Trial Outcomes & Findings for A Study of CRLX101(NLG207) in Combination With Weekly Paclitaxel in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (NCT NCT02389985)
NCT ID: NCT02389985
Last Updated: 2026-06-18
Results Overview
Number of subjects with DLTs
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
6 months
Results posted on
2026-06-18
Participant Flow
Participant milestones
| Measure |
Dose Level 1
CRLX101 12mg/m2 on Days 1 and 15 Paclitaxel 80mg/m2 on Days 1, 8 and 15
|
Dose Level 2
CRLX101 15mg/m2 on Days 1 and 15 Paclitaxel 80mg/m2 on Days 1, 8 and 15
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
27
|
|
Overall Study
COMPLETED
|
3
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of CRLX101(NLG207) in Combination With Weekly Paclitaxel in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=3 Participants
CRLX101 12 mg/m2 on Days 1 and 15 Paclitaxel 80mg/m2 on Days 1, 8 and 15
|
Dose Level 2
n=27 Participants
CRLX101 15 mg/m2 on Days 1 and 15 Paclitaxel 80mg/m2 on Days 1, 8 and 15
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
40-49 years
|
0 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Age, Customized
50-59 years
|
1 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
Age, Customized
60-69 years
|
1 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Age, Customized
70-79 years
|
1 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=20 Participants
|
27 Participants
n=20 Participants
|
30 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=20 Participants
|
27 Participants
n=20 Participants
|
30 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=20 Participants
|
24 Participants
n=20 Participants
|
27 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
ECOG Performance Status Scale
Baseline ECOG Performance Status of 0
|
2 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
|
ECOG Performance Status Scale
Baseline ECOG Performance Status of 1
|
1 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 6 monthsNumber of subjects with DLTs
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
CRLX101 12mg/m2 on Days 1 and 15 Paclitaxel 80mg/m2 on Days 1, 8 and 15
|
Dose Level 2
n=6 Participants
CRLX101 15mg/m2 on Days 1 and 15 Paclitaxel 80mg/m2 on Days 1, 8 and 15
|
|---|---|---|
|
1. Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Responder: CR (complete response) and PR (partial response) Non-Responder: SD (stable disease) and PD (progressive disease)
Assessed using RECIST v1.0
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
CRLX101 12mg/m2 on Days 1 and 15 Paclitaxel 80mg/m2 on Days 1, 8 and 15
|
Dose Level 2
n=27 Participants
CRLX101 15mg/m2 on Days 1 and 15 Paclitaxel 80mg/m2 on Days 1, 8 and 15
|
|---|---|---|
|
Overall Response Rate
Responder
|
1 Participants
|
7 Participants
|
|
Overall Response Rate
Non-responder
|
2 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Through Month 6Population: If PFS time ≥ 6.0 months then PFS = 'not progressed' If PFS time \< 6.0 months, then PFS = 'progressed'
Assessed using RECIST v1.1
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
CRLX101 12mg/m2 on Days 1 and 15 Paclitaxel 80mg/m2 on Days 1, 8 and 15
|
Dose Level 2
n=27 Participants
CRLX101 15mg/m2 on Days 1 and 15 Paclitaxel 80mg/m2 on Days 1, 8 and 15
|
|---|---|---|
|
Progression Free Survival (PFS)
Not progressed
|
2 Participants
|
8 Participants
|
|
Progression Free Survival (PFS)
Progressed
|
1 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Duration of Response is only measure for participants that had a response (either partial response or complete response)
Assessed using RECIST 1.1
Outcome measures
| Measure |
Dose Level 1
n=1 Participants
CRLX101 12mg/m2 on Days 1 and 15 Paclitaxel 80mg/m2 on Days 1, 8 and 15
|
Dose Level 2
n=7 Participants
CRLX101 15mg/m2 on Days 1 and 15 Paclitaxel 80mg/m2 on Days 1, 8 and 15
|
|---|---|---|
|
Duration of Response
|
110 Days
Standard Deviation 0
|
193.71 Days
Standard Deviation 65.352
|
SECONDARY outcome
Timeframe: 1 yearAssessed using RECIST v1.1
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
