS47 due to toxicity | Posted | Count of Participants | Participants | Up to 21 days |
|
|
|
| Primary | Maximum Tolerated Dose of L-DOS47 in Combination With Pemetrexed/Carboplatin | Defined as the highest dose level at which ≤ 1 of 6 patients experiences a dose limiting toxicity (DLT) as assessed during the first treatment cycle. If no DLT are reported, it is assumed that the maximum tolerated dose of L-DOS47 in combination with pemetrexed/carboplatin was not reached. | Any subject who experienced a dose-limiting toxicity (DLT); a DLT is also assumed to have occurred if a patient does not receive all scheduled doses of L-DOS47 due to toxicity | Posted | Count of Participants | Participants | 21 days |
|
|
|
| Secondary | Objective Response Rate of Patients Receiving the Combination Treatment According to RECIST 1.1 | Objective tumor response will be assessed according to RECIST version 1.1 in patients who have completed at least 2 cycles of study treatment and who have at least 1 post-treatment disease assessment; where complete response (CR) is the disappearance of all target lesions and partial response (PR) is at least a 30% reduction in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Efficacy-evaluable population includes those patients who have completed at least two cycles of study treatment and had at least one post-baseline tumor assessment. For patients with fewer than two cycles of study treatment, there had to be clear evidence of clinical progression. For patients to be evaluable for stable disease, the duration of stable disease must be at least 42 days from the first dose of study treatment. | Posted | Count of Participants | Participants | Up to 12 weeks |
|
|
|
| Secondary | Percentage of Patients Receiving a Sustained Clinical Benefit | Defined as the percentage of patients who have achieved complete response, partial response, or stable disease following combination treatment with L-DOS47 + pemetrexed/carboplatin; where complete response (CR) is the disappearance of all target lesions, partial response (PR) is at least a 30% reduction in the sum of diameters of target lesions, taking as reference the baseline sum diameters, and stable disease (SD) is where neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD, at least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study). | Efficacy-evaluable population includes those patients who have completed at least two cycles of study treatment and had at least one post-baseline tumor assessment. For patients with fewer than two cycles of study treatment, there had to be clear evidence of clinical progression. For patients to be evaluable for stable disease, the duration of stable disease must be at least 42 days from the first dose of study treatment. | Posted | Count of Participants | Participants | Up to 12 weeks |
|
|
|
| 3 |
| 3 |
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | L-DOS47 0.78 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 0.78 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. | 2 | 6 | 3 | 6 | 6 | 6 |
| EG002 | L-DOS47 1.5 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 1.5 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG003 | L-DOS47 3.0 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 3.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. | 1 | 1 | 1 | 1 | 1 | 1 |
| EG004 | L-DOS47 6.0 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 0.78 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. | 1 | 1 | 1 | 1 | 1 | 1 |
| EG005 | L-DOS47 9.0 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 9.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. | 1 | 2 | 1 | 2 | 2 | 2 |
| EG006 | L-DOS47 12.0 ug/kg in Combination With Pemetrexed and Carboplatin | Subjects were to receive a weekly dose 12.0 µg/kg of L-DOS47 by IV infusion in combination with standard of care doses of pemetrexed [500 mg/m2] and carboplatin [AUC6], where a treatment cycle was 21 days, with patients receiving L-DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle for a total of four treatment cycles. Subjects had the option to continue on weekly doses of L-DOS47 for long as there was clinical benefit and well-tolerated. | 0 | 0 | 0 | 0 | 0 | 0 |
| abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| loss of consciousness | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| syncope | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| febrile neutropenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
|
| neutropenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
|
| chest pain | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| bacteremia | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| platelet count decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| diarrhea | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| gastroesophageal reflux | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| hyperchlorhydria | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| rectal hemorrhage | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| fatigue | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| oedema peripheral | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| chest pain | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| pyrexia | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| chills | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| facial pain | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| malaise | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| pain | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| decreased appetite | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| dehydration | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| weight fluctuation | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| dyslipidaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| hyperglycaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| hypocalcaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| hypoglycaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| hypokalaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| increased appetite | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| malnutrition | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| anaemia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
|
| neutropenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
|
| febrile neutropenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
|
| thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| alopecia | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| hyperdrosis | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| macule | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| rash generalized | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| skin lesion | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| neutrophil count decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| white blood cell count decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| platelet count decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| alanine aminotransferase increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| blood creatinine increased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| lymphocyte count decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| hypertension | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
| embolism | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
| flushing | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
| hypotension | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
| pallor | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
| superior vena cava syndrome | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| bone swelling | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| myalgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| neuropathy peripheral | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| syncope | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| tremor | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| dizziness | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| loss of consciousness | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| polyneuropathy | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| bacteraemia | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| oral candidiasis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| tooth abscess | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| upper respiratory tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| urinary tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| viral upper respiratory infection | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
|
| insomnia | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
|
| anxiety | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
|
| haematuria | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
|
| defect conduction intraventricular | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
|
| tachycardia | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
|
Not provided
Not provided
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Stable disease |
|
| Progressive disease |
|