Trial Outcomes & Findings for Paclitaxel/Carboplatin + Galunisertib for Patients With Carcinosarcoma of the Uterus or Ovary (NCT NCT03206177)
NCT ID: NCT03206177
Last Updated: 2024-08-07
Results Overview
Completion of 4 cycles of CT + GB- completion of a cycle will be defined as receiving both carboplatin/paclitaxel and taking ≥75% of the doses of GB for the cycle.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
2 years
Results posted on
2024-08-07
Participant Flow
This single site study conducted at the University of Oklahoma Stephenson Cancer Center enrolled 26 participants between August 2017 and March 2021. The first participant was enrolled on August 23, 2017 and the last participant was enrolled on March 29, 2021.
Of the 26 enrolled participants, 24 met inclusion criteria (2 participants were screen-fails) and were assigned to the study arm to receive treatment. Of the 24 participants that received treatment, 23 participants were evaluable based on the protocol.
Participant milestones
| Measure |
Paclitaxel/Carboplatin + Galunisertib
Patients will receive the following in every cycle (1 cycle=28days).
* Paclitaxel - 175 mg/m2 over 3 hours via IV on Day 1
* Carboplatin - AUC 6\* (or AUC 5\*) over 1 hour via IV on Day 1
* Galunisertib - 150mg orally twice a day on Days 4-17
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Paclitaxel/Carboplatin + Galunisertib
Patients will receive the following in every cycle (1 cycle=28days).
* Paclitaxel - 175 mg/m2 over 3 hours via IV on Day 1
* Carboplatin - AUC 6\* (or AUC 5\*) over 1 hour via IV on Day 1
* Galunisertib - 150mg orally twice a day on Days 4-17
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
One patient did not receive baseline weight measurement
Baseline characteristics by cohort
| Measure |
Paclitaxel/Carboplatin + Galunisertib
n=24 Participants
Galunisertib: Galunisertib 150mg po BID day 4-17
Paclitaxel: Paclitaxel 175 mg/m2 over 3 hours
Carboplatin: IV day 1 Carboplatin AUC 6\* over 1 hour (or 5\* if prior radiation therapy)
|
|---|---|
|
Age, Continuous
|
68.96 years
STANDARD_DEVIATION 10.16 • n=24 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=24 Participants
|
|
BMI
|
27.08 kg/m^2
STANDARD_DEVIATION 8.40 • n=23 Participants • One patient did not receive baseline weight measurement
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Evaluable patients will be defined as patients who receive at least four cycles of study treatment.
Completion of 4 cycles of CT + GB- completion of a cycle will be defined as receiving both carboplatin/paclitaxel and taking ≥75% of the doses of GB for the cycle.
Outcome measures
| Measure |
Paclitaxel/Carboplatin + Galunisertib
n=23 Participants
Galunisertib: Galunisertib 150mg po BID day 4-17
Paclitaxel: Paclitaxel 175 mg/m2 over 3 hours
Carboplatin: IV day 1 Carboplatin AUC 6\* over 1 hour (or 5\* if prior radiation therapy)
|
|---|---|
|
Proportion of Patients With Completion of 4 Cycles of CT + GB
|
0.7826 proportion of patients
Interval 0.5961 to 0.9102
|
SECONDARY outcome
Timeframe: through study completion, an average of 3 yearsPopulation: Patients who received at least four cycles of study drug.
Progression free survival is defined as time from when the patient is registered on the study until RECIST v1.1 documented disease progression as per the protocol or death.