CRLX101 12mg/m2 on Days 1 and 15 Paclitaxel 80mg/m2 on Days 1, 8 and 15
|
Dose Level 2
n=27 Participants
CRLX101 15mg/m2 on Days 1 and 15 Paclitaxel 80mg/m2 on Days 1, 8 and 15
|
|---|---|---|
|
Response Rate
Not Evaluable
|
0 Participants
|
8 Participants
|
|
Response Rate
Complete Response
|
0 Participants
|
1 Participants
|
|
Response Rate
Partial Response
|
1 Participants
|
6 Participants
|
|
Response Rate
Stable Disease
|
1 Participants
|
10 Participants
|
|
Response Rate
Progressive Disease
|
1 Participants
|
2 Participants
|
Adverse Events
Dose Level 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 2
Serious events: 15 serious events
Other events: 27 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Dose Level 1
n=3 participants at risk
CRLX101 12 mg/m2 on Days 1 and 15 Paclitaxel 80mg/m2 on Days 1, 8 and 15
|
Dose Level 2
n=27 participants at risk
CRLX101 15 mg/m2 on Days 1 and 15 Paclitaxel 80mg/m2 on Days 1, 8 and 15
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • 1 year
|
3.7%
1/27 • 1 year
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • 1 year
|
3.7%
1/27 • 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • 1 year
|
7.4%
2/27 • 1 year
|
|
General disorders
General disorders and administration site conditions - Other
|
0.00%
0/3 • 1 year
|
3.7%
1/27 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • 1 year
|
3.7%
1/27 • 1 year
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/3 • 1 year
|
7.4%
2/27 • 1 year
|
|
General disorders
Multi-organ failure
|
0.00%
0/3 • 1 year
|
3.7%
1/27 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
0.00%
0/3 • 1 year
|
3.7%
1/27 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
0.00%
0/3 • 1 year
|
3.7%
1/27 • 1 year
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • 1 year
|
3.7%
1/27 • 1 year
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • 1 year
|
7.4%
2/27 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • 1 year
|
3.7%
1/27 • 1 year
|
|
Psychiatric disorders
Suicide attempt
|
33.3%
1/3 • 1 year
|
0.00%
0/27 • 1 year
|
Other adverse events
| Measure |
Dose Level 1
n=3 participants at risk
CRLX101 12 mg/m2 on Days 1 and 15 Paclitaxel 80mg/m2 on Days 1, 8 and 15
|
Dose Level 2
n=27 participants at risk
CRLX101 15 mg/m2 on Days 1 and 15 Paclitaxel 80mg/m2 on Days 1, 8 and 15
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • 1 year
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • 1 year
|
11.1%
3/27 • Number of events 3 • 1 year
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • 1 year
|
18.5%
5/27 • Number of events 5 • 1 year
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/3 • 1 year
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Cystitis Noninfective
|
0.00%
0/3 • 1 year
|
14.8%
4/27 • Number of events 4 • 1 year
|
|
Renal and urinary disorders
Hematuria
|
66.7%
2/3 • Number of events 2 • 1 year
|
18.5%
5/27 • Number of events 7 • 1 year
|
|
Renal and urinary disorders
Urinary Frequency
|
0.00%
0/3 • 1 year
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Urinary Tract Pain
|
0.00%
0/3 • 1 year
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • 1 year
|
11.1%
3/27 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
66.7%
2/3 • Number of events 2 • 1 year
|
37.0%
10/27 • Number of events 11 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • 1 year
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
0.00%
0/3 • 1 year
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
100.0%
3/3 • Number of events 4 • 1 year
|
51.9%
14/27 • Number of events 19 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/3 • 1 year
|
11.1%
3/27 • Number of events 3 • 1 year
|
|
Skin and subcutaneous tissue disorders
Nail Discoloration
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/27 • 1 year
|
|
Skin and subcutaneous tissue disorders
Nail Loss
|
0.00%
0/3 • 1 year
|
7.4%
2/27 • Number of events 3 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/3 • 1 year
|
11.1%
3/27 • Number of events 3 • 1 year
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • 1 year
|
11.1%
3/27 • Number of events 3 • 1 year
|
|
Vascular disorders
Hot Flashes
|
0.00%
0/3 • 1 year
