Trial Outcomes & Findings for Dichloroacetate (DCA) in Patients With Previously Treated Metastatic Breast or Non-Small Cell Lung Cancer (NSCL) (NCT NCT01029925)

Last Updated: 2016-02-12

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

upto 72 days

Results posted on

2016-02-12

Participant Flow

Patients with breast cancer (1) and non-small cell lung cancer (6) were recruited at UCLA between January 2010 and December 2010.

One patient developed a brain metastasis before beginning therapy and had to be excluded, and two patients were undergoing screening procedures when the study was placed on voluntary hold.

Participant milestones

Participant milestones
Measure	Dichloroacetate (DCA) Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
Completion of Cycle 1 (28 Days) STARTED	7
Completion of Cycle 1 (28 Days) COMPLETED	3
Completion of Cycle 1 (28 Days) NOT COMPLETED	4
Completion of Cycle 2 (56 Days) STARTED	3
Completion of Cycle 2 (56 Days) COMPLETED	2
Completion of Cycle 2 (56 Days) NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Dichloroacetate (DCA) Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
Completion of Cycle 1 (28 Days) Death	2
Completion of Cycle 1 (28 Days) Withdrawal by Subject	2
Completion of Cycle 2 (56 Days) off study due to disease progression	1

Baseline Characteristics

Dichloroacetate (DCA) in Patients With Previously Treated Metastatic Breast or Non-Small Cell Lung Cancer (NSCL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dichloroacetate (DCA) n=7 Participants Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
stage at diagnosis Stage II breast cancer	1 participants n=5 Participants
stage at diagnosis Stage IV NSCLC	6 participants n=5 Participants
ECOG status ECOG status 0	2 participants n=5 Participants
ECOG status ECOG status 1	3 participants n=5 Participants
ECOG status ECOG status 2	2 participants n=5 Participants

PRIMARY outcome

Timeframe: upto 72 days

Population: Intent to treat analysis was performed. Zero patients achieved complete or partial response in this study.

Outcome measures

Outcome measures
Measure	Dichloroacetate (DCA) n=7 Participants Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
Response Rate by RECIST Criteria of Oral Dichloroacetate in Patients With Recurrent and/or Metastatic and Pretreated Breast and Non-small Cell Lung Cancer.	0 participants

Adverse Events

Dichloroacetate (DCA)

Serious events: 4 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dichloroacetate (DCA) n=7 participants at risk Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
General disorders Sudden death	28.6% 2/7 • Number of events 2
General disorders pulmonary embolism	28.6% 2/7 • Number of events 2

Other adverse events

Other adverse events
Measure	Dichloroacetate (DCA) n=7 participants at risk Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
Gastrointestinal disorders abdominal pain	28.6% 2/7 • Number of events 3
General disorders Fever	14.3% 1/7 • Number of events 1
General disorders fatigue	28.6% 2/7 • Number of events 3
Blood and lymphatic system disorders lower extremity edema	28.6% 2/7 • Number of events 3
Renal and urinary disorders urinary retention	14.3% 1/7 • Number of events 1
General disorders Dyspnea	28.6% 2/7 • Number of events 2
Gastrointestinal disorders constipation	14.3% 1/7 • Number of events 1
General disorders Xerostomia	14.3% 1/7 • Number of events 1
Gastrointestinal disorders vomiting	14.3% 1/7 • Number of events 1
General disorders tremor	14.3% 1/7 • Number of events 1
General disorders nausea	14.3% 1/7 • Number of events 1
Infections and infestations candidiasis	28.6% 2/7 • Number of events 2
General disorders disequilibrium	28.6% 2/7 • Number of events 2
General disorders lower extremity coldness	14.3% 1/7 • Number of events 1
Metabolism and nutrition disorders elevated AST	14.3% 1/7 • Number of events 1
General disorders pain	28.6% 2/7 • Number of events 2
General disorders seizures	14.3% 1/7 • Number of events 1
General disorders hyponatremia	14.3% 1/7 • Number of events 1
General disorders volume depletion	14.3% 1/7 • Number of events 1

Additional Information

Edward Garon, MD

University of California Los Angeles Jonsson Comprehensive Cancer Center

Phone: 310 586 2098

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place