Outcome measures
| Measure |
Paclitaxel/Carboplatin + Galunisertib
n=23 Participants
Galunisertib: Galunisertib 150mg po BID day 4-17
Paclitaxel: Paclitaxel 175 mg/m2 over 3 hours
Carboplatin: IV day 1 Carboplatin AUC 6\* over 1 hour (or 5\* if prior radiation therapy)
|
|---|---|
|
Median Progression Free Survival (Months)
|
6.55 months
Interval 5.42 to 10.81
|
SECONDARY outcome
Timeframe: through study completion, an average of 3 yearsPopulation: Patients who received at least four cycles of study drug
Overall survival defined as time from study entry to death
Outcome measures
| Measure |
Paclitaxel/Carboplatin + Galunisertib
n=23 Participants
Galunisertib: Galunisertib 150mg po BID day 4-17
Paclitaxel: Paclitaxel 175 mg/m2 over 3 hours
Carboplatin: IV day 1 Carboplatin AUC 6\* over 1 hour (or 5\* if prior radiation therapy)
|
|---|---|
|
Median Overall Survival (Months)
|
18.91 months
Interval 10.81 to
The curve that represents the upper confidence limit never crosses below 0.5 and therefore an upper bound for the median value cannot be calculated.
|
SECONDARY outcome
Timeframe: within three years of study entryPopulation: Patients who received four cycles of study drugs
Proportion of patients who had RECIST documented partial or complete response. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be ≥ 10 mm when measured by CT and MRI; or ≥ 20 mm when measured by conventional techniques, including plain x-ray. Response was documented per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions.
Outcome measures
| Measure |
Paclitaxel/Carboplatin + Galunisertib
n=21 Participants
Galunisertib: Galunisertib 150mg po BID day 4-17
Paclitaxel: Paclitaxel 175 mg/m2 over 3 hours
Carboplatin: IV day 1 Carboplatin AUC 6\* over 1 hour (or 5\* if prior radiation therapy)
|
|---|---|
|
Objective Response
|
0.33 proportion of patients with CR/PR
Interval 0.15 to 0.57
|
Adverse Events
Paclitaxel/Carboplatin + Galunisertib
Serious events: 11 serious events
Other events: 23 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Paclitaxel/Carboplatin + Galunisertib
n=24 participants at risk
Galunisertib: Galunisertib 150mg po BID day 4-17
Paclitaxel: Paclitaxel 175 mg/m2 over 3 hours
Carboplatin: IV day 1 Carboplatin AUC 6\* over 1 hour (or 5\* if prior radiation therapy)
|
|---|---|
|
Cardiac disorders
ARTRIAL FIBRILLATION
|
4.2%
1/24 • Within 4 years of study entry
|
|
Gastrointestinal disorders
SMALL BOWEL OBSTRUCTION
|
4.2%
1/24 • Within 4 years of study entry
|
|
Gastrointestinal disorders
VOMITING
|
4.2%
1/24 • Within 4 years of study entry
|
|
General disorders
DEATH
|
4.2%
1/24 • Within 4 years of study entry
|
|
General disorders
FEVER
|
4.2%
1/24 • Within 4 years of study entry
|
|
General disorders
NEUTROPENIC FEVER
|
4.2%
1/24 • Within 4 years of study entry
|
|
Infections and infestations
PULMONARY INFECTION
|
4.2%
1/24 • Within 4 years of study entry
|
|
Infections and infestations
URINARY TRACT INFECTION
|
4.2%
1/24 • Within 4 years of study entry
|
|
Injury, poisoning and procedural complications
DRUG INDUCED LIVER INJURY
|
4.2%
1/24 • Within 4 years of study entry
|
|
Musculoskeletal and connective tissue disorders
LEFT LEG FRACTURE
|
4.2%
1/24 • Within 4 years of study entry
|
|
Nervous system disorders
STROKE
|
4.2%
1/24 • Within 4 years of study entry
|
|
Nervous system disorders
SYNCOPE
|
4.2%
1/24 • Within 4 years of study entry
|
|
Psychiatric disorders
CONFUSION
|
4.2%
1/24 • Within 4 years of study entry
|
|
Reproductive system and breast disorders
VAGINAL BLEEDING
|
4.2%
1/24 • Within 4 years of study entry