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • 1 year
|
18.5%
5/27 • Number of events 6 • 1 year
|
|
Vascular disorders
Thromboembolic Event
|
0.00%
0/3 • 1 year
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • 1 year
|
18.5%
5/27 • Number of events 6 • 1 year
|
|
Ear and labyrinth disorders
Ear and Labyrinth Disorders-Other
|
0.00%
0/3 • 1 year
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • 1 year
|
25.9%
7/27 • Number of events 8 • 1 year
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/3 • 1 year
|
14.8%
4/27 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • 1 year
|
18.5%
5/27 • Number of events 5 • 1 year
|
|
General disorders
Diarrhea
|
33.3%
1/3 • Number of events 1 • 1 year
|
25.9%
7/27 • Number of events 7 • 1 year
|
|
Gastrointestinal disorders
Mucositis Oral
|
0.00%
0/3 • 1 year
|
14.8%
4/27 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 2 • 1 year
|
48.1%
13/27 • Number of events 15 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • 1 year
|
22.2%
6/27 • Number of events 6 • 1 year
|
|
General disorders
Chills
|
0.00%
0/3 • 1 year
|
7.4%
2/27 • Number of events 3 • 1 year
|
|
General disorders
Edema Limbs
|
0.00%
0/3 • 1 year
|
33.3%
9/27 • Number of events 9 • 1 year
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 3 • 1 year
|
59.3%
16/27 • Number of events 18 • 1 year
|
|
General disorders
Infusion Related Reaction
|
0.00%
0/3 • 1 year
|
22.2%
6/27 • Number of events 6 • 1 year
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/3 • 1 year
|
11.1%
3/27 • Number of events 3 • 1 year
|
|
Immune system disorders
Immune System Disorders - Other
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/27 • 1 year
|
|
Infections and infestations
Nail Infection
|
0.00%
0/3 • 1 year
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/3 • 1 year
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Infections and infestations
Urinary Tract Infection
|
33.3%
1/3 • Number of events 2 • 1 year
|
22.2%
6/27 • Number of events 6 • 1 year
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/3 • 1 year
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/3 • 1 year
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Investigations
Creatinine Increased
|
0.00%
0/3 • 1 year
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Investigations
Neutrophil Count Decreased
|
100.0%
3/3 • Number of events 3 • 1 year
|
63.0%
17/27 • Number of events 24 • 1 year
|
|
Investigations
Weight Gain
|
0.00%
0/3 • 1 year
|
7.4%
2/27 • Number of events 3 • 1 year
|
|
Investigations
White Blood Cell Decreased
|
0.00%
0/3 • 1 year
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • 1 year
|
22.2%
6/27 • Number of events 6 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • Number of events 1 • 1 year
|
14.8%
4/27 • Number of events 5 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • 1 year
|
11.1%
3/27 • Number of events 3 • 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • 1 year
|
22.2%
6/27 • Number of events 6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/3 • 1 year
|
14.8%
4/27 • Number of events 4 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/3 • 1 year
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
0.00%
0/3 • 1 year
|
7.4%
2/27 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • 1 year
|
11.1%
3/27 • Number of events 3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/3 • 1 year
|
18.5%
5/27 • Number of events 5 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant and Unspecified (Incl Cysts and Polyps) - Other
|
33.3%
1/3 • Number of events 1 • 1 year
|
0.00%
0/27 • 1 year
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • 1 year
|
14.8%
4/27 • Number of events 4 • 1 year
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • 1 year
|
7.4%
2/27 • Number of events 3 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Headache
|
0.00%
0/3 • 1 year
|
18.5%
5/27 • Number of events 5 • 1 year
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
66.7%
2/3 • Number of events 2 • 1 year
|
40.7%
11/27 • Number of events 13 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60