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
4.2%
1/24 • Within 4 years of study entry
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY FIBROSIS
|
4.2%
1/24 • Within 4 years of study entry
|
|
Respiratory, thoracic and mediastinal disorders
SHORTNESS OF BREATH
|
4.2%
1/24 • Within 4 years of study entry
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
4.2%
1/24 • Within 4 years of study entry
|
Other adverse events
| Measure |
Paclitaxel/Carboplatin + Galunisertib
n=24 participants at risk
Galunisertib: Galunisertib 150mg po BID day 4-17
Paclitaxel: Paclitaxel 175 mg/m2 over 3 hours
Carboplatin: IV day 1 Carboplatin AUC 6\* over 1 hour (or 5\* if prior radiation therapy)
|
|---|---|
|
Blood and lymphatic system disorders
ANEMIA
|
16.7%
4/24 • Within 4 years of study entry
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
41.7%
10/24 • Within 4 years of study entry
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
16.7%
4/24 • Within 4 years of study entry
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
8.3%
2/24 • Within 4 years of study entry
|
|
Gastrointestinal disorders
CONSTIPATION
|
16.7%
4/24 • Within 4 years of study entry
|
|
Gastrointestinal disorders
GERD
|
8.3%
2/24 • Within 4 years of study entry
|
|
Gastrointestinal disorders
INTERMITTENT NAUSEA
|
12.5%
3/24 • Within 4 years of study entry
|
|
Gastrointestinal disorders
NAUSEA
|
37.5%
9/24 • Within 4 years of study entry
|
|
Gastrointestinal disorders
VOMITING
|
8.3%
2/24 • Within 4 years of study entry
|
|
General disorders
FATIGUE
|
45.8%
11/24 • Within 4 years of study entry
|
|
General disorders
INFUSION REACTION
|
8.3%
2/24 • Within 4 years of study entry
|
|
General disorders
INFUSION RELATED REACTION
|
8.3%
2/24 • Within 4 years of study entry
|
|
General disorders
INTERMITTENT FATIGUE
|
8.3%
2/24 • Within 4 years of study entry
|
|
Infections and infestations
URINARY TRACT INFECTION
|
25.0%
6/24 • Within 4 years of study entry
|
|
Injury, poisoning and procedural complications
FALL
|
12.5%
3/24 • Within 4 years of study entry
|
|
Metabolism and nutrition disorders
ANOREXIA
|
16.7%
4/24 • Within 4 years of study entry
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
12.5%
3/24 • Within 4 years of study entry
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
33.3%
8/24 • Within 4 years of study entry
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
12.5%
3/24 • Within 4 years of study entry
|
|
Nervous system disorders
DIZZINESS
|
12.5%
3/24 • Within 4 years of study entry
|
|
Nervous system disorders
DYSGEUSIA
|
12.5%
3/24 • Within 4 years of study entry
|
|
Nervous system disorders
HEADACHE
|
12.5%
3/24 • Within 4 years of study entry
|
|
Nervous system disorders
NEUROPATHY
|
54.2%
13/24 • Within 4 years of study entry
|
|
Nervous system disorders
PERIPHERAL NEUROPATHY
|
8.3%
2/24 • Within 4 years of study entry
|
|
Psychiatric disorders
INSOMNIA
|
8.3%
2/24 • Within 4 years of study entry
|
|
Reproductive system and breast disorders
VAGINAL BLEEDING
|
8.3%
2/24 • Within 4 years of study entry
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
12.5%
3/24 • Within 4 years of study entry
|
|
Respiratory, thoracic and mediastinal disorders
SHORTNESS OF BREATH
|
8.3%
2/24 • Within 4 years of study entry
|
|
Skin and subcutaneous tissue disorders
RASH
|
20.8%
5/24 • Within 4 years of study entry
|
Additional Information
Dr. Kathleen Moore
University of Oklahoma Health Sciences Center, Stephenson Cancer Center
Phone: 405-271-8777
